Eylea Gains Expanded Macular Edema Indication
Regeneron announced that the Food and Drug Administration (FDA) has approved Eylea (aflibercept) injection for the treatment of macular edema following retinal vein occlusion (RVO), including macular edema following branch retinal vein occlusion (BRVO) in addition to macular edema following central retinal vein occlusion (CRVO).
The FDA approval of the expanded indication is supported by the previously approved indication for macular edema following CRVO and the positive results from the VIBRANT study, a Phase 3 double-masked, randomized, controlled study. The study (n=181) compared Eylea 2mg once every 4 weeks with macular laser photocoagulation. At Week 24, significantly more patients treated with Eylea gained at least 15 letters in vision from baseline as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart vs. those who received the macular laser photocoagulation (53% vs. 27%, P<0.01).
Eylea is approved for the treatment of wet age-related macular degeneration (AMD), macular edema following RVO, and diabetic macular edema (DME). Eylea is available as a single, 2mg strength intravitreal injection.
For more information call (855) 734-3648 or visit Eylea.com.