FDA approves Eylea for diabetic retinopathy

FDA approved Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat diabetic retinopathy in patients with diabetic macular edema (DME). The human fusion protein that binds all forms of VEGF-A and placental growth factor ( PGF; PlGF) has breakthrough therapy designation in the indication and was under Priority Review.

Eylea already is approved in the U.S. for wet age-related macular degeneration (AMD), macular edema following branch or central retinal vein occlusion (RVO) and DME. FDA based its approval for the new indication on data from the Phase III VISTA-DME and VIVID-DME trials, in which Eylea led to significant improvements in diabetic retinopathy severity scale (DRSS) scores compared to macular laser photocoagulation. ...