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.

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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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