Showing posts with label drusen. Show all posts
Showing posts with label drusen. Show all posts

Sunday, January 9, 2011

FDA approves embryonic stem cells to reverse macular degeneration

by:Admin

Sacramento is now the hub of stem-cell research focusing on regenerative medicine. See the article, UC Davis: Stem Cell Research. After receiving $62 million for stem cell research last year, the new UC Davis Institute for Regenerative Cures opened. And the center already is testing dozens of therapies in the laboratory. The center will bring 200 scientists and laboratory personnel together under one roof. Check out the UC Davis Stem Cell Institute. See UC Davis Stem Cell Program. And check out the site, UCDMC Stem Cell Research News.

Now that the FDA has approved embryonic stem cells today, to help reverse certain types of macular degeneration, consumers should know that the stem cell taken from an embryo does not destroy the embryo. Just a single stem cell is taken from the embryo. Then the embryo continues to thrive and is not destroyed.

California sites currently under consideration for the trials include the Jules Stein Eye Institute at UCLA and the Ophthalmology Department at Stanford University. Check out the government site listing clinical trials, Clinical Trials.gov.
Also, in the Sacramento and Davis regional area, did you know that the University of California is recruiting for or has completed at least 193 clinical trials on various types of health studies ranging from the health benefits of ground flax seeds to stem cell research? Also see the January 4, 2011 news article, Read: Vitamin Drug Could Stop Dry Macular Degeneration.

Concerning studies at another university on macular degeneration and stem cell research, if you're interested in stem cell research for macular degeneration, the breaking news is that the FDA has just approved the use of stem cells to treat certain types of macular degeneration. According to a January 4, 2011 news article, "FDA Approves Stem Cell Treatment Trial for AMD-Related Vision Loss," the US Food and Drug Administration (FDA) has approved a clinical trial of human embryonic stem-cell treatments on patients who have suffered vision loss related to dry age-related macular degeneration (AMD).

Advanced Cell Technology of Massachusetts will begin a Phase I/II open-label study on twelve patients at multiple clinical sites to determine the safety and tolerability of the treatment. The dry version of macular degeneration is a leading cause of blindness in older adults. Dry age-related macular degeneration is one of two forms of an eye disease that breaks down retinal pigment epithelial (RPE) cells in the macula of the retina, a layer of light-sensitive tissue at the back of the eye. Progressive loss of RPE cells and the accompanying loss of photoreceptors can cause severe vision loss. There are no current treatments available for AMD.

Dry AMD is the leading cause of blindness in individuals over the age of 55, afflicting approximately 10 million people in the US. And as the population ages, according to the article, "FDA Approves Stem Cell Treatment Trial for AMD-Related Vision Loss."

In the clinical trials and approved experiments, patients will receive 50,000 to 2,000,000 RPE cells derived from human embryonic stem cells to replace those lost due to AMD. While human embryonic stem cell use is controversial, ACT maintains that their cells are derived from a single-cell extraction technology that “does not destroy the embryo.” Also read the article, Read: Smoking Raises Risk of Macular Degeneration.

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.

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.

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.

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  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.”