Horizon scanning: FDA Advisory Committee recommends approval of aflibercept ophthalmic solution (Eylea®) for wet AMD

Source: PharmaLive
Area: News
According to PharmaLive, the Dermatologic and Ophthalmic Drugs Advisory Committee of the US FDA has voted unanimously to recommend the approval of aflibercept ophthalmic solution (Eylea®; also known as VEGF Trap-Eye) for the treatment of the neovascular form of age-related macular degeneration (wet AMD).  An application for marketing authorisation in Europe for this indication was submitted by Bayer in June 2011.   The regulatory submissions are based on the results from two Phase III trials (VIEW 1 and VIEW 2).  In these, all of the evaluated (Read more...)

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