On Monday Regeneron reported more positive data for its wet AMD/macular edema drug Eylea (aflibercept). This time, it’s in patients with macular edema following branch retinal vein occlusion (BRVO), a potentially blinding retinal disorder caused by a blockage in the blood vessels branching from the main vein draining the retina.
The biotech, which said it intends to submit a regulatory application for marketing approval for a possible BRVO indication in the US within the next several months, added that the Phase III trial was the eighth positive one for Eylea.
Regeneron was already prepping an NDA submission for diabetic macula edema (DME), while its European marketing partner, Bayer, is on track to do the same abroad. Roche’s wet AMD drug Lucentis already has DME on its label.
As FiercePharma pointed out, Eylea’s two existing indications—wet AMD and for macular edema following central retinal vein occlusion (CRVO)—generated US revenue of $643.7 million in the first half of this year, with some of that going to ex-US marketing partner Bayer.
