Human cells may not be unlike electric batteries. They from time to time have small energy retailers or can’t hold vigor. Micro Present-day Stimulation Remedy provides your cells with all the “energy” it takes, similar in order to recharging a new battery. Studies in addition have shown this MCS Remedy increases microcirculatory circulation, increases ATP concentrations plus stimulates amino acidity and source of nourishment concentrations directly into cells.
Every located cell inside body has a power charge. It is theorized that a part of what creates macular degeneration is usually a loss with the energy source inside cell, or losing the electrical charge. As being a flashlight will not likely work without getting a charged battery pack, the photoreceptors inside retina will not likely function not having an energy source. MCS Remedy is shown to increase the energy source within your cell.
This Macular Degeneration Foundation identified in starting pre-clinical trials by groundbreaking ophthalmologists plus researchers this micro present-day stimulation therapy can boost visual acuity, sharpness plus color perception in 68 percentage of individuals with dry out macular weakening and 58 percent of those with your wet kind. Reports from Russia advocate similar benefits.
A review published by way of Dr. Merrell J. Allen plus Dr. Leland N. Michael eligible Nutritional By using supplements, Electrical Excitement and Age Related Macular Degeneration showed this 60 percentage of individuals showed much better in visible acuity following combining micro present-day stimulation therapy and natural supplementation.
Drs. Leeway Halloran plus August L. Viewer studied 25 individuals declared with generally untreatable vision diseases including macular weakening, retinitis pigmentosa, CMV-retinitis, plus diabetic retinopathy. The individuals were handled with combining micro present-day stimulation therapy and natural supplementation. Overall final results showed outstanding increase with visual job in visible acuity in many and plainly established your safety with the combination of MCS therapy and natural supplementation.
Showing posts with label blurry vision. Show all posts
Showing posts with label blurry vision. Show all posts
Friday, January 28, 2011
Sunday, January 23, 2011
Sustained-release implants on track for retinal vascular disease treatment
by:Elias Reichel
KAANAPALI, Hawaii — Sustained-release corticosteroids will play a significant role in retinal vascular disease, but the current implants still need improvements, one presenter here said.
"It is important to realize [steroids] will have a continued role in our treatment of diseases. They may also serve for adjunctive [therapies] like stem cell treatments and [instances] where transplantation or immunoreactions may occur," Elias Reichel, MD, who discussed outcomes using Ozurdex (dexamethasone intravitreal implant, Allergan) and Iluvien (fluocinolone acetonide intravitreal implant, Alimera), said at Retina 2011. "So, having a better delivery system for corticosteroids is very useful for many of the diseases we are seeing in our offices."
Challenges include needing to achieve and maintain clinically effective concentrations in the vitreous over time while maximizing efficacy and minimizing adverse effects, Dr. Reichel said.
As part of a 6-month study, the dexamethasone implant demonstrated 2- to 3-month peak efficacy, had a low incidence of IOP issues and conferred a cataract progression of approximately 5%. Additionally, 45% of the patients gained three lines of visual acuity, Dr. Reichel said.
The U.S. Food and Drug Administration has approved the device for all retinal venous obstructive disease.
The fluocinolone implant is now part of a 36-month study and has demonstrated efficacy to at least 30 months. Between 30% and 40% of patients gained at least three lines of visual acuity. However, the device has a moderately higher risk of IOP issues and a cataract progression rate of 50%, according to Dr. Reichel.
The device has received a complete response letter from the FDA.
"Current formulations that we have are good but can be better," Dr. Reichel said. "We really have to look at longer duration and this reduced risk trade-off."
* Disclosure: Dr. Reichel is a consultant to Alimera and Allergan.
KAANAPALI, Hawaii — Sustained-release corticosteroids will play a significant role in retinal vascular disease, but the current implants still need improvements, one presenter here said.
"It is important to realize [steroids] will have a continued role in our treatment of diseases. They may also serve for adjunctive [therapies] like stem cell treatments and [instances] where transplantation or immunoreactions may occur," Elias Reichel, MD, who discussed outcomes using Ozurdex (dexamethasone intravitreal implant, Allergan) and Iluvien (fluocinolone acetonide intravitreal implant, Alimera), said at Retina 2011. "So, having a better delivery system for corticosteroids is very useful for many of the diseases we are seeing in our offices."
Challenges include needing to achieve and maintain clinically effective concentrations in the vitreous over time while maximizing efficacy and minimizing adverse effects, Dr. Reichel said.
As part of a 6-month study, the dexamethasone implant demonstrated 2- to 3-month peak efficacy, had a low incidence of IOP issues and conferred a cataract progression of approximately 5%. Additionally, 45% of the patients gained three lines of visual acuity, Dr. Reichel said.
The U.S. Food and Drug Administration has approved the device for all retinal venous obstructive disease.
The fluocinolone implant is now part of a 36-month study and has demonstrated efficacy to at least 30 months. Between 30% and 40% of patients gained at least three lines of visual acuity. However, the device has a moderately higher risk of IOP issues and a cataract progression rate of 50%, according to Dr. Reichel.
The device has received a complete response letter from the FDA.
"Current formulations that we have are good but can be better," Dr. Reichel said. "We really have to look at longer duration and this reduced risk trade-off."
* Disclosure: Dr. Reichel is a consultant to Alimera and Allergan.
Monday, December 20, 2010
New Investment to Boost Gene Therapy Development
National Neurovision Research Institute (NNRI), the Foundation Fighting Blindness’ clinical trial support organization, announced today that one of its key partners, biopharmaceutical company Oxford BioMedica, has established a collaboration with sanofi-aventis, a major international pharmaceutical company, to develop and commercialize gene therapy treatments for vision-robbing retinal degenerative diseases that affect tens of millions of people around the world.
The collaboration will significantly bolster the development of the following gene therapy products: StarGen™ for the treatment of Stargardt disease, a form of early-onset macular degeneration; UshStat™ for the treatment of Usher syndrome, the leading cause of deaf-blindness; and RetinoStat® for the treatment of age-related macular degeneration, the leading cause vision loss in people 55 and older in developed countries.
The development of treatments for these and other retinal degenerative diseases is a key goal of the National Neurovision Research Institute and is the basis for its partnership with Oxford BioMedica. In 2006, Paul and Diane Manning, with the National Neurovision Research Institute, established a partnership with Oxford BioMedica to advance gene therapies for these and other related retinal degenerative diseases.
“The investment from sanofi-aventis is a wonderful boost for the development of Oxford BioMedica’s gene therapy products and will greatly enhance our ability to move these emerging treatments into and through the clinical trial process,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “This collaboration affirms the great potential for gene therapy to treat and cure a number of retinal degenerative diseases including Stargardt disease and Usher syndrome that, as rare diseases, often do not receive the attention or investment necessary to bring about promising treatments.”
“An important goal of the Foundation, through NNRI, is to attract investment from large pharmaceutical companies for the development and production of treatments for inherited retinal disease,” says Morton Goldberg, M.D., chairman of the board of NNRI. “The NNRI-Oxford partnership is an excellent model of how NNRI collaborations can accelerate the translation of laboratory-based research into clinical trials, ultimately getting successful treatments for rare diseases like inherited retinal degenerations to the market and out to the people who need them.”
Based on the agreement, Oxford BioMedica will receive an upfront payment of $26 million and a further $24 million from sanofi-aventis over a three-year period.
The treatments will utilize Oxford BioMedica’s LentiVector® gene delivery technology to deliver healthy vision-saving genes to the retina. For more information on this technology, visit www.oxfordbiomedica.co.uk/
The collaboration will significantly bolster the development of the following gene therapy products: StarGen™ for the treatment of Stargardt disease, a form of early-onset macular degeneration; UshStat™ for the treatment of Usher syndrome, the leading cause of deaf-blindness; and RetinoStat® for the treatment of age-related macular degeneration, the leading cause vision loss in people 55 and older in developed countries.
The development of treatments for these and other retinal degenerative diseases is a key goal of the National Neurovision Research Institute and is the basis for its partnership with Oxford BioMedica. In 2006, Paul and Diane Manning, with the National Neurovision Research Institute, established a partnership with Oxford BioMedica to advance gene therapies for these and other related retinal degenerative diseases.
“The investment from sanofi-aventis is a wonderful boost for the development of Oxford BioMedica’s gene therapy products and will greatly enhance our ability to move these emerging treatments into and through the clinical trial process,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “This collaboration affirms the great potential for gene therapy to treat and cure a number of retinal degenerative diseases including Stargardt disease and Usher syndrome that, as rare diseases, often do not receive the attention or investment necessary to bring about promising treatments.”
“An important goal of the Foundation, through NNRI, is to attract investment from large pharmaceutical companies for the development and production of treatments for inherited retinal disease,” says Morton Goldberg, M.D., chairman of the board of NNRI. “The NNRI-Oxford partnership is an excellent model of how NNRI collaborations can accelerate the translation of laboratory-based research into clinical trials, ultimately getting successful treatments for rare diseases like inherited retinal degenerations to the market and out to the people who need them.”
Based on the agreement, Oxford BioMedica will receive an upfront payment of $26 million and a further $24 million from sanofi-aventis over a three-year period.
The treatments will utilize Oxford BioMedica’s LentiVector® gene delivery technology to deliver healthy vision-saving genes to the retina. For more information on this technology, visit www.oxfordbiomedica.co.uk/
Monday, December 6, 2010
Drug Therapy To Cure Macular Degeneration
By Administration
Lucentis-is a drug therapy based on the cancer drug Avastin for wet macular degeneration. The treatment involves periodic injection of the drug directly into the eye. A higher percentage of those treated with Lucentis have shown improved vision than with any other treatment. Macugen-is another drug therapy for macular degeneration. It also involves periodic injections directly into the eye. It employs a molecule that attacks a protein involved with the growth of macular degeneration related blood vessels. macular degeneration treatment Vitamins and Minerals-are a treatment that is being used to treat dry macular degeneration. There is evidence to suggest that vitamins and minerals that have antioxidant properties will slow the progression of intermediate dry macular degeneration to the advanced form. The treatment typically involves large doses of Vitamin C, Vitamin E, Beta Carotene and Zinc Oxide.
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Lucentis-is a drug therapy based on the cancer drug Avastin for wet macular degeneration. The treatment involves periodic injection of the drug directly into the eye. A higher percentage of those treated with Lucentis have shown improved vision than with any other treatment. Macugen-is another drug therapy for macular degeneration. It also involves periodic injections directly into the eye. It employs a molecule that attacks a protein involved with the growth of macular degeneration related blood vessels. macular degeneration treatment Vitamins and Minerals-are a treatment that is being used to treat dry macular degeneration. There is evidence to suggest that vitamins and minerals that have antioxidant properties will slow the progression of intermediate dry macular degeneration to the advanced form. The treatment typically involves large doses of Vitamin C, Vitamin E, Beta Carotene and Zinc Oxide.
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Sunday, November 28, 2010
Melatonin for Macular Degeneration?
By Cathy Wong, Alternative Medicine Guide
Melatonin may help treat age-related macular degeneration, according to a recent report. A leading cause of blindness in the United States, age-related macular degeneration develops when certain cells in the retina deteriorate and gradually destroy your central vision.
A hormone with antioxidant effects, melatonin may help stop shortening of telomeres (chromosomal structures that become shorter over time due to factors like aging, inflammation, and damage caused by free radicals). By preventing telomere-shortening in the cells of the retina, the report suggests, melatonin may help preserve eyesight and slow the progression of age-related macular degeneration.
While melatonin shows promise as a natural remedy for age-related macular degeneration, it's too soon to recommend melatonin supplements for this condition. For help in protecting your eyesight as you age, wear UV-protective lenses when outdoors in the daylight and consider upping your intake of foods rich in lutein (such as leafy green vegetables, green beans, and mango).
As always please check with your doctor before starting/ or changing any medications or supplements.
Melatonin may help treat age-related macular degeneration, according to a recent report. A leading cause of blindness in the United States, age-related macular degeneration develops when certain cells in the retina deteriorate and gradually destroy your central vision.
A hormone with antioxidant effects, melatonin may help stop shortening of telomeres (chromosomal structures that become shorter over time due to factors like aging, inflammation, and damage caused by free radicals). By preventing telomere-shortening in the cells of the retina, the report suggests, melatonin may help preserve eyesight and slow the progression of age-related macular degeneration.
While melatonin shows promise as a natural remedy for age-related macular degeneration, it's too soon to recommend melatonin supplements for this condition. For help in protecting your eyesight as you age, wear UV-protective lenses when outdoors in the daylight and consider upping your intake of foods rich in lutein (such as leafy green vegetables, green beans, and mango).
As always please check with your doctor before starting/ or changing any medications or supplements.
Monday, November 15, 2010
Macular Degeneration Treatments/Therapies Breakthroughs
by Isobel Washington
Macular degeneration is an eye condition characterized by the deterioration of the macula, which is the central "lens-like" part of the eye's retina responsible for sharp central vision. Affecting central vision and often leading to vision loss, macular degeneration has had limited treatment options. Recently, there have been some breakthroughs to help patients retain vision.
Significance
Macular degeneration is the leading cause of vision loss and blindness among Americans age 65 and older. Vision loss from this condition is a growing problem, since this age demographic represents an increasingly larger percentage of the U. S. population.
Function
Treatments for macular degeneration work to preserve vision ability at the time of treatment, and slow the progression of the disease (it's a progressive disease that affects vision over time). Treatment cannot restore vision that is already lost through the disease. There is no cure or treatment to stop the progression of macular degeneration, there are ways to preserve and prolong current vision.
Eye Injections
Lucentis and Macugen are FDA-approved ocular injection treatments, and are highly effective for preserving vision and inhibiting macular degeneration symptoms, according to AllAboutVision.com. A 2005 study on Lucentis demonstrated success rate of 95 percent for improving and sustaining vision in macular degeneration patients.
Laser Treatment
Laser technology is now used to destroy the abnormal, leaky blood vessels that cause vision loss in macular degeneration patients. The National Eye Institute points out, however, that while this treatment may be effective for preventing vision loss, it is also comes with the risk of destroying healthy tissue that surrounds the treatment area.
Photodynamic Therapy
This method uses special light treatment to activate an injected drug, verteporfin, in the blood vessels, so that it destroys the new, abnormal blood vessels being hyper-produced in the eye (those that cause vision impairment or loss). The National Eye Institute reports that this light-activation method slows vision loss, but doesn't stop it.
Investigational Treatments
Investigational treatments for macular degeneration, in various stages of research and FDA clinical studies, include Avastin, a cancer treatment drug. As of 2009, the National Eye Institute reports that no available treatment provides a cure for macular degeneration, and that vision loss may result, despite treatment.
About the Author
Isobel Washington has been a freelance journalist since 2007. Washington's work first surfaced in Europe, where she served as a restaurant critic and journalist for "LifeStyles" magazine. Her love of travel and culture inspired her first novel, which is currently underway. Washington has a 10-year career in marketing communication and holds a Bachelor of Science degree.
Macular degeneration is an eye condition characterized by the deterioration of the macula, which is the central "lens-like" part of the eye's retina responsible for sharp central vision. Affecting central vision and often leading to vision loss, macular degeneration has had limited treatment options. Recently, there have been some breakthroughs to help patients retain vision.
Significance
Macular degeneration is the leading cause of vision loss and blindness among Americans age 65 and older. Vision loss from this condition is a growing problem, since this age demographic represents an increasingly larger percentage of the U. S. population.
Function
Treatments for macular degeneration work to preserve vision ability at the time of treatment, and slow the progression of the disease (it's a progressive disease that affects vision over time). Treatment cannot restore vision that is already lost through the disease. There is no cure or treatment to stop the progression of macular degeneration, there are ways to preserve and prolong current vision.
Eye Injections
Lucentis and Macugen are FDA-approved ocular injection treatments, and are highly effective for preserving vision and inhibiting macular degeneration symptoms, according to AllAboutVision.com. A 2005 study on Lucentis demonstrated success rate of 95 percent for improving and sustaining vision in macular degeneration patients.
Laser Treatment
Laser technology is now used to destroy the abnormal, leaky blood vessels that cause vision loss in macular degeneration patients. The National Eye Institute points out, however, that while this treatment may be effective for preventing vision loss, it is also comes with the risk of destroying healthy tissue that surrounds the treatment area.
Photodynamic Therapy
This method uses special light treatment to activate an injected drug, verteporfin, in the blood vessels, so that it destroys the new, abnormal blood vessels being hyper-produced in the eye (those that cause vision impairment or loss). The National Eye Institute reports that this light-activation method slows vision loss, but doesn't stop it.
Investigational Treatments
Investigational treatments for macular degeneration, in various stages of research and FDA clinical studies, include Avastin, a cancer treatment drug. As of 2009, the National Eye Institute reports that no available treatment provides a cure for macular degeneration, and that vision loss may result, despite treatment.
About the Author
Isobel Washington has been a freelance journalist since 2007. Washington's work first surfaced in Europe, where she served as a restaurant critic and journalist for "LifeStyles" magazine. Her love of travel and culture inspired her first novel, which is currently underway. Washington has a 10-year career in marketing communication and holds a Bachelor of Science degree.
Saturday, October 30, 2010
Retinal Disease Highlights From the 2010 AAO Meeting
By Dr. Randall Wong
Many of us just returned from the largest ophthalmic “trade show” in the world. The American Academy of Ophthalmology convened in Chicago last week. This meeting was combined with the Middle East Africa Council of Ophthalmology (MEACO). Perhaps 40 K attended the meeting.
I also attended the 2 day retinal subspecialty meeting which preceded the larger AAO meeting. Thus, I had 5 days to expand my knowledge.
Most of the congress was focused on technology, especially electronic medical records. Few discoveries were revealed. This may be for two reasons: there is nothing really new going on right now, and/or, the Internet allows such rapid sharing of information, that it is impossible to “wow” anyone at this meeting. Probably both are true.
With regard to retinal disease, my particular specialty, there is little new, but lots to be excited about.
Avastin and Lucentis continue to be the mainstays of treatment for wet macular degeneration. There is evidence that the two drugs are similar in clinical efficacy…a notion I support. It is likely that these types of drugs will be delivered with a sustained release system, thus, obviating the need for repeated intraocular injections.
Ozurdex is now indicated for the treatment of uveitis. It was originally FDA approved for the treatment of RVO only. By itself, not earth-shattering, but does make sense clinically. Sustained release steroids for chronic intraocular inflammation. Sounds much better.
The highlight of the meeting is the potential for Iluvien to be FDA approved soon. Iluvien is similar to Ozurdex in that both are injectable intraocular sustained release systems. Iluvien will be a sustained release system that delivers intraocular steroids for the treatment of diabetic macular edema. While this is a particularly promising development for patients with diabetic retinopathy, this has larger implications for eye treatment overall.
What Does This Mean? Illuvien is likely to be the second FDA approved intraocular drug delivery system. This will be a significant endorsement of drug delivery to the eye. We are entering a new era of pharmaceutical therapeutics; sustained release inside the eye. For now, we are focused on retinal disease. But soon, very soon, devices will emerge promising better therapeutics for almost any eye condition.
Just think, glaucoma may be treated by such a device.
Many of us just returned from the largest ophthalmic “trade show” in the world. The American Academy of Ophthalmology convened in Chicago last week. This meeting was combined with the Middle East Africa Council of Ophthalmology (MEACO). Perhaps 40 K attended the meeting.
I also attended the 2 day retinal subspecialty meeting which preceded the larger AAO meeting. Thus, I had 5 days to expand my knowledge.
Most of the congress was focused on technology, especially electronic medical records. Few discoveries were revealed. This may be for two reasons: there is nothing really new going on right now, and/or, the Internet allows such rapid sharing of information, that it is impossible to “wow” anyone at this meeting. Probably both are true.
With regard to retinal disease, my particular specialty, there is little new, but lots to be excited about.
Avastin and Lucentis continue to be the mainstays of treatment for wet macular degeneration. There is evidence that the two drugs are similar in clinical efficacy…a notion I support. It is likely that these types of drugs will be delivered with a sustained release system, thus, obviating the need for repeated intraocular injections.
Ozurdex is now indicated for the treatment of uveitis. It was originally FDA approved for the treatment of RVO only. By itself, not earth-shattering, but does make sense clinically. Sustained release steroids for chronic intraocular inflammation. Sounds much better.
The highlight of the meeting is the potential for Iluvien to be FDA approved soon. Iluvien is similar to Ozurdex in that both are injectable intraocular sustained release systems. Iluvien will be a sustained release system that delivers intraocular steroids for the treatment of diabetic macular edema. While this is a particularly promising development for patients with diabetic retinopathy, this has larger implications for eye treatment overall.
What Does This Mean? Illuvien is likely to be the second FDA approved intraocular drug delivery system. This will be a significant endorsement of drug delivery to the eye. We are entering a new era of pharmaceutical therapeutics; sustained release inside the eye. For now, we are focused on retinal disease. But soon, very soon, devices will emerge promising better therapeutics for almost any eye condition.
Just think, glaucoma may be treated by such a device.
Saturday, October 23, 2010
Novartis therapy Lucentis recommended for approval in EU to treat Diabetic Macular Edema
By Thomas Reuters
- CHMP positive opinion supports Lucentis approval in EU for treatment in patients with visual impairment due to diabetic macular edema (DME)
- Pivotal data shows Lucentis provided rapid, superior and sustained vision gains compared to the current standard of care
- Diabetes-associated eye diseases such as DME are a leading cause of blindness in most developed countries in the working-age population
Basel, October 22, 2010 - Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lucentis(R) (ranibizumab) for the treatment of patients with visual impairment due to diabetic macular edema (DME), a leading cause of blindness in the working-age population in most developed countries.
"Lucentis was designed specifically for use in the eye, and its efficacy and safety have now been demonstrated in patients suffering loss of vision due to diabetic macular edema through a robust program of clinical trials," said David Epstein, Division Head of Novartis Pharmaceuticals.
The submission was supported by data from two Novartis-funded clinical trials, RESTORE and RESOLVE, which showed that Lucentis was superior in providing rapid and sustained visual acuity gain versus sham (dummy therapy) or laser therapy, the current standard of care. The RESTORE study showed patients treated with Lucentis alone or with Lucentis plus laser therapy achieved an average 5.9 letters and 5.5 letters gain in visual acuity at 12 months, respectively, compared to laser-treated patients as measured on a standard ETDRS eye chart.
The RESOLVE study showed that Lucentis-treated patients achieved an average 11.7 letters gain in visual acuity at 12 months compared to sham-treated patients, some of whom received laser treatment.
The pivotal data from RESTORE and RESOLVE are further supported by results of an independent US study conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), showing that at one year nearly 50% of patients' eyes treated with Lucentis and laser therapy improved their visual acuity by 10 letters or more, compared to 28% with laser alone. In addition, the study demonstrated superior gains in visual acuity among Lucentis-treated patients up to two years.
Lucentis was generally well tolerated in clinical studies, either when given as monotherapy or when combined with laser treatment. Its safety profile was consistent with that previously reported in large controlled clinical trials, and in rigorous monitoring since Lucentis was first approved for wet age-related macular degeneration (AMD). Lucentis is currently licensed in more than 85 countries for the treatment of wet AMD.
Diabetic macular edema (DME) is a consequence of diabetic retinopathy - the most common diabetic eye complication, characterized by changes in the blood vessels of the retina - to the light-sensitive layer at the back of the eye. In patients with DME, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DME can lead to significant visual impairment. Visual impairment due to DME affects approximately 1-3% of patients with diabetes, and DME is a leading cause of blindness in the working-age population in most developed countries.
Lucentis offers an entirely new pharmacological approach to treatment compared to the current standard of care for DME that involves the use of laser burns to stop the capillary leakage and to reduce swelling. Lucentis is an antibody fragment that is injected into the eye and acts by neutralizing vascular endothelial growth factor (VEGF), a protein that is known to increase vascular permeability, resulting in capillary leakage and macular edema in patients with diabetes.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States where Lucentis is also approved for the treatment of macular edema following retinal vein occlusion (RVO). In addition, Genentech is conducting two Phase III studies, RISE and RIDE, in patients with diabetic macular edema. The results are expected in 2011. Novartis has exclusive rights in the rest of the world and plans to file in the European Union for approval of Lucentis for the treatment of visual impairment due to macular edema following RVO.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "recommended," "plans," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Lucentis or regarding potential future revenues from Lucentis. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Lucentis to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lucentis will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that Lucentis will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Lucentis could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
- CHMP positive opinion supports Lucentis approval in EU for treatment in patients with visual impairment due to diabetic macular edema (DME)
- Pivotal data shows Lucentis provided rapid, superior and sustained vision gains compared to the current standard of care
- Diabetes-associated eye diseases such as DME are a leading cause of blindness in most developed countries in the working-age population
Basel, October 22, 2010 - Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lucentis(R) (ranibizumab) for the treatment of patients with visual impairment due to diabetic macular edema (DME), a leading cause of blindness in the working-age population in most developed countries.
"Lucentis was designed specifically for use in the eye, and its efficacy and safety have now been demonstrated in patients suffering loss of vision due to diabetic macular edema through a robust program of clinical trials," said David Epstein, Division Head of Novartis Pharmaceuticals.
The submission was supported by data from two Novartis-funded clinical trials, RESTORE and RESOLVE, which showed that Lucentis was superior in providing rapid and sustained visual acuity gain versus sham (dummy therapy) or laser therapy, the current standard of care. The RESTORE study showed patients treated with Lucentis alone or with Lucentis plus laser therapy achieved an average 5.9 letters and 5.5 letters gain in visual acuity at 12 months, respectively, compared to laser-treated patients as measured on a standard ETDRS eye chart.
The RESOLVE study showed that Lucentis-treated patients achieved an average 11.7 letters gain in visual acuity at 12 months compared to sham-treated patients, some of whom received laser treatment.
The pivotal data from RESTORE and RESOLVE are further supported by results of an independent US study conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), showing that at one year nearly 50% of patients' eyes treated with Lucentis and laser therapy improved their visual acuity by 10 letters or more, compared to 28% with laser alone. In addition, the study demonstrated superior gains in visual acuity among Lucentis-treated patients up to two years.
Lucentis was generally well tolerated in clinical studies, either when given as monotherapy or when combined with laser treatment. Its safety profile was consistent with that previously reported in large controlled clinical trials, and in rigorous monitoring since Lucentis was first approved for wet age-related macular degeneration (AMD). Lucentis is currently licensed in more than 85 countries for the treatment of wet AMD.
Diabetic macular edema (DME) is a consequence of diabetic retinopathy - the most common diabetic eye complication, characterized by changes in the blood vessels of the retina - to the light-sensitive layer at the back of the eye. In patients with DME, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DME can lead to significant visual impairment. Visual impairment due to DME affects approximately 1-3% of patients with diabetes, and DME is a leading cause of blindness in the working-age population in most developed countries.
Lucentis offers an entirely new pharmacological approach to treatment compared to the current standard of care for DME that involves the use of laser burns to stop the capillary leakage and to reduce swelling. Lucentis is an antibody fragment that is injected into the eye and acts by neutralizing vascular endothelial growth factor (VEGF), a protein that is known to increase vascular permeability, resulting in capillary leakage and macular edema in patients with diabetes.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States where Lucentis is also approved for the treatment of macular edema following retinal vein occlusion (RVO). In addition, Genentech is conducting two Phase III studies, RISE and RIDE, in patients with diabetic macular edema. The results are expected in 2011. Novartis has exclusive rights in the rest of the world and plans to file in the European Union for approval of Lucentis for the treatment of visual impairment due to macular edema following RVO.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "recommended," "plans," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Lucentis or regarding potential future revenues from Lucentis. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Lucentis to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lucentis will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that Lucentis will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Lucentis could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Saturday, September 18, 2010
Glaucoma eye drops showing some effect against Macular Degeneration
by Dr. Edward Paul
Eye redness was the clue that something was happening to Celia Ramirez's vision. Although she wasn't having trouble driving or doing other tasks, her children urged her to have a checkup. It turned out she was in the early stages of age-related macular degeneration (AMD), a disease that attacks a person's central field of vision.
Mrs. Ramirez, who lives in the Rio Grande Valley, had surgery that successfully controlled her eye pressure, but her central vision continued to degrade.Eye specialist William Sponsel, Ph.D., associate professor and director of research at the Department of Ophthalmology at the University of Texas Health Science Center at San Antonio (UTHSC).Found a treatment with a new combination of drugs.
The miracle is the carbon dioxide, which is crucial for vision. The healthy eye produces enough carbon dioxide to dilate blood vessels around the retina and maintain proper blood flow. The ailing eye does not produce enough. This holds important implications for the treatment of patients with blinding eye diseases such as AMD and glaucoma, which are marked by diminished circulation of blood in the back of the eye. Eye pressure also is a conventional barometer of eye health.
About 60 of 65 patients have seen their vision improve while receiving treatment at UTHSC's teaching hospital, University Hospital. "The patients are receiving combination drug therapy, including agents that trick the eye into retaining more of its carbon dioxide," Dr. Sponsel said. "We have patients with glaucoma and no AMD, patients with AMD and no glaucoma, and patients with both disorders. All appear to demonstrate benefit in the central visual area, regardless of the cause of that visual loss."
The Health Science Center is the first medical center to initiate this combination therapy for patients with central visual loss, Dr. Sponsel said. Considerable research yielded the conclusions that now help patients. "You don't expect these patients to get better, you expect them to get worse," he said. "We have seen dramatic results that bode well for treatment of these disorders in the future."
The researchers measure patients' sensitivity to light on visual function tests. An increase of 10 points represents more than a million-fold increase in actual visual acuity. Mrs. Ramirez's vision in the macula -- the central visual area that enables perception of letters and colors -- was scored as virtually zero on early tests. After the recent treatment, her score is now 24.
The miracle agents are called "carbonic anhydrase inhibitors" (CAI's). Given as eye drops, CAI's reach the back of the eye rapidly and slow the clearance of carbon dioxide while increasing the supply of nutrients. They help dilate blood vessels within and behind the retina, which is the structure that receives, processes and transmits visual images relayed from the brain.
Dr. Sponsel pursued this line of research in an intriguing way -- after discovering that adults who hyperventilated and rapidly blew off their body's carbon dioxide showed decreased vision, eye pressure and circulation in the back of the eye. He was treating subjects one week with a CAI called dorzolamide and the next week with placebo eye drops. During hyperventilation, the subjects on dorzolamide maintained good light sensitivity in their central field of vision, while the same subjects during placebo treatment showed central visual loss. Dr. Sponsel holds two U.S. patents on this work. One valuable aspect of the research is that it proves increased eye pressure is not necessarily the definitive indicator of eye vessel disease.
Eye redness was the clue that something was happening to Celia Ramirez's vision. Although she wasn't having trouble driving or doing other tasks, her children urged her to have a checkup. It turned out she was in the early stages of age-related macular degeneration (AMD), a disease that attacks a person's central field of vision.
Mrs. Ramirez, who lives in the Rio Grande Valley, had surgery that successfully controlled her eye pressure, but her central vision continued to degrade.Eye specialist William Sponsel, Ph.D., associate professor and director of research at the Department of Ophthalmology at the University of Texas Health Science Center at San Antonio (UTHSC).Found a treatment with a new combination of drugs.
The miracle is the carbon dioxide, which is crucial for vision. The healthy eye produces enough carbon dioxide to dilate blood vessels around the retina and maintain proper blood flow. The ailing eye does not produce enough. This holds important implications for the treatment of patients with blinding eye diseases such as AMD and glaucoma, which are marked by diminished circulation of blood in the back of the eye. Eye pressure also is a conventional barometer of eye health.
About 60 of 65 patients have seen their vision improve while receiving treatment at UTHSC's teaching hospital, University Hospital. "The patients are receiving combination drug therapy, including agents that trick the eye into retaining more of its carbon dioxide," Dr. Sponsel said. "We have patients with glaucoma and no AMD, patients with AMD and no glaucoma, and patients with both disorders. All appear to demonstrate benefit in the central visual area, regardless of the cause of that visual loss."
The Health Science Center is the first medical center to initiate this combination therapy for patients with central visual loss, Dr. Sponsel said. Considerable research yielded the conclusions that now help patients. "You don't expect these patients to get better, you expect them to get worse," he said. "We have seen dramatic results that bode well for treatment of these disorders in the future."
The researchers measure patients' sensitivity to light on visual function tests. An increase of 10 points represents more than a million-fold increase in actual visual acuity. Mrs. Ramirez's vision in the macula -- the central visual area that enables perception of letters and colors -- was scored as virtually zero on early tests. After the recent treatment, her score is now 24.
The miracle agents are called "carbonic anhydrase inhibitors" (CAI's). Given as eye drops, CAI's reach the back of the eye rapidly and slow the clearance of carbon dioxide while increasing the supply of nutrients. They help dilate blood vessels within and behind the retina, which is the structure that receives, processes and transmits visual images relayed from the brain.
Dr. Sponsel pursued this line of research in an intriguing way -- after discovering that adults who hyperventilated and rapidly blew off their body's carbon dioxide showed decreased vision, eye pressure and circulation in the back of the eye. He was treating subjects one week with a CAI called dorzolamide and the next week with placebo eye drops. During hyperventilation, the subjects on dorzolamide maintained good light sensitivity in their central field of vision, while the same subjects during placebo treatment showed central visual loss. Dr. Sponsel holds two U.S. patents on this work. One valuable aspect of the research is that it proves increased eye pressure is not necessarily the definitive indicator of eye vessel disease.
Monday, September 13, 2010
Macular Degeneration and your eyesight
You have most probably heard of this very common condition that damages your eyesight as you age. Because this condition affects more elderly people it is often referred to as age-related macular degeneration. Unfortunately there is no cure available for this condition however there are treatments that can help. This blog outlines the latest in research and treatments regarding macular degeneration and aims to help you make the most out of your eyesight in the mean time.
Now macular degeneration as the name implies affects the macula, which is an area right at the back of the eye on a structure that detects light known as the retina. Your macula is the part of the retina that allows you to see things in great detail. In fact many birds have better maculas than us, as they need to see things in great detail from up in the air. The condition of macula degeneration implies that the macula is damaged and as this damage becomes more extensive your eyesight will be affected. There are two types of macula degeneration and they are known as the wet or the dry type, the most common of the two is ‘dry’ maculae degeneration. In this type you get little yellow patches that pop up around your macula and your vision slowly worsens. In ‘wet’ macula degeneration there are tiny blood vessels in the back of your eye that grow and then leak out blood and other fluid. This tends to make ones vision worse more quickly and you should note that dry degeneration can turn into the wet kind.
Those who present with this condition for the most part have difficulty reading, making out fine detail and even have trouble recognizing friends and families faces. After a few years of having this condition things that are in the middle of your vision will begin to look blurred and you may struggle to make things out. After a while the middle of your vision may just appear black and you often cant see anything in this area, this means that you will be unable to see things that are right in front of you. However your peripheral vision will not be affected.
There are things that you can do to cope with this condition as well as medicines that can help. Your doctor may teach you how to make better use of your peripheral vision and tell you that using bright lighting in your home will help you see better. You may also need to make text on the computer screen bigger and use magnifying glasses when reading a book. Most of the medical treatments are aimed at the treatment of wet macular degeneration and in fact there are not many effective treatments for the dry variety. Laser therapy can be used to stop the macular degeneration from getting worse in the sense that these lasers burn away those yellow patches that form around the macular early in the disease course. Also there is no need to worry as laser therapy is not painful and is quite quick, however the evidence supporting this form of treatment is not great at this stage. In fact some research suggests that laser treatment can cause new blood vessels to from on the back of the eye that can make your sight worse.
Mineral and vitamin supplements may be useful in slowing down or stopping macula degeneration from occurring. You should take zinc, vitamin E and C as well as beta-carotene. Remember here that you will need to take them for a long time and in high doses to be affective and remember that these are not without their side effects. Some people find that they have problems with passing urine, others complain of stomach pains and some people notice that their skin turns a little yellow. If this is that case with you then you should stop taking the tablets and visit your doctor.
Wet macular degeneration can be treated with photodynamic laser surgery whereby a dye that is sensitive to light is injected into your bloodstream and then a laser is shone into your eye. The dye that was injected into the blood helps the laser to destroy all of those leaky blood vessels that are damaging your eye. This method has mixed reviews on effectiveness and one should have a good discussion with their doctor regarding the risks and benefits of this procedure before having it done.
There is another type of laser that can be used to destroy the blood vessels in the eye that leak, but this is only affective in a few people with very severe disease. There is a chance with this procedure that the blood vessels will grow back anyway and the laser can sometimes damage the eye. Radiotherapy is another option but lacks suitable research to say whether or not it works and we always worry that radiation may damage other parts of the eye.
There is an injection that you can have in your eyeball called pegaptanib, however for obvious reasons not many people like the idea of this if they can help it. Also you have to have two injections every month and the evidence is not great that it works wonders, although there are some convincing studies. There is another injection called ranibizumab that you get in your eyeball and this also does not have great results but is indicated in people with wet macular degeneration that is getting worse.
So the most important thing is what will happen to you and in this case the outcome is not fantastic. Over many years your vision will gradually get worse and it will be much worse in the centre of your vision than in the peripheries and you are unlikely to go completely blind. Unfortunately we don’t know how quickly things will turn bad and each patient is different, but most people manage to get around even with severe disease as they are able to use their peripheral vision much more effectively.
Now macular degeneration as the name implies affects the macula, which is an area right at the back of the eye on a structure that detects light known as the retina. Your macula is the part of the retina that allows you to see things in great detail. In fact many birds have better maculas than us, as they need to see things in great detail from up in the air. The condition of macula degeneration implies that the macula is damaged and as this damage becomes more extensive your eyesight will be affected. There are two types of macula degeneration and they are known as the wet or the dry type, the most common of the two is ‘dry’ maculae degeneration. In this type you get little yellow patches that pop up around your macula and your vision slowly worsens. In ‘wet’ macula degeneration there are tiny blood vessels in the back of your eye that grow and then leak out blood and other fluid. This tends to make ones vision worse more quickly and you should note that dry degeneration can turn into the wet kind.
Those who present with this condition for the most part have difficulty reading, making out fine detail and even have trouble recognizing friends and families faces. After a few years of having this condition things that are in the middle of your vision will begin to look blurred and you may struggle to make things out. After a while the middle of your vision may just appear black and you often cant see anything in this area, this means that you will be unable to see things that are right in front of you. However your peripheral vision will not be affected.
There are things that you can do to cope with this condition as well as medicines that can help. Your doctor may teach you how to make better use of your peripheral vision and tell you that using bright lighting in your home will help you see better. You may also need to make text on the computer screen bigger and use magnifying glasses when reading a book. Most of the medical treatments are aimed at the treatment of wet macular degeneration and in fact there are not many effective treatments for the dry variety. Laser therapy can be used to stop the macular degeneration from getting worse in the sense that these lasers burn away those yellow patches that form around the macular early in the disease course. Also there is no need to worry as laser therapy is not painful and is quite quick, however the evidence supporting this form of treatment is not great at this stage. In fact some research suggests that laser treatment can cause new blood vessels to from on the back of the eye that can make your sight worse.
Mineral and vitamin supplements may be useful in slowing down or stopping macula degeneration from occurring. You should take zinc, vitamin E and C as well as beta-carotene. Remember here that you will need to take them for a long time and in high doses to be affective and remember that these are not without their side effects. Some people find that they have problems with passing urine, others complain of stomach pains and some people notice that their skin turns a little yellow. If this is that case with you then you should stop taking the tablets and visit your doctor.
Wet macular degeneration can be treated with photodynamic laser surgery whereby a dye that is sensitive to light is injected into your bloodstream and then a laser is shone into your eye. The dye that was injected into the blood helps the laser to destroy all of those leaky blood vessels that are damaging your eye. This method has mixed reviews on effectiveness and one should have a good discussion with their doctor regarding the risks and benefits of this procedure before having it done.
There is another type of laser that can be used to destroy the blood vessels in the eye that leak, but this is only affective in a few people with very severe disease. There is a chance with this procedure that the blood vessels will grow back anyway and the laser can sometimes damage the eye. Radiotherapy is another option but lacks suitable research to say whether or not it works and we always worry that radiation may damage other parts of the eye.
There is an injection that you can have in your eyeball called pegaptanib, however for obvious reasons not many people like the idea of this if they can help it. Also you have to have two injections every month and the evidence is not great that it works wonders, although there are some convincing studies. There is another injection called ranibizumab that you get in your eyeball and this also does not have great results but is indicated in people with wet macular degeneration that is getting worse.
So the most important thing is what will happen to you and in this case the outcome is not fantastic. Over many years your vision will gradually get worse and it will be much worse in the centre of your vision than in the peripheries and you are unlikely to go completely blind. Unfortunately we don’t know how quickly things will turn bad and each patient is different, but most people manage to get around even with severe disease as they are able to use their peripheral vision much more effectively.
Wednesday, August 18, 2010
Drug Research could lead to AMD therapy
By Adrian Galbreth
New drug research may pave the way for more effective treatments of age-related macular degeneration - the leading cause of blindness in the western world.
Those are the claims being made by researchers at Tufts University School of Medicine, who say that a protein known as galectin-3 promotes the growth of new blood vessels, and that targeting the protein can "significantly reduce" angiogenesis.
The findings have been published in the Journal of Experimental Medicine and may lead to treatments for diseases caused by excessive angiogenesis, which include AMD, said Dr Noorjahan Panjwani, who led the project.
She explained: "Our study shows that galectin-3 protein binds to glycans of specific cell-adhesion proteins to activate the signaling pathways that bring about angiogenesis. This improved understanding may provide a more targeted approach to preventing harmful angiogenesis."
Meanwhile, another team of researchers at Tufts have found that that non-viral gene therapy can delay the onset of some forms of eye disease and offer hope to retinal degeneration sufferers.ADNFCR-1853-ID-800028486-ADNFCR
New drug research may pave the way for more effective treatments of age-related macular degeneration - the leading cause of blindness in the western world.
Those are the claims being made by researchers at Tufts University School of Medicine, who say that a protein known as galectin-3 promotes the growth of new blood vessels, and that targeting the protein can "significantly reduce" angiogenesis.
The findings have been published in the Journal of Experimental Medicine and may lead to treatments for diseases caused by excessive angiogenesis, which include AMD, said Dr Noorjahan Panjwani, who led the project.
She explained: "Our study shows that galectin-3 protein binds to glycans of specific cell-adhesion proteins to activate the signaling pathways that bring about angiogenesis. This improved understanding may provide a more targeted approach to preventing harmful angiogenesis."
Meanwhile, another team of researchers at Tufts have found that that non-viral gene therapy can delay the onset of some forms of eye disease and offer hope to retinal degeneration sufferers.ADNFCR-1853-ID-800028486-ADNFCR
Tuesday, July 20, 2010
Stem Cell Transplants Stalled Blindness in Rats
Researchers say putting nerve stem cells from StemCells Inc near the retinas of rats with a form of macular degeneration helped keep the disease from advancing to blindness for several months.Nerve stem cell transplants may help slow the progression of macular degeneration, the most common cause of blindness in the developed world, U.S. researchers said on Monday.
They said putting nerve stem cells from StemCells Inc near the retinas of rats with a form of macular degeneration helped keep the disease from advancing to blindness for several months.
"These cells improve the chemical environment in the back of the eye," said Ray Lund of the Casey Eye Institute at Oregon Health & Science University in Portland, whose findings were presented at the Society for Neuroscience meeting in Chicago.
Lund said the mechanism is not clear, but he suspects that when immature nerve cells are placed near the retina, they produce growth factors that protect the cells from damage by the disease.
"It's basically a chemical pump that is sitting in the right place and producing the right things," Lund said in a telephone interview.
Where normally animals with eye disease lost their vision by three months old, rats that got the transplants kept their vision for at least seven months, he said.
"There is no evidence that they (the transplanted cells) do any damage," Lund said, adding that the animals do not develop tumors, a key worry for stem cell transplants.
The findings raise hope for use of the treatment in humans with a range of diseases in which the retina become damaged, including age-related macular degeneration or AMD, which affects nearly 30 million people worldwide, including 15 million Americans.
People with AMD lose central vision when delicate light-sensing cells of the macula, a region at the center of the retina, become damaged.
In the rats, the researchers transplanted immature nerve cells into the space near the retina. Lund said the same could be done in people with retinal disease.
Dr. Stephen Huhn, head of the Central Nervous System research program at StemCells Inc, said the cells are adult neural stem cells. He said they are multipotent, meaning they can morph into different types of nerve cells.
The company has already tested the treatment in a study of six patients with Batten's disease, a fatal inherited disorder of the nervous system.
"Having a cell that has already entered clinical testing that has been well tolerated at very high doses in the brain gives us a lot of confidence about exploring the same type of strategy in the eye," Huhn said.
Huhn said he thinks the cells may be especially well suited for use in the retina, brain and spinal cord, which are less likely to reject the cells than other parts of the body.
Ultimately, he said the hope is to develop a treatment for the dry form of macular degeneration, which affects around 90 percent of patients diagnosed with AMD. No treatments are available for this form of the disease.
Huhn said treating this form of the disease may prevent some people from developing wet AMD, in which tiny new blood vessels grow between the retina and the back of the eye.
This form of the disease can be treated with modern drugs like Lucentis, from Novartis and Roche's Genentech, and Pfizer's Macugen.
They said putting nerve stem cells from StemCells Inc near the retinas of rats with a form of macular degeneration helped keep the disease from advancing to blindness for several months.
"These cells improve the chemical environment in the back of the eye," said Ray Lund of the Casey Eye Institute at Oregon Health & Science University in Portland, whose findings were presented at the Society for Neuroscience meeting in Chicago.
Lund said the mechanism is not clear, but he suspects that when immature nerve cells are placed near the retina, they produce growth factors that protect the cells from damage by the disease.
"It's basically a chemical pump that is sitting in the right place and producing the right things," Lund said in a telephone interview.
Where normally animals with eye disease lost their vision by three months old, rats that got the transplants kept their vision for at least seven months, he said.
"There is no evidence that they (the transplanted cells) do any damage," Lund said, adding that the animals do not develop tumors, a key worry for stem cell transplants.
The findings raise hope for use of the treatment in humans with a range of diseases in which the retina become damaged, including age-related macular degeneration or AMD, which affects nearly 30 million people worldwide, including 15 million Americans.
People with AMD lose central vision when delicate light-sensing cells of the macula, a region at the center of the retina, become damaged.
In the rats, the researchers transplanted immature nerve cells into the space near the retina. Lund said the same could be done in people with retinal disease.
Dr. Stephen Huhn, head of the Central Nervous System research program at StemCells Inc, said the cells are adult neural stem cells. He said they are multipotent, meaning they can morph into different types of nerve cells.
The company has already tested the treatment in a study of six patients with Batten's disease, a fatal inherited disorder of the nervous system.
"Having a cell that has already entered clinical testing that has been well tolerated at very high doses in the brain gives us a lot of confidence about exploring the same type of strategy in the eye," Huhn said.
Huhn said he thinks the cells may be especially well suited for use in the retina, brain and spinal cord, which are less likely to reject the cells than other parts of the body.
Ultimately, he said the hope is to develop a treatment for the dry form of macular degeneration, which affects around 90 percent of patients diagnosed with AMD. No treatments are available for this form of the disease.
Huhn said treating this form of the disease may prevent some people from developing wet AMD, in which tiny new blood vessels grow between the retina and the back of the eye.
This form of the disease can be treated with modern drugs like Lucentis, from Novartis and Roche's Genentech, and Pfizer's Macugen.
Wednesday, June 30, 2010
Stem cell Therapy to Benefit Blind
Submitted by Jayden Roberts on Tue, 06/29/2010
Italian researchers have reported that about 12 people have regained their sight in a successful experiment conducted with some partly blind and severe eye damage suffering people. This was revealed in a study published online in the New England Journal of Medicine.
This is a remarkable success that will encourage the cell-therapy, which is done by transplanting cells from one’s own body to other parts. It has been claimed that the treatment has proved winning in 82 of 107 eyes. Also, it was partially complete in 14 others eyes. The benefits of the treatment are expected to last till 10 years after the process.
It is also noticeable that one man, who had been blind for more than five decades, have also completely restored his visual capacity. Appreciating the success, Ophthalmologist Ivan Schwab of the University of California praised and congratulated the team.
If the stem cell transplants become popular and are implemented even more, they can also prove helpful for the people who are affected by chemical burns on their corneas from heavy-duty cleansers and other chemicals. This will be a great help for people who have to suffer eyesight loss due to such mishaps.
However, the stem cell approach is not capable to treat optic nerve or macular degeneration, which is caused due to the damage in retina, as the treatment requires a few healthy tissues that can be transplanted.
Italian researchers have reported that about 12 people have regained their sight in a successful experiment conducted with some partly blind and severe eye damage suffering people. This was revealed in a study published online in the New England Journal of Medicine.
This is a remarkable success that will encourage the cell-therapy, which is done by transplanting cells from one’s own body to other parts. It has been claimed that the treatment has proved winning in 82 of 107 eyes. Also, it was partially complete in 14 others eyes. The benefits of the treatment are expected to last till 10 years after the process.
It is also noticeable that one man, who had been blind for more than five decades, have also completely restored his visual capacity. Appreciating the success, Ophthalmologist Ivan Schwab of the University of California praised and congratulated the team.
If the stem cell transplants become popular and are implemented even more, they can also prove helpful for the people who are affected by chemical burns on their corneas from heavy-duty cleansers and other chemicals. This will be a great help for people who have to suffer eyesight loss due to such mishaps.
However, the stem cell approach is not capable to treat optic nerve or macular degeneration, which is caused due to the damage in retina, as the treatment requires a few healthy tissues that can be transplanted.
Thursday, June 10, 2010
Ann Arbor Pharma Firm Testing Zinc For Alzheimer's Treatment
Ann Arbor-based Adeona Pharmaceuticals Inc. (AMEX: AEN) Monday announced the completion of 50 percnet enrollment in Part 2 of its clinical study, "A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2)."
The CopperProof-2 study represents the first controlled clinical study of oral zinc cysteine for the dietary management of Alzheimer's disease and mild cognitive impairment.
Part 2 of the CopperProof-2 study is designed as a 60-subject comparator study. Subjects are randomized on a 50:50 basis to receive either Zinthionein ZC or matching placebo. After 3 and 6 months on clinical trial material, serum measurements of zinc and copper are taken, and any changes in cognitive function using standard clinical tests used in Alzheimer's disease and mild cognitive impairment are recorded.
The completion of 50 percent enrollment follows Adeona's April 14 announcement of positive results from Part 1 of the CopperProof-2 study. Part 1 demonstrated a substantially lower incidence of adverse effects in Alzheimer's disease and mild cognitive impairment subjects (33 percent versus 100 percent) in favor of Zinthionein ZC (containing 150 mg of elemental zinc acetate and 100 mg of cysteine) compared to Galzin (containing either 50 mg or 100 mg of elemental zinc as zinc acetate).
Zinthionein ZC also demonstrated superior serum zinc bioavailability in Alzheimer's disease and mild cognitive impairment subjects compared to both the 50 mg and 100 mg dose levels of Galzin.
"Having pioneered the use of oral zinc therapy in dry age-related macular degeneration, which has now become the standard of care, I believe that Adeona's once-daily, high bioavailability, well-tolerated oral zinc cysteine formulation has the potential to ameliorate the sub-clinical zinc deficiency in Alzheimer's and mild cognitive impairment subjects and substantially grow current markets for oral zinc-based therapies," said David Newsome, M.D., Adeona's senior vice president for research and development.
Added Adeona CEO James S. Kuo, M.D.: "We are pleased to have reached this enrollment milestone on a timely basis and within budget. Along with the recently announced Meda collaboration for flupirtine's development and completion of 50 percent enrollment in the Trimesta multiple sclerosis clinical trial, it represents one of several major transformational changes taking place at the company in the past few months."
Observations by Adeona scientists and other scientists of sub-clinical zinc deficiency in Alzheimer's disease patients plus a body of published literature that chronic elevated copper exposure contributes to the progression of Alzheimer's disease and mild cognitive impairment prompted the present CopperProof-2 clinical study.
Alzheimer's disease can affect the entire brain but it is particularly associated with loss of tissue in the hippocampus, the area in the brain responsible for several functions including short-term memory retention and processing. The hippocampus has one of the highest concentrations of zinc in the brain. Hippocampal zinc is thought to play a role in hundreds of protective enzymes and other systems, including those that detoxify amyloid beta, an abnormally folded peptide that accumulates in aging and is a biomarker for Alzheimer's disease. When cerebrospinal fluid zinc is low, levels of the particularly toxic beta amyloid 42 are elevated.
Hippocampal zinc serves as a neurotransmitter, and also modulates a specific neuroreceptor. If the neuroexcitation goes uncontrolled, there is a derangement of brain tissue function, and possibly neuronal death. By elevating cerebrospinal fluid zinc, the receptor excitation may be better controlled, improving tissue function and thereby acute cognition and tissue survival, as may have been seen in the 1992 study. NMDA-receptor antagonists now available for Alzheimer's, including Namenda and Axura, annually sell an estimated $2.6 billion.
Zinthionein ZC is a once-daily, gastroretentive, sustained-release, oral tablet formulation of zinc and cysteine. Zinc, an essential nutrient, participates as a necessary factor in the activity of over 200 enzymes and the DNA binding capacity of over 400 nuclear regulatory elements. Zinc may also directly participate in antioxidant protection by reducing the susceptibility of sulfhydril groups to damage by oxidative free radicals. Cysteine is an amino acid that has potent anti-oxidant properties and is a necessary component of the copper-zinc-binding protein, metallothionein.
Zinthionein ZC was invented and developed by Adeona scientists to achieve the convenience of once-daily dosing, high oral bioavailability and to minimize gastrointestinal side effects associated with other commercially available, oral zinc products. All of Zinthionein ZC's constituents have GRAS (Generally Regarded as Safe) status. Adeona is developing Zinthionein ZC as a prescription medical food for the dietary management of Alzheimer's disease and mild cognitive impairment. Zinthionein ZC is protected by multiple U.S. and international pending patent applications held by Adeona.
Adeona is a pharmaceutical company developing new medicines for serious central nervous systems diseases. Adeona's primary strategy is to in-license clinical-stage drug candidates that have already demonstrated a certain level of clinical efficacy and develop them to an inflection point in valuation resulting in a significant development and marketing collaboration.
Its other drugs include Trimesta (estriol) is an investigational oral drug for the treatment of relapsing remitting multiple sclerosis, currently in clinical trials, and Effirma (flupirtine), a centrally-acting investigational oral drug for the treatment of fibromyalgia syndrome. Adeona has entered into a potential $17.5 million corporate partnership with Meda AB. As part of the agreement, Meda will assume all future development costs while Adeona is entitled to receive milestone payments and royalties.
The CopperProof-2 study represents the first controlled clinical study of oral zinc cysteine for the dietary management of Alzheimer's disease and mild cognitive impairment.
Part 2 of the CopperProof-2 study is designed as a 60-subject comparator study. Subjects are randomized on a 50:50 basis to receive either Zinthionein ZC or matching placebo. After 3 and 6 months on clinical trial material, serum measurements of zinc and copper are taken, and any changes in cognitive function using standard clinical tests used in Alzheimer's disease and mild cognitive impairment are recorded.
The completion of 50 percent enrollment follows Adeona's April 14 announcement of positive results from Part 1 of the CopperProof-2 study. Part 1 demonstrated a substantially lower incidence of adverse effects in Alzheimer's disease and mild cognitive impairment subjects (33 percent versus 100 percent) in favor of Zinthionein ZC (containing 150 mg of elemental zinc acetate and 100 mg of cysteine) compared to Galzin (containing either 50 mg or 100 mg of elemental zinc as zinc acetate).
Zinthionein ZC also demonstrated superior serum zinc bioavailability in Alzheimer's disease and mild cognitive impairment subjects compared to both the 50 mg and 100 mg dose levels of Galzin.
"Having pioneered the use of oral zinc therapy in dry age-related macular degeneration, which has now become the standard of care, I believe that Adeona's once-daily, high bioavailability, well-tolerated oral zinc cysteine formulation has the potential to ameliorate the sub-clinical zinc deficiency in Alzheimer's and mild cognitive impairment subjects and substantially grow current markets for oral zinc-based therapies," said David Newsome, M.D., Adeona's senior vice president for research and development.
Added Adeona CEO James S. Kuo, M.D.: "We are pleased to have reached this enrollment milestone on a timely basis and within budget. Along with the recently announced Meda collaboration for flupirtine's development and completion of 50 percent enrollment in the Trimesta multiple sclerosis clinical trial, it represents one of several major transformational changes taking place at the company in the past few months."
Observations by Adeona scientists and other scientists of sub-clinical zinc deficiency in Alzheimer's disease patients plus a body of published literature that chronic elevated copper exposure contributes to the progression of Alzheimer's disease and mild cognitive impairment prompted the present CopperProof-2 clinical study.
Alzheimer's disease can affect the entire brain but it is particularly associated with loss of tissue in the hippocampus, the area in the brain responsible for several functions including short-term memory retention and processing. The hippocampus has one of the highest concentrations of zinc in the brain. Hippocampal zinc is thought to play a role in hundreds of protective enzymes and other systems, including those that detoxify amyloid beta, an abnormally folded peptide that accumulates in aging and is a biomarker for Alzheimer's disease. When cerebrospinal fluid zinc is low, levels of the particularly toxic beta amyloid 42 are elevated.
Hippocampal zinc serves as a neurotransmitter, and also modulates a specific neuroreceptor. If the neuroexcitation goes uncontrolled, there is a derangement of brain tissue function, and possibly neuronal death. By elevating cerebrospinal fluid zinc, the receptor excitation may be better controlled, improving tissue function and thereby acute cognition and tissue survival, as may have been seen in the 1992 study. NMDA-receptor antagonists now available for Alzheimer's, including Namenda and Axura, annually sell an estimated $2.6 billion.
Zinthionein ZC is a once-daily, gastroretentive, sustained-release, oral tablet formulation of zinc and cysteine. Zinc, an essential nutrient, participates as a necessary factor in the activity of over 200 enzymes and the DNA binding capacity of over 400 nuclear regulatory elements. Zinc may also directly participate in antioxidant protection by reducing the susceptibility of sulfhydril groups to damage by oxidative free radicals. Cysteine is an amino acid that has potent anti-oxidant properties and is a necessary component of the copper-zinc-binding protein, metallothionein.
Zinthionein ZC was invented and developed by Adeona scientists to achieve the convenience of once-daily dosing, high oral bioavailability and to minimize gastrointestinal side effects associated with other commercially available, oral zinc products. All of Zinthionein ZC's constituents have GRAS (Generally Regarded as Safe) status. Adeona is developing Zinthionein ZC as a prescription medical food for the dietary management of Alzheimer's disease and mild cognitive impairment. Zinthionein ZC is protected by multiple U.S. and international pending patent applications held by Adeona.
Adeona is a pharmaceutical company developing new medicines for serious central nervous systems diseases. Adeona's primary strategy is to in-license clinical-stage drug candidates that have already demonstrated a certain level of clinical efficacy and develop them to an inflection point in valuation resulting in a significant development and marketing collaboration.
Its other drugs include Trimesta (estriol) is an investigational oral drug for the treatment of relapsing remitting multiple sclerosis, currently in clinical trials, and Effirma (flupirtine), a centrally-acting investigational oral drug for the treatment of fibromyalgia syndrome. Adeona has entered into a potential $17.5 million corporate partnership with Meda AB. As part of the agreement, Meda will assume all future development costs while Adeona is entitled to receive milestone payments and royalties.
Saturday, June 6, 2009
Regular eye exams are ‘best check’for eye disease
By Sally Rummel
Chances are that sometime in your life, you will experience some of the symptoms of several common diseases of the eye. Thanks to huge advancements in technology, remarkable improvement can be experienced for most patients with cataracts, glaucoma and macular degeneration.
“So much more can be done today to treat eye disease,” said Doran Kasper, O.D., whose optometry practice has been located in Fenton for almost four decades.
Cataracts
A cataract is a clouding of the eye’s natural lens, which lies behind the iris and the pupil. The lens works much like a camera lens, focusing light onto the retina at the back of the eye. The lens also adjusts the eye’s focus, providing clear vision, both up close and far away.
*
The lens is mostly made of water and protein. The protein is arranged in a precise way that keeps the lens clear and lets light pass through it.
As people age, some of the protein may clump together and start to cloud a small area of the lens. This is a cataract, and over time, it may grow larger and cloud more of the lens, making it harder to see.
How do I know if I have cataracts?
A cataract starts out small, and at first has little effect on one’s vision. Vision may be slightly blurred, like looking through a cloudy piece of glass.
“Around the age of 50, the lens inside peoples’ eyes become cloudy enough that I can see it with my slit-lamp microscope which I use with my eye examination,” said Dr. Juan Alvarado from the Fenton Vision Center. “Eye doctors generally don’t diagnose ‘clinical’ cataracts until the cloudiness becomes vision impairing.”
A cataract may make light from the sun or a lamp seem too bright or glaring. Night drivers may notice that the oncoming headlights cause more glare than before. Colors may not appear as bright as they once did.
If you think you have a cataract, see an eye doctor for an exam to find out for sure.
When cataract surgery becomes the best option, doctors at the Michigan Eye Institute say that there are fewer than half a dozen vision practices in the state of Michigan that offer their level of experience in cataract surgery.
“We don’t use shots, needles or stitches during this 18-minute surgery,” said Dr. Bernard Tekiele. “Patients actually leave our center after surgery without an eye patch. They can expect a quick recovery with minimal limitations.
Glaucoma
Glaucoma is a category of eye disorders associated with a dangerous build-up of internal eye pressure, which can damage the eye’s optic nerve that transmits visual information to the brain.
If left untreated, patients will notice decreased peripheral vision and it can lead to blindness. In fact, glaucoma creates at least some vision loss in more than half of the approximately 2.5 million Americans who have the disease. It is the second leading cause of blindness.
Glaucoma typically causes no pain and no symptoms, often progressing without detection until the optic nerve has already been irreversibly damaged, with varying degrees of permanent vision loss.
There is no cure, but proper treatment can dramatically slow or temporarily halt its progress. Glaucoma can be treated with either medication or surgery — both aimed at lowering intraocular pressure (IOP), or pressure within the eye.
In the U.S., medications are usually the first line of glaucoma treatment. If this fails, then glaucoma surgery is the next treatment considered.
Macular Degeneration
Macular Degeneration (MD) is the most common cause of irreversible loss of central vision for senior citizens, according to the Fenton Vision Center.
The macula is located in the center of the retina — the micro-thin membrane that lines the back inside of the eye. The retina has millions of light-sensitive nerve cells that capture images focused on the retina, according to Alvarado. These captured images are transmitted to the brain by the optic nerve.
Any damage to the macula results in some loss of central vision.
There are two forms of MD:
The dry form affects about 90 percent of patients diagnosed with MD. It’s usually a gradual process that develops over the years and may affect only one eye. A person may notice more difficulty seeing with one eye than the other, a distortion of straight lines or small dark spots in the field of vision.
The wet form is less common, but has more devastating vision loss. It occurs when tiny blood vessels in the micro-thin layer of tissue beneath the retina begin to degenerate, causing tiny leaks. This can cause swelling and breaks or lesions in the retina, damaging the retina’s light-sensitive nerve cells.
“There is no cure for macular degeneration, but there are ways to help cure or delay its progression,” said doctors at the Michigan Eye Institute. Patients who have the disease or a relative with the disease are encouraged to eat a variety of green leafy vegetables, take a multi-vitamin containing lutein, and fish oil or flaxseed supplements for omega-3 fatty acids.
According to Fenton Vision Center, lasers have been used to treat the wet form of MD, but the best results come from finding the cause, and treat that to slow its progression. “We offer dialation to everyone regardless of age for all diseases,” said Alvarado. “A thorough annual eye exam is the best protection for your vision.”
Chances are that sometime in your life, you will experience some of the symptoms of several common diseases of the eye. Thanks to huge advancements in technology, remarkable improvement can be experienced for most patients with cataracts, glaucoma and macular degeneration.
“So much more can be done today to treat eye disease,” said Doran Kasper, O.D., whose optometry practice has been located in Fenton for almost four decades.
Cataracts
A cataract is a clouding of the eye’s natural lens, which lies behind the iris and the pupil. The lens works much like a camera lens, focusing light onto the retina at the back of the eye. The lens also adjusts the eye’s focus, providing clear vision, both up close and far away.
*
The lens is mostly made of water and protein. The protein is arranged in a precise way that keeps the lens clear and lets light pass through it.
As people age, some of the protein may clump together and start to cloud a small area of the lens. This is a cataract, and over time, it may grow larger and cloud more of the lens, making it harder to see.
How do I know if I have cataracts?
A cataract starts out small, and at first has little effect on one’s vision. Vision may be slightly blurred, like looking through a cloudy piece of glass.
“Around the age of 50, the lens inside peoples’ eyes become cloudy enough that I can see it with my slit-lamp microscope which I use with my eye examination,” said Dr. Juan Alvarado from the Fenton Vision Center. “Eye doctors generally don’t diagnose ‘clinical’ cataracts until the cloudiness becomes vision impairing.”
A cataract may make light from the sun or a lamp seem too bright or glaring. Night drivers may notice that the oncoming headlights cause more glare than before. Colors may not appear as bright as they once did.
If you think you have a cataract, see an eye doctor for an exam to find out for sure.
When cataract surgery becomes the best option, doctors at the Michigan Eye Institute say that there are fewer than half a dozen vision practices in the state of Michigan that offer their level of experience in cataract surgery.
“We don’t use shots, needles or stitches during this 18-minute surgery,” said Dr. Bernard Tekiele. “Patients actually leave our center after surgery without an eye patch. They can expect a quick recovery with minimal limitations.
Glaucoma
Glaucoma is a category of eye disorders associated with a dangerous build-up of internal eye pressure, which can damage the eye’s optic nerve that transmits visual information to the brain.
If left untreated, patients will notice decreased peripheral vision and it can lead to blindness. In fact, glaucoma creates at least some vision loss in more than half of the approximately 2.5 million Americans who have the disease. It is the second leading cause of blindness.
Glaucoma typically causes no pain and no symptoms, often progressing without detection until the optic nerve has already been irreversibly damaged, with varying degrees of permanent vision loss.
There is no cure, but proper treatment can dramatically slow or temporarily halt its progress. Glaucoma can be treated with either medication or surgery — both aimed at lowering intraocular pressure (IOP), or pressure within the eye.
In the U.S., medications are usually the first line of glaucoma treatment. If this fails, then glaucoma surgery is the next treatment considered.
Macular Degeneration
Macular Degeneration (MD) is the most common cause of irreversible loss of central vision for senior citizens, according to the Fenton Vision Center.
The macula is located in the center of the retina — the micro-thin membrane that lines the back inside of the eye. The retina has millions of light-sensitive nerve cells that capture images focused on the retina, according to Alvarado. These captured images are transmitted to the brain by the optic nerve.
Any damage to the macula results in some loss of central vision.
There are two forms of MD:
The dry form affects about 90 percent of patients diagnosed with MD. It’s usually a gradual process that develops over the years and may affect only one eye. A person may notice more difficulty seeing with one eye than the other, a distortion of straight lines or small dark spots in the field of vision.
The wet form is less common, but has more devastating vision loss. It occurs when tiny blood vessels in the micro-thin layer of tissue beneath the retina begin to degenerate, causing tiny leaks. This can cause swelling and breaks or lesions in the retina, damaging the retina’s light-sensitive nerve cells.
“There is no cure for macular degeneration, but there are ways to help cure or delay its progression,” said doctors at the Michigan Eye Institute. Patients who have the disease or a relative with the disease are encouraged to eat a variety of green leafy vegetables, take a multi-vitamin containing lutein, and fish oil or flaxseed supplements for omega-3 fatty acids.
According to Fenton Vision Center, lasers have been used to treat the wet form of MD, but the best results come from finding the cause, and treat that to slow its progression. “We offer dialation to everyone regardless of age for all diseases,” said Alvarado. “A thorough annual eye exam is the best protection for your vision.”
Sunday, May 10, 2009
Foundation Fighting Blindness’ National Neurovision Research Institute Heralds Collaboration for Gene Therapy Advancements
Foundation Fighting Blindness’ National Neurovision Research Institute Heralds Collaboration for Gene Therapy Advancements
OWINGS MILLS, Md.--(BUSINESS WIRE)--The National Neurovision Research Institute (NNRI), the Foundation Fighting Blindness’ clinical trial support organization, announced today that one of its key partners, biopharmaceutical company Oxford BioMedica, has established a collaboration with sanofi-aventis, a major international pharmaceutical company, to develop and commercialize gene therapy treatments for vision-robbing retinal degenerative diseases that affect tens of millions of people around the world.
The collaboration will significantly bolster the development of the following gene therapy products: StarGen™ for the treatment of Stargardt disease, a form of early-onset macular degeneration; UshStat™ for the treatment of Usher syndrome, the leading cause of deaf-blindness; RetinoStat® for the treatment of age-related macular degeneration, the leading cause vision loss in people 55 and older in developed countries; and EncorStat™ for corneal graft rejection.
The development of treatments for these and other retinal degenerative diseases is a key goal of the National Neurovision Research Institute and is the basis for its partnership with Oxford BioMedica. In 2006, Paul and Diane Manning, with the National Neurovision Research Institute, established a partnership with Oxford BioMedica to advance gene therapies for these and other related retinal degenerative diseases.
“The investment from sanofi-aventis is a wonderful boost for the development of Oxford BioMedica’s gene therapy products and will greatly enhance our ability to move these emerging treatments into and through the clinical trial process,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “This collaboration affirms the great potential for gene therapy to treat and cure a number of retinal degenerative diseases including Stargardt disease and Usher syndrome that, as rare diseases, often do not receive the attention or investment necessary to bring about promising treatments.”
“An important goal of the Foundation, through NNRI, is to attract investment from large pharmaceutical companies for the development and production of treatments for inherited retinal disease,” says Morton Goldberg, M.D., chairman of the board of NNRI. “The NNRI-Oxford partnership is an excellent model of how NNRI collaborations can accelerate the translation of laboratory-based research into clinical trials, ultimately getting successful treatments for rare diseases like inherited retinal degenerations to the market and out to the people who need them.”
Based on the agreement, Oxford BioMedica will receive approximately €43 million ($56 million) from sanofi-aventis over a three-year period. Oxford BioMedica is eligible to receive additional fees if development efforts are successful.
The treatments will utilize Oxford BioMedica’s LentiVector® gene delivery technology to deliver healthy vision-saving genes to the retina.
About Foundation Fighting Blindness
The Foundation Fighting Blindness is the largest source of non-governmental funding for retinal degenerative disease research in the world. The urgent mission of the Foundation Fighting Blindness is to drive the research that will provide preventions, treatments and cures for people affected by retinitis pigmentosa, macular degeneration, Usher syndrome, and the entire spectrum of retinal degenerative diseases. The Foundation has invested over $140 million to provide seed money for scientific research of diseases of the retina, which cause blindness. Further information is available at www.FightBlindness.org.
About National Neurovision Research Institute (NNRI)
NNRI is a recently-established non-profit support organization of the Foundation Fighting Blindness (FFB), the leading non-government funding source for inherited orphan retinal degeneration research. The mission of NNRI is to accelerate the translation of laboratory based research into clinical trials for treatments and cures of retinal degenerative diseases. It is a medical research institute that obtains support from government agencies, corporations and private foundations. It may also receive royalties or licensing fees from the drug discovery processes and commercialization of new therapies. Further information is available at www.nnri.info.
OWINGS MILLS, Md.--(BUSINESS WIRE)--The National Neurovision Research Institute (NNRI), the Foundation Fighting Blindness’ clinical trial support organization, announced today that one of its key partners, biopharmaceutical company Oxford BioMedica, has established a collaboration with sanofi-aventis, a major international pharmaceutical company, to develop and commercialize gene therapy treatments for vision-robbing retinal degenerative diseases that affect tens of millions of people around the world.
The collaboration will significantly bolster the development of the following gene therapy products: StarGen™ for the treatment of Stargardt disease, a form of early-onset macular degeneration; UshStat™ for the treatment of Usher syndrome, the leading cause of deaf-blindness; RetinoStat® for the treatment of age-related macular degeneration, the leading cause vision loss in people 55 and older in developed countries; and EncorStat™ for corneal graft rejection.
The development of treatments for these and other retinal degenerative diseases is a key goal of the National Neurovision Research Institute and is the basis for its partnership with Oxford BioMedica. In 2006, Paul and Diane Manning, with the National Neurovision Research Institute, established a partnership with Oxford BioMedica to advance gene therapies for these and other related retinal degenerative diseases.
“The investment from sanofi-aventis is a wonderful boost for the development of Oxford BioMedica’s gene therapy products and will greatly enhance our ability to move these emerging treatments into and through the clinical trial process,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “This collaboration affirms the great potential for gene therapy to treat and cure a number of retinal degenerative diseases including Stargardt disease and Usher syndrome that, as rare diseases, often do not receive the attention or investment necessary to bring about promising treatments.”
“An important goal of the Foundation, through NNRI, is to attract investment from large pharmaceutical companies for the development and production of treatments for inherited retinal disease,” says Morton Goldberg, M.D., chairman of the board of NNRI. “The NNRI-Oxford partnership is an excellent model of how NNRI collaborations can accelerate the translation of laboratory-based research into clinical trials, ultimately getting successful treatments for rare diseases like inherited retinal degenerations to the market and out to the people who need them.”
Based on the agreement, Oxford BioMedica will receive approximately €43 million ($56 million) from sanofi-aventis over a three-year period. Oxford BioMedica is eligible to receive additional fees if development efforts are successful.
The treatments will utilize Oxford BioMedica’s LentiVector® gene delivery technology to deliver healthy vision-saving genes to the retina.
About Foundation Fighting Blindness
The Foundation Fighting Blindness is the largest source of non-governmental funding for retinal degenerative disease research in the world. The urgent mission of the Foundation Fighting Blindness is to drive the research that will provide preventions, treatments and cures for people affected by retinitis pigmentosa, macular degeneration, Usher syndrome, and the entire spectrum of retinal degenerative diseases. The Foundation has invested over $140 million to provide seed money for scientific research of diseases of the retina, which cause blindness. Further information is available at www.FightBlindness.org.
About National Neurovision Research Institute (NNRI)
NNRI is a recently-established non-profit support organization of the Foundation Fighting Blindness (FFB), the leading non-government funding source for inherited orphan retinal degeneration research. The mission of NNRI is to accelerate the translation of laboratory based research into clinical trials for treatments and cures of retinal degenerative diseases. It is a medical research institute that obtains support from government agencies, corporations and private foundations. It may also receive royalties or licensing fees from the drug discovery processes and commercialization of new therapies. Further information is available at www.nnri.info.
Sunday, May 3, 2009
Tufts Medical Center Researchers Create a New Predictive Model for Age-related Macular Degeneration (AMD)
Tufts Medical Center Researchers Create a New Predictive Model for Age-related Macular Degeneration (AMD)
BOSTON, April 23 /PRNewswire-USNewswire/ -- Researchers at Tufts Medical Center have created a formula for predicting how likely it is that individuals with certain genetic profiles and lifestyle behaviors will develop advanced Age-related Macular Degeneration (AMD), a potentially blinding condition that currently affects an estimated two million older Americans and is increasing dramatically as the population ages.
The study, led by Johanna M. Seddon, MD, ScM, Professor of Ophthalmology at Tufts University School of Medicine and Director of the Ophthalmic Epidemiology and Genetics Service at Tufts Medical Center, evaluated six genotypes that either increase or decrease risk for AMD. In addition to age, sex, and education, she also incorporated smoking status and higher body mass index (BMI) which increase risk of AMD, and supplementation with a high-dose formulation of antioxidants and zinc which delays progression of the disease. Using their new algorithm, Dr. Seddon and her colleagues determined that several genotypes plus the lifestyle factors can predict progression to the advanced forms of AMD with a certainty as high as 83%. The paper, "Prediction model for prevalence and incidence of advanced age-related macular degeneration based on genetic, demographic, and environmental variables" was published in the May issue of the journal Investigative Ophthalmology & Visual Science.
Their research also shows that although AMD has a strong genetic component, healthy behaviors can modify your genetic susceptibility. For example, among individuals with one genotype, the homozygous C3 risk genotype, the likelihood of progression to the advanced form of AMD increased from about three-fold for nonsmokers to nearly 10-fold for smokers.
"Our algorithm could help with the selection of study participants for treatment trials and could one day enable doctors to choose the most efficacious treatment for individual patients," Dr. Seddon said. "It also gives any older person concerned about AMD, or any patient with early stages or a family history of AMD, even more incentive to avoid risk factors such as smoking and excessive weight."
The study included 1,446 individuals from the Age-Related Eye Disease Study who had 6.3 years of follow-up, of which 279 progressed to the advanced stages of AMD.
About Tufts Medical Center
Tufts Medical Center is a not-for-profit, 439-bed academic medical center that is home to both a full-service hospital for adults and Floating Hospital for Children.
BOSTON, April 23 /PRNewswire-USNewswire/ -- Researchers at Tufts Medical Center have created a formula for predicting how likely it is that individuals with certain genetic profiles and lifestyle behaviors will develop advanced Age-related Macular Degeneration (AMD), a potentially blinding condition that currently affects an estimated two million older Americans and is increasing dramatically as the population ages.
The study, led by Johanna M. Seddon, MD, ScM, Professor of Ophthalmology at Tufts University School of Medicine and Director of the Ophthalmic Epidemiology and Genetics Service at Tufts Medical Center, evaluated six genotypes that either increase or decrease risk for AMD. In addition to age, sex, and education, she also incorporated smoking status and higher body mass index (BMI) which increase risk of AMD, and supplementation with a high-dose formulation of antioxidants and zinc which delays progression of the disease. Using their new algorithm, Dr. Seddon and her colleagues determined that several genotypes plus the lifestyle factors can predict progression to the advanced forms of AMD with a certainty as high as 83%. The paper, "Prediction model for prevalence and incidence of advanced age-related macular degeneration based on genetic, demographic, and environmental variables" was published in the May issue of the journal Investigative Ophthalmology & Visual Science.
Their research also shows that although AMD has a strong genetic component, healthy behaviors can modify your genetic susceptibility. For example, among individuals with one genotype, the homozygous C3 risk genotype, the likelihood of progression to the advanced form of AMD increased from about three-fold for nonsmokers to nearly 10-fold for smokers.
"Our algorithm could help with the selection of study participants for treatment trials and could one day enable doctors to choose the most efficacious treatment for individual patients," Dr. Seddon said. "It also gives any older person concerned about AMD, or any patient with early stages or a family history of AMD, even more incentive to avoid risk factors such as smoking and excessive weight."
The study included 1,446 individuals from the Age-Related Eye Disease Study who had 6.3 years of follow-up, of which 279 progressed to the advanced stages of AMD.
About Tufts Medical Center
Tufts Medical Center is a not-for-profit, 439-bed academic medical center that is home to both a full-service hospital for adults and Floating Hospital for Children.
Sunday, April 26, 2009
Othera's Eye Drop to Cure ARMD Seems Promising But Too Early to Tell
Othera's Eye Drop to Cure ARMD Seems Promising But Too Early to Tell
April 16, 2009
Implications
An eye drop that stabilizes the most common form of AMD is encouraging. The ability for an eye drop to be effective is curious. Historically it has been difficult to get any medication effectively delivered to the retina via topical medications. The development of geographic atrophy is very, very slow and it is surprising that a positive trend can be noted in such a short time.
Analysis
Macular degeneration is on the rise. It is estimated that the prevalence of the disease will double in the next 40 years. Macular degeneration is often broken down into "wet" and "dry." The exudative, or wet form, involves choroidal neovascularization and is treated with anti-VEGF treatments such as Avastin, Macugen or Lucentis.
The dry form is the more common form affecting about 90% of all those afflicted with macular degeneration. The most severe of these is geographic atrophy (GA). It is a slowly progressive disease causing damage and loss of the vital underlying RPE cells. It usually takes years for patients to notice a change to their vision.
The news release describes a treatment that may be potentially helpful to most patients that are afflicted with macular degeneration. A simple eye drop to treat this disease is very intriguing. Presently, most treatments for wet macular degeneration involve direct intraocular injection of a substance as topical therapy has traditionally yielded poor drug levels reaching the retinal surface.
Clinically, it has been my experience that the disease progresses very slowly and to notice a change, for better or worse, in such a short time of two years is surprising.
Randall V. Wong, M.D.
April 16, 2009
Implications
An eye drop that stabilizes the most common form of AMD is encouraging. The ability for an eye drop to be effective is curious. Historically it has been difficult to get any medication effectively delivered to the retina via topical medications. The development of geographic atrophy is very, very slow and it is surprising that a positive trend can be noted in such a short time.
Analysis
Macular degeneration is on the rise. It is estimated that the prevalence of the disease will double in the next 40 years. Macular degeneration is often broken down into "wet" and "dry." The exudative, or wet form, involves choroidal neovascularization and is treated with anti-VEGF treatments such as Avastin, Macugen or Lucentis.
The dry form is the more common form affecting about 90% of all those afflicted with macular degeneration. The most severe of these is geographic atrophy (GA). It is a slowly progressive disease causing damage and loss of the vital underlying RPE cells. It usually takes years for patients to notice a change to their vision.
The news release describes a treatment that may be potentially helpful to most patients that are afflicted with macular degeneration. A simple eye drop to treat this disease is very intriguing. Presently, most treatments for wet macular degeneration involve direct intraocular injection of a substance as topical therapy has traditionally yielded poor drug levels reaching the retinal surface.
Clinically, it has been my experience that the disease progresses very slowly and to notice a change, for better or worse, in such a short time of two years is surprising.
Randall V. Wong, M.D.
Sunday, April 19, 2009
Vigorous Exercise May Help Prevent Vision Loss
Vigorous exercise may help prevent vision loss, according to a pair of studies from the U.S. Department of Energy's Lawrence Berkeley National Laboratory. The studies tracked approximately 31,000 runners for more than seven years, and found that running reduced the risk of both cataracts and age-related macular degeneration.
The research, which is among the first to suggest that vigorous exercise may help prevent vision loss, offers hope for people seeking to fend off the onset of eye disease.
"In addition to obtaining regular eye exams, people can take a more active role in preserving their vision," says Paul Williams, an epidemiologist in Berkeley Lab's Life Sciences Division who conducted the research. "The studies suggest that people can perhaps lessen their risk for cataracts and macular degeneration by taking part in a fitness regimen that includes vigorous exercise."
A cataract, which is a cloudy opacity of the eye lens, is the leading cause of blindness. More than one-half of people in the U.S. over the age of 65 suffer from some form of cataracts. Macular degeneration, which is damage to the retina, is the leading cause of irreversible vision loss in older white Americans, affecting 28 percent of people aged 75 and older.
Macular degeneration gradually destroys sharp, central vision. Macular degeneration affects the macula, the part of the eye that allows you to see fine detail. The macula is located in the center of the retina, the light-sensitive tissue at the back of the eye. The retina instantly converts light, or an image, into electrical impulses. The retina then sends these impulses, or nerve signals, to the brain. Macular degeneration causes no pain.
The diseases have several known risk factors, such as sunlight exposure and diabetes in the case of cataracts, but few interventions. Now, it appears that vigorous cardiovascular exercise may be one way to derail the diseases.
To conduct the research, Williams analyzed data collected in the National Runners' Health Study, which he established in 1991 to determine the health benefits of running.
In this case, he followed approximately 29,000 male runners and 12,000 female runners for more than seven years. Of these people, 733 men reported being diagnosed with cataracts on a questionnaire filled out at the end of the study. Too few women reported cataracts to track.
Men who ran more than 5.7 miles per day had a 35 percent lower risk of developing cataracts than men who ran less than 1.4 miles per day. The study also analyzed men's 10-kilometer race performances, which is a good indicator of overall fitness. The fittest men boasted one-half the risk of developing cataracts compared to the least-fit men.
A second study found that running appeared to reduce the risk of macular degeneration. In the study, 152 men and women reported being diagnosed with the disease. Compared to people who ran less than 1.2 miles per day, people who averaged between 1.2 and 2.4 miles per day had a 19 percent lower risk for the disease, and people who ran more than 2.4 miles per day had between 42 percent and 54 percent lower risk of macular degeneration.
"These findings are compelling because of the large size of the study, and the fact that we are looking at something that is fairly well defined: vigorous exercise, as opposed to more moderate exercise," says Williams.
Most of the runners in the study exceeded the current public health recommendations for physical activity, which is at least 30 minutes of moderate-intensity activities such as brisk walking five days a week, or smaller doses of more vigorous exercise such as running. It is unclear whether people might also lower their risk for cataracts and age-related macular degeneration by walking.
"We know there are important health benefits to walking, including lowering heart disease risk," says Williams. "It is quite likely that the studies' results might apply to a lesser extent to smaller doses of more moderate exercise."
Williams also adds that further research is needed to explore why there is a link between vigorous exercise and a decreased risk for eye disease.
"We know some of the physiological benefits of exercise, and we know about the physiological background of these diseases, so we need to better understand where there's an overlap," says Williams.
The research, which is among the first to suggest that vigorous exercise may help prevent vision loss, offers hope for people seeking to fend off the onset of eye disease.
"In addition to obtaining regular eye exams, people can take a more active role in preserving their vision," says Paul Williams, an epidemiologist in Berkeley Lab's Life Sciences Division who conducted the research. "The studies suggest that people can perhaps lessen their risk for cataracts and macular degeneration by taking part in a fitness regimen that includes vigorous exercise."
A cataract, which is a cloudy opacity of the eye lens, is the leading cause of blindness. More than one-half of people in the U.S. over the age of 65 suffer from some form of cataracts. Macular degeneration, which is damage to the retina, is the leading cause of irreversible vision loss in older white Americans, affecting 28 percent of people aged 75 and older.
Macular degeneration gradually destroys sharp, central vision. Macular degeneration affects the macula, the part of the eye that allows you to see fine detail. The macula is located in the center of the retina, the light-sensitive tissue at the back of the eye. The retina instantly converts light, or an image, into electrical impulses. The retina then sends these impulses, or nerve signals, to the brain. Macular degeneration causes no pain.
The diseases have several known risk factors, such as sunlight exposure and diabetes in the case of cataracts, but few interventions. Now, it appears that vigorous cardiovascular exercise may be one way to derail the diseases.
To conduct the research, Williams analyzed data collected in the National Runners' Health Study, which he established in 1991 to determine the health benefits of running.
In this case, he followed approximately 29,000 male runners and 12,000 female runners for more than seven years. Of these people, 733 men reported being diagnosed with cataracts on a questionnaire filled out at the end of the study. Too few women reported cataracts to track.
Men who ran more than 5.7 miles per day had a 35 percent lower risk of developing cataracts than men who ran less than 1.4 miles per day. The study also analyzed men's 10-kilometer race performances, which is a good indicator of overall fitness. The fittest men boasted one-half the risk of developing cataracts compared to the least-fit men.
A second study found that running appeared to reduce the risk of macular degeneration. In the study, 152 men and women reported being diagnosed with the disease. Compared to people who ran less than 1.2 miles per day, people who averaged between 1.2 and 2.4 miles per day had a 19 percent lower risk for the disease, and people who ran more than 2.4 miles per day had between 42 percent and 54 percent lower risk of macular degeneration.
"These findings are compelling because of the large size of the study, and the fact that we are looking at something that is fairly well defined: vigorous exercise, as opposed to more moderate exercise," says Williams.
Most of the runners in the study exceeded the current public health recommendations for physical activity, which is at least 30 minutes of moderate-intensity activities such as brisk walking five days a week, or smaller doses of more vigorous exercise such as running. It is unclear whether people might also lower their risk for cataracts and age-related macular degeneration by walking.
"We know there are important health benefits to walking, including lowering heart disease risk," says Williams. "It is quite likely that the studies' results might apply to a lesser extent to smaller doses of more moderate exercise."
Williams also adds that further research is needed to explore why there is a link between vigorous exercise and a decreased risk for eye disease.
"We know some of the physiological benefits of exercise, and we know about the physiological background of these diseases, so we need to better understand where there's an overlap," says Williams.
Saturday, April 11, 2009
Implantable Eye Telescope Brings Sight Back To The Blind
Implantable Eye Telescope Brings Sight Back To The Blind
Written on April 10, 2009 – 10:45 am | by Drew Halley |
imt_photoFor the millions of people who suffer from age-related eye degeneration, restoring sight to the blind might sound less like reality and more like a miracle. But thanks to an incredible miniature eye implant that works to restore central vision, the future’s looking bright.
The macula is a part of the retina responsible for highly detailed central vision. It contains a high density of cone cells, which allow us to perceive fine detail and quick movement in our environment - for healthy individuals, that is. Patients suffering from age-related macular degeneration (AMD) partially or totally lose this functionality, resulting in a “blind spot” where their focal point normally rests. This can make it difficult to read, recognize faces, or even watch television… until now.
The Implantable Miniature Telescope, or IMT, is a tiny prosthetic implanted into the patient’s eye. Rather than directing light to the damaged macula, the telescope projects the image onto a broader surface of the retina that surrounds the macula. In this way, visual information is redirected to healthy rods and cones, and can be processed in the brain as central vision.
Both central and peripheral vision are important functions of the visual system. Because of this, the IMT is only implanted into one eye of patients with macular degeneration. One eye continues to process peripheral vision normally (which is better suited for low-light vision, for example), while the implanted eye restores the central vision that was previously impaired. This allows individuals to again experience the full range of visual stimuli so necessary to everyday life. And because the implant is embedded in the iris, it goes unnoticed to others.
A simulation of impaired vision caused by AMD
Macular degeneration primarily effects older adults, and is the leading cause of blindness in the elderly. Nearly 15 million people suffer from AMD in the United States alone. Approximately 10% of adults between the ages of 66 and 74 suffer from AMD, a figure that jumps to 30% between the ages of 75 and 85, according to The Eye Digest.
“In an end-stage AMD population, the indicated improvements in this study are substantial compared to risks of surgery,” said study coauthor R. Doyle Stulting, M.D., Ph.D. “For patients with this level of visual impairment, the ability to be less dependent on others and to reclaim even a few of the activities they once enjoyed could make a real difference in their lives.”
The IMT was developed by VisionCare Ophthalmic Technologies, and the implant has recently completed Phase II/III clinical trials. The tests showed that the IMT doubled the vision of 2/3 of participants’ eyes (3 lines on a visual acuity chart) after one year with the implant. Some patients experienced side effects like intraocular pressure and inflammation, though these may have been related to the surgury. On March 27, an advisory panel for the Food and Drug Administration (FDA) unanimously recommended the prosthetic for approval. Barring any unforeseen events, the IMT will soon gain FDA approval and hit the market soon thereafter.
While the IMT is certainly an amazing breakthrough, it is just one of many technologies we’ve reported on that are overcoming blindness (such as bionic eyes and gene therapy). Besides the direct clinical application of such amazing technology, eye implants beg the question of how far these kinds of advances will go. Who knows? Maybe your grandkids will sport bionic eyes capable of zooming, night vision, and infrared perception. Regardless, anatomical prosthetics like the IMT promise to improve individuals’ lives today, and lay the theoretical foundation for exciting technology to come.
Written on April 10, 2009 – 10:45 am | by Drew Halley |
imt_photoFor the millions of people who suffer from age-related eye degeneration, restoring sight to the blind might sound less like reality and more like a miracle. But thanks to an incredible miniature eye implant that works to restore central vision, the future’s looking bright.
The macula is a part of the retina responsible for highly detailed central vision. It contains a high density of cone cells, which allow us to perceive fine detail and quick movement in our environment - for healthy individuals, that is. Patients suffering from age-related macular degeneration (AMD) partially or totally lose this functionality, resulting in a “blind spot” where their focal point normally rests. This can make it difficult to read, recognize faces, or even watch television… until now.
The Implantable Miniature Telescope, or IMT, is a tiny prosthetic implanted into the patient’s eye. Rather than directing light to the damaged macula, the telescope projects the image onto a broader surface of the retina that surrounds the macula. In this way, visual information is redirected to healthy rods and cones, and can be processed in the brain as central vision.
Both central and peripheral vision are important functions of the visual system. Because of this, the IMT is only implanted into one eye of patients with macular degeneration. One eye continues to process peripheral vision normally (which is better suited for low-light vision, for example), while the implanted eye restores the central vision that was previously impaired. This allows individuals to again experience the full range of visual stimuli so necessary to everyday life. And because the implant is embedded in the iris, it goes unnoticed to others.
A simulation of impaired vision caused by AMD
Macular degeneration primarily effects older adults, and is the leading cause of blindness in the elderly. Nearly 15 million people suffer from AMD in the United States alone. Approximately 10% of adults between the ages of 66 and 74 suffer from AMD, a figure that jumps to 30% between the ages of 75 and 85, according to The Eye Digest.
“In an end-stage AMD population, the indicated improvements in this study are substantial compared to risks of surgery,” said study coauthor R. Doyle Stulting, M.D., Ph.D. “For patients with this level of visual impairment, the ability to be less dependent on others and to reclaim even a few of the activities they once enjoyed could make a real difference in their lives.”
The IMT was developed by VisionCare Ophthalmic Technologies, and the implant has recently completed Phase II/III clinical trials. The tests showed that the IMT doubled the vision of 2/3 of participants’ eyes (3 lines on a visual acuity chart) after one year with the implant. Some patients experienced side effects like intraocular pressure and inflammation, though these may have been related to the surgury. On March 27, an advisory panel for the Food and Drug Administration (FDA) unanimously recommended the prosthetic for approval. Barring any unforeseen events, the IMT will soon gain FDA approval and hit the market soon thereafter.
While the IMT is certainly an amazing breakthrough, it is just one of many technologies we’ve reported on that are overcoming blindness (such as bionic eyes and gene therapy). Besides the direct clinical application of such amazing technology, eye implants beg the question of how far these kinds of advances will go. Who knows? Maybe your grandkids will sport bionic eyes capable of zooming, night vision, and infrared perception. Regardless, anatomical prosthetics like the IMT promise to improve individuals’ lives today, and lay the theoretical foundation for exciting technology to come.
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