FDA approves Eylea for macular edema following BRVO

The U.S. Food and Drug Administration has approved Eylea for the treatment of macular edema following branch retinal vein occlusion, Regeneron Pharmaceuticals announced in a press release.

Eylea (aflibercept) was previously approved for macular edema following central retinal vein occlusion (CRVO).

“Retinal vein occlusion (RVO) is a significant cause of vision impairment in the U.S., and this expanded indication across all forms of RVO will provide an important new treatment option for retina specialists and their patients,” George D. Yancopoulos MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in the release. “Regeneron remains committed to studying Eylea for the treatment of multiple VEGF driven retinal diseases.”

The FDA’s approval is based on results of the VIBRANT study, a phase 3, randomized, controlled trial that included 181 patients with macular edema following branch retinal vein occlusion (BRVO). The study compared aflibercept 2 mg once every 4 weeks with macular laser photocoagulation.

Results showed that at 24 weeks, significantly more patients treated with aflibercept gained at least 15 letters of vision from baseline compared with patients treated with photocoagulation, at 53% vs. 27%, respectively.

Patients treated with aflibercept gained a mean 17 letters of best corrected visual acuity compared with patients treated with photocoagulation, who gained a mean 6.9 letters.

Non-ocular serious adverse events occurred in 8.8% of patients in the afliberept group and 9.8% of patients in the photocoagulation group, according to the release.