Industry News — Clinical Updates

Eylea Gains Approval in Japan for Treating Myopic CNV

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Eylea (aflibercept, Regeneron Pharmaceuticals, Inc., Tarrytown, NY) for treating myopic choroidal neovascularization (CNV). MHLW has already approved Eylea in Japan for neovascular AMD and macular edema secondary to central retinal vein occlusion (CRVO).

Bayer Yakuhin, Ltd., the Japanese subsidiary of Bayer HealthCare, has also submitted marketing authorization applications in Japan for Eylea for diabetic macular edema (DME) and macular edema secondary to branch retinal vein occlusion (BRVO).

Eylea is approved in the US, European Union (EU), and other countries for the treatment of wet AMD, CRVO, and DME. Regulatory submissions have been made in the US and EU for Eylea for macular edema following BRVO.

Bayer HealthCare and Regeneron collaborate on the global development of Eylea. Regeneron maintains exclusive rights in the US, and Bayer HealthCare has exclusive marketing rights outside the US.

Updated September 22, 2014