Regeneron announced positive top-line results for Eylea (afilbercept) Injection from its Phase 3 VIBRANT study in patients with macular edema following branch retinal vein occlusion (BRVO). Eylea is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1.
The VIBRANT trial was a double-masked, randomized, active-controlled study of 183 patients with macular edema following BRVO. Patients received either intravitreal Eylea 2mg every four weeks or laser treatment, through week 24. The primary objective of the study was to evaluate the efficacy and safety of Eylea in improving best-corrected visual acuity compared to laser treatment at week 24. The study is ongoing through week 52.
In this trial, 53% of patients who received Eylea 2mg 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). VIBRANT is the first Phase 3 trial in this indication in which an anti-VEGF agent was directly compared to an active comparator.
Eylea is already approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and for macular edema following central retinal vein occlusion (CRVO).
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