Friday, November 21, 2008

Angiogenesis Inhibitors

Lucentis® (Generic name: ranibizumab injection)

Year Approved by the FDA: 2006

Effective for: Wet macular degeneration

How it works: Lucentis®is an antibody fragment that binds to and inhibits the biologic activity of human Vascular Endothelial Growth Factor A (VEGF-A), a protein that is believed to play a critical role in the formation of the new abnormal and leaky blood vessels, characteristic of wet macular degeneration. The drug is injected into the vitreous portion of the eye (the clear jelly-like substance that fills the eye from the lens back to the retina). Due to the fact that the production of VEGF-A is ongoing, routine administration of this drug is required.

According to data collected during clinical trials, nearly 95 percent of the participants who received a monthly injection maintained their vision at 12 months following the beginning of treatment compared to approximately 60 percent of patients who received the control treatment. Approximately one-third of patients in these trials had improved vision at 12 months.

Most common side effects: The most commonly reported adverse events included hemorrhage of the conjunctiva (the membrane that covers the white part of the eye), floaters, eye pain, increased eye pressure, and inflammation of the eye. Serious adverse events such as endophthalmitis (severe inflammation of the interior of the eye), retinal detachment, retinal tear, increased eye pressure and traumatic cataract were rare and often related to the injection procedure. There is also a small increase in the risk of stroke. Clinical trial data indicated that approximately .3 percent of patients suffered a stroke when given a .3 milligram dose of Lucentis®compared to 1.2 percent of patients who received a .5 milligram dose. In addition, patients who have previously suffered a stroke may be at greater risk of having another stroke.

No comments: