Regeneron Pharmaceuticals and Bayer HealthCare announced results from the Phase 3 VISTA-DME trial of Eylea (aflibercept) Injection for the treatment of diabetic macular edema (DME). Eylea is a recombinant fusion protein consisting of a human VEGF inhibitor and human IgG1.
The global 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 dosed monthly (2Q4), Eylea 2mg dosed every two months (after 5 initial monthly injections; 2Q8), 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 studies are still ongoing.
Eylea 2mg 2Q4 and Eylea 2mg 2Q8 months showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared to laser photocoagulation. After two years, patients receiving Eylea 2mg 2Q4 had a mean change from baseline in BCVA of 11.5 letters (12.5 letters at 52 weeks). Patients receiving Eylea 2mg 2Q8 had a mean change from baseline in BCVA of 11.1 letters (10.7 letters at 52 weeks). Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.9 letters (0.2 letters at 52 weeks).
Eylea is already approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (CRVO).
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