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