Aflibercept wins European approval for retinal vein occlusion

Regeneron announced that the European Commission has agreed to expand the indication for aflibercept (Eylea) to include macular edema secondary to retinal vein occlusion.

The new indication 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.

The Commission based its approval on results from the Phase 3 VIBRANT study in patients with visual impairment due to macular edema secondary to BRVO.

The recommended treatment approach in the European Union is to initiate therapy with one injection per month, continuing monthly treatment until maximum visual acuity is achieved and/or there are no signs of disease activity. Treatment may then be continued with a treat-and-extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes.