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Regeneron and Bayer announce 12-month results from Phase III studies of aflibercept injection for the treatment of DME

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare have announced one-year results from two Phase 3 studies (VIVID-DME and VISTA-DME) evaluating “Eylea” (aflibercept) for the treatment of diabetic macular edema (DME). In the studies, 2mg Eylea dosed monthly and dosed every two months (after 5 initial monthly injections) achieved the primary endpoint of a significantly greater improvement in best-corrected visual acuity (BCVA) from baseline when compared to laser photocoagulation at 52 weeks. In a press release the company stated that they now expect to submit an application for U.S. marketing approval approximately one year ahead of the previously announced timeline.