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The Food and Drug Administration (FDA) today announced the approval of pegaptanib sodium injection (Macugen), a new therapy to slow vision loss in people with the eye disease neovascular (wet) age-related macular degeneration (AMD). Pegaptanib is a selective vascular endothelial growth factor (VEGF) antagonist.
"Macugen is among the first treatments to target the underlying biology of wet age-related macular degeneration," said Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration. "Macugen provides a needed addition to the treatment of patients with this disease."
AMD, a retinal disease causing severe and irreversible vision loss, is a major cause of blindness in individuals older than 55 years. Untreated, the majority of eyes affected with wet AMD may become functionally blind. Wet AMD, which makes up approximately 10 percent of AMD, is caused by the growth of abnormal leaky blood vessels that eventually damage the area of the eye responsible for central vision, which is essential for most fine detail visual activities, including reading, driving, and recognizing faces. The safety and efficacy of Macugen was studied in two trials in patients with wet AMD for two years. Patients treated with Macugen exhibited a significant decrease in vision loss in both trials. Serious adverse events related to the injection procedure included infections, retinal detachment, and traumatic cataract. Other frequently reported adverse events in patients treated with Macugen were eye irritation, eye pain, hemorrhage under the outer membrane of the eye (conjunctiva), and blurred vision.
The NDA for Macugen was received and approved in 6 months.
Macugen therapy is being co-developed by Eyetech Pharmaceuticals, Inc. and Pfizer Inc. Eyetech and Pfizer will co-market the product in the United States.
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