EC approves Eylea for DME

The European Commission approved Eylea aflibercept from Bayer AG (Xetra:BAYN) for treating visual impairment due to diabetic macular edema (DME). Bayer has ex-U.S. rights to the drug from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and plans to market the drug this quarter starting in Germany.

An injectable VEGF inhibitor that blocks blood vessel leakage and angiogenesis, Eylea is already approved in the U.S., Japan and the EU for wet age-related macular degeneration (AMD). FDA approved the drug for DME in the U.S. earlier this summer. An sBLA for Eylea to treat macular edema following branch retinal vein occlusion (BRVO) is currently under FDA review. ...