TARRYTOWN, N.Y., Aug. 6, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare 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.
The VIVID-DME and VISTA-DME trials are similarly designed, randomized, double-masked, active control trials to evaluate the safety and efficacy of EYLEA in patients with DME. Patients in both trials were randomized to receive either EYLEA 2 milligrams (mg) monthly, EYLEA 2 mg every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation.
"We are pleased with these positive data in another potentially important indication for EYLEA," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Diabetes is a growing disease worldwide and DME is a major cause of vision loss in people with diabetic retinopathy. We hope to be able to offer a new treatment option for patients suffering from this potentially blinding retinal disease."In the VIVID-DME trial, after one year patients receiving EYLEA 2 mg monthly had a mean change from baseline in BCVA of 10.5 letters (p<0.0001 compared to laser) and patients receiving EYLEA 2 mg every other month (after 5 initial monthly injections) had a mean change from baseline in BCVA of 10.7 letters (p<0.0001 compared to laser), compared to patients receiving laser photocoagulation who had a mean change from baseline in BCVA of 1.2 letters.