Industry News — Clinical Updates
VIBRANT Study Yields Positive Results for Eylea in Treating Macular Edema Following BRVO
October 21, 2013 – Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) announced positive top-line results for Eylea (aflibercept) from the phase 3 VIBRANT trial in treating macular edema following branch retinal vein occlusion (BRVO).
VIBRANT was a double-masked, randomized, active-controlled study of 183 patients with macular edema following BRVO. In the trial, 53% of patients who received aflibercept 2 mg every 4 weeks gained at least 15 letters in vision from baseline at week 24, the primary endpoint of the study. This compares with 27% of patients in the laser group (P < .001) who had the same gain.
In addition, patients who received aflibercept 2 mg every 4 weeks achieved a 17.0-letter mean improvement over baseline in best-corrected visual acuity (BCVA) compared with a 6.9-letter mean improvement in patients who received laser (P < .0001), a key secondary endpoint.
The incidence of serious adverse events (SAE) was 9.9% in the aflibercept group and 9.8% in the laser group. One death and 1 Anti-Platelet Trialists' Collaboration (APTC)-defined event (non-fatal stroke) occurred in the laser group. The most common ocular adverse events in the aflibercept group were conjunctival hemorrhage and eye pain; there were no cases of intraocular inflammation. There was one ocular SAE (traumatic cataract) in the aflibercept group.
VIBRANT is the first phase 3 trial for this indication in which an anti-VEGF agent was directly compared with an active comparator and is the eighth positive trial from the aflibercept phase 3 program.
Regeneron intends to submit a US regulatory application within the next several months to gain marketing approval for aflibercept in the treatment of macular edema following BRVO.
Posted October 21, 2013