Regeneron: FDA approves application for EYLEA Injection for wet AMD

Regeneron Pharmaceuticals announced that the U.S. FDA has approved a supplemental Biologics License Application for EYLEA Injection in patients with wet age-related macular degeneration. The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule. These data are now included in the updated EYLEA label. EYLEA is also approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.

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