FDA approves Eylea for BRVO

Regeneron Pharmaceuticals, Inc., announced that the FDA has approved Eylea (aflibercept) for macular edema following branch retinal vein occlusion (BRVO).

Eylea is already approved for central retinal vein occlusion (CRVO) and for wet AMD and diabetic macular edema.

The expanded indication in the United States is based on the previously-approved indication for macular cdema following CRVO and the positive results from the double-masked, randomized, controlled phase 3 VIBRANT study of 181 patients with macular edema following BRVO.

The 52-week study compared Eylea 2 mg once every four weeks with macular laser photocoagulation. At 24 weeks, significantly more patients treated with Eylea gained at least 15 letters in vision compared with the laser group (53 percent vs. 27 percent; P < 0.01), and the Eylea group achieved a greater improvement in baseline BCVA (17.0 vs. 6.9 letter mean improvement; P < 0.01).

Regulatory approval for Eylea for BRVO is underway in the EU and other countries.