FDA extends indication for Eylea to BRVO-Regeneron Pharma

The FDA has approved Eylea (aflibercept) Injection, from Regeneron Pharmaceuticals, for the treatment of Macular Edema following Retinal Vein Occlusion (RVO), which includes Macular Edema following Branch Retinal Vein Occlusion (BRVO) in addition to the previously-approved indication of Macular Edema following Central Retinal Vein Occlusion (CRVO). The recommended dosage of EYLEA in patients with Macular Edema following RVO is 2 milligrams (mg) every month (4 weeks).

The expanded indication is based on the previously-approved indication for Macular Edema following CRVO and the positive results from the double-masked, randomized, controlled Phase III VIBRANT study of 181 patients with Macular Edema following BRVO. The VIBRANT study compared EYLEA 2 mg once every 4 weeks with macular laser photocoagulation (control). At 24 weeks, significantly more patients treated with EYLEA gained at least 15 letters in vision (three lines on an eye chart) from baseline as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, the primary endpoint of the study, compared with patients who received control (53 percent vs. 27 percent). Patients treated with EYLEA achieved a 17.0 letter mean improvement over baseline in best-corrected visual acuity (BCVA) compared to a 6.9 letter mean improvement in patients who received control, a key secondary endpoint. The incidence of non-ocular serious adverse events (SAE) was 8.8 percent in the EYLEA group and 9.8 percent in the control group.