TARRYTOWN, N.Y., Nov. 7, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that Bayer HealthCare has submitted an application for marketing authorization in the European Union (EU) for EYLEA ® (aflibercept) Injection for the treatment of patients with Diabetic Macular Edema (DME). Regeneron has submitted a supplemental BLA for EYLEA in this indication to the U.S. Food and Drug Administration (FDA).
"Diabetes is a growing, worldwide health concern and DME is a major cause of vision loss in those with diabetic retinopathy," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "We are pleased with this regulatory submission in a third indication for EYLEA in Europe and, if approved, hope to be able to offer physicians and patients a new treatment option."
The submission of EYLEA for DME is based on data from the positive Phase 3 VISTA-DME and VIVID-DME studies. One-year data from both trials have been presented at medical conferences. The VISTA-DME and VIVID-DME trials are planned to continue up to 148 weeks.
EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has also been approved in the European Union, Japan, Australia, and in several other countries for use in wet AMD. EYLEA has also been approved by the European Commission for the treatment of visual impairment due to macular edema secondary to CRVO, as well as in selected countries in Asia and Latin America.Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales. About the EYLEA ® (aflibercept) Injection Phase 3 DME ProgramThe Phase 3 DME program consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST-DME (in Russia, China and other Asian countries), 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 2 milligrams (mg) monthly, EYLEA 2 mg every two months (after 5 initial monthly injections), 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, a standard chart used in research to measure visual acuity. The VIVID-DME, VISTA-DME, and VIVID-EAST-DME studies are ongoing. About Diabetic Macular Edema (DME)DME is a common complication of Diabetic Retinopathy (DR), a disease affecting the blood vessels of the retina. Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness. DME is the most frequent cause of blindness in young and mid-aged adults. According to the American Diabetes Association, over 18 million Americans currently suffer from diabetes, and many more are at risk for developing diabetes. The incidence of diabetes is steadily climbing and it is projected that up to seven percent of all patients with diabetes will develop DME during their lifetime.