Regeneron Pharmaceuticals, Inc. (REGN) announced that due to ongoing labeling discussions the U.S. FDA has issued a complete response letter regarding the supplemental Biologics License Application for EYLEA (aflibercept) Injection in patients with wet age-related macular degeneration. Regeneron expects to complete these discussions and receive a final FDA action within approximately two months.
EYLEA (aflibercept) Injection is a vascular endothelial growth factor inhibitor formulated as an injection for the eye. EYLEA is currently approved in wet age-related macular degeneration for every four- or eight-week dosing intervals after three initial monthly doses. Regeneron and Bayer AG collaborate on the global development and commercialization of EYLEA.