Eyetech Pharmaceuticals Inc and Pfizer Inc announced that they have completed the filing of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Macugen (pegaptanib sodium injection) as a treatment for wet age-related macular degeneration.
Macugen received fast track designation from the FDA, which is a process intended for products that address unmet medical needs. The NDA was also entered into the "Pilot 1" programme, which allows the FDA to complete reviews of individual reviewable units within six months of submission and provide early feedback on the pre-submissions. In addition, the FDA recently announced that its Dermatologic and Ophthalmic Drugs Advisory Committee would review Macugen on August 27, 2004.
Macugen is a pegylated anti-VEGF aptamer, which binds to and thus inhibits the activity of vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the primary pathological processes responsible for the vision loss associated with wet AMD.
Wet age-related macular degeneration is the leading cause of severe vision loss in patients older than 50 years of age in the developed world.