Regeneron announced that the FDA has accepted for standard review its supplemental Biologics License Application (sBLA) for Eylea (afilbercept) Injection for the treatment of Diabetic Macular Edema (DME). Eylea is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1.
The submission was based on positive results from the Phase 3 VIVID and VISTA trials. Regeneron’s Phase 3 DME program consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST-DME and one open-label, single arm safety trial in Japanese patients (VIVID-Japan). All three double-masked studies have three treatment arms, where patients are randomized to receive either Eylea 2mg monthly, Eylea 2mg every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation. The primary endpoint of all three studies is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart. The VIVID-DME, VISTA-DME, and VIVID-EAST-DME studies are ongoing.
Eylea is already approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and for macular edema following central retinal vein occlusion (CRVO).
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