Regeneron announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea (afilbercept) injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
The approval of Eylea in DME was supported by the Phase 3 VIVID-DME and VISTA-DME trials, which included a pre-specified secondary endpoint evaluating diabetic retinopathy based on established grading scales in patients with DME. In September 2014, the FDA had granted Breakthrough Therapy designation to Eylea Injection for the treatment of diabetic retinopathy in patients with DME.
Eylea is a vascular endothelial growth factor (VEGF) inhibitor, already indicated for the treatment of neovascular wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and DME.
For more information call (855) 734-3648 or visit Regeneron.com.