Phase III success for Eylea (Regeneron/Bayer) for BRVO

Regeneron Pharmaceuticals/Bayer HealthCare, Inc. announced positive topline results for Eylea (aflibercept) Injection from the Phase III VIBRANT study in patients with Macular Edema following Branch Retinal Vein Occlusion (BRVO). In this trial, 53% of patients who received Eylea 2 milligram (mg) every four weeks gained at least 15 letters in vision from baseline at week 24, the primary endpoint of the study, compared to 27% of patients who received laser, a standard-of-care treatment (p < 0.001). Patients who received Eylea 2 mg every four weeks 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 laser (p < 0.0001), a key secondary endpoint.

VIBRANT is the first Phase III trial in this indication in which an anti-VEGF agent was directly compared to an active comparator. The incidence of serious adverse events (SAE) was 9.9% in the Eylea group and 9.8% in the laser group. One death and one Anti-Platelet Trialists' Collaboration (APTC) defined event (non-fatal stroke) occurred during the trial, both in patients in the laser group. The most common ocular adverse events in the Eylea treated patients were conjunctival haemorrhage and eye pain. There were no cases of intraocular inflammation. There was one ocular SAE in a patient in the Eylea group, which was a traumatic cataract.Detailed results from this study will be presented at an upcoming medical conference.

Regeneron/Bayer intends to submit a regulatory application for marketing approval for macular edema following BRVO in the U.S. within the next several months.