Zoom imagePhysician Elvira Allakhiarova (right) with patient Rosemarie Pingen in Cologne University Hospital.
Bayer HealthCare has submitted applications for marketing authorization to both the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labor and Welfare (MHLW) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Bayer HealthCare is collaborating with Regeneron Pharmaceuticals, Inc. on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV).
“Our large Phase III program demonstrated that patients treated with 2 mg VEGF Trap-Eye every two months, following three loading doses, showed comparable efficacy compared to the current standard of care of monthly injections,” said Dr. Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee. Regeneron submitted a Biologics License Application (BLA) for marketing approval in wet AMD to the U.S. Food and Drug Administration (FDA) in February 2011 and received a Priority Review designation. Bayer will market VEGF Trap-Eye outside the United States, where the companies will share equally the profits from any future sales of the product. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.