The European Commission has approved Eylea for the treatment of visual impairment due to macular edema following retinal vein occlusion, according to a press release from Regeneron.
Eylea (aflibercept) was previously approved for macular edema secondary to central retinal vein occlusion. Macular edema following branch retinal vein occlusion is included in the new indication.
The approval is based on positive data from the phase 2 VIBRANT study, which included patients with visual impairment due to macular edema secondary to BRVO.
Eylea is currently approved in the U.S. for the treatment of wet age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion. Eylea is approved in Europe and other markets for the treatment of wet AMD and DME, the release said.
Regeneron has exclusive rights to Eylea in the U.S., while Bayer Healthcare has exclusive marketing rights outside of the U.S.