Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd. has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for EYLEA® (aflibercept) Injection for myopic choroidal neovascularization (myopic CNV).
EYLEA has already been approved in Japan for the treatment of patients with neovascular age-related macular degeneration (wet AMD), and macular edema secondary to central retinal vein occlusion (CRVO). Marketing authorization applications have been submitted in Japan for the treatment of diabetic macular edema (DME) and macular edema secondary to branch retinal vein occlusion (BRVO).
EYLEA is approved in the United States, European Union (EU) and other countries for the treatment of wet AMD, Macular Edema following CRVO, and DME. Regulatory submissions have been made for EYLEA in the U.S., EU, and Japan for Macular Edema following Branch Retina Vein Occlusion (BRVO).
Regeneron Pharmaceuticals, Inc.