CHMP recommends Eylea (aflibercept) for Macular Edema Secondary to Retinal Vein Occlusion (RVO) including BRVO- Bayer HealthCare + Regeneron

Bayer HealthCare has announced that aflibercept solution for injection into the eye has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with visual impairment due to Macular Edema Secondary to Retinal Vein Occlusion (RVO), which includes Macular Edema following Branch Retinal Vein Occlusion (BRVO) in addition to the previously-approved indication of Macular Edema secondary to Central Retinal Vein Occlusion (CRVO). The positive CHMP recommendation is based on positive results from the double-masked, randomized, active-controlled Phase III VIBRANT study in patients impacted by BRVO. The primary endpoint was the proportion of subjects who gained at least 15 letters in Best Corrected Visual Acuity (BCVA) from baseline at week 24, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity. More than half of the patients who were treated with aflibercept solution for injection gained at least three lines of vision.The previously approved indication of Macular Edema secondary to CRVO was based on data from the Phase III COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 ETDRS letters of BCVA at 24 weeks compared to baseline on the ETDRS visual acuity charts.