Regeneron Pharmaceuticals has received the US Food and Drug Administration's (FDA) acceptance for reviewing its biologics license application (BLA) for VEGF Trap-Eye to treat neovascular form of age-related macular degeneration (wet AMD).
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The FDA has also granted the its request for priority review of its BLA.
Under priority review, the target date for an FDA decision on the VEGF Trap-Eye BLA is 20 August 2011.
Regeneron and Bayer HealthCare are collaborating on the development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion, diabetic macular edema, myopic choroidal neovascularisation, and other eye diseases and disorders.
Regeneron president and CEO Leonard Schleifer said they look forward to working closely with the FDA to achieve their goal of bringing a new treatment option that offers a major advance to patients with age-related macular degeneration.
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