FDA to Review Eylea for Diabetic Macular Edema

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.

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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). 

For more information call (855) 734-3648 or visit EYLEA.com.