Regeneron, Bayer Report Positive Results from Phase 3 Trials of EYLEA Injection for Treatment of Diabetic Macular Edema

Regeneron Pharmaceuticals, Inc. REGN and Bayer HealthCare BAYRY today announced that in the Phase 3 VIVID-DME and VISTA-DME trials of EYLEA (aflibercept) Injection for the treatment of diabetic macular edema (DME), EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg 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 compared to laser photocoagulation at 52 weeks.  Both EYLEA treatment arms demonstrated similar improvements in BCVA. Based on discussions with the U.S. Food and Drug Administration (FDA), Regeneron now expects to submit an application for U.S. marketing approval for the treatment of DME in 2013, approximately one year ahead of the previously announced timeline.  Bayer Healthcare plans to submit an application for marketing approval for the treatment of DME in Europe in 2013.  See full press release