EYLEA Injection Recommended For Approval Regarding Treatment Of Visual Impairment Due To Diabetic Macular Edema In The European Union

Regeneron Pharmaceuticals, Inc.

today announced that EYLEA® (aflibercept) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular edema (DME). The decision of the European Commission is expected in the second half of 2014. "Diabetes is a growing health concern worldwide and this milestone brings us one step closer to being able to offer patients and physicians in the European Union a new therapeutic option for the treatment of diabetic macular edema," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. The European Union (EU) submission is based on positive data from the Phase 3 VIVID-DME and VISTA-DME studies. In the Phase 3 VIVID-DME and VISTA-DME trials, EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg dosed every two months (after 5 initial monthly injections) both achieved the primary endpoint of significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. In these trials, EYLEA was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the treatment groups and the laser control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across the treatment groups and the laser control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME trials included conjunctival hemorrhage, eye pain, and vitreous floaters. The most frequent non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the laser control group. One-year data from the VIVID-DME and VISTA-DME trials and two-year data from the VISTA-DME trial have been presented at medical congresses. Two-year data from the similarly designed VIVID-DME trial are expected later in 2014. Each of the VISTA-DME and the VIVID-DME trials is expected to continue as planned 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 EU and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have been made in Japan, Asia Pacific, Latin America and the U.S., for the treatment of Diabetic Macular Edema. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Regulatory submissions have been made in the U.S. and the EU for EYLEA for the treatment of DME. A regulatory submission has been made in the U.S. for EYLEA for the treatment of macular edema following Branch Retinal Vein Occlusion (BRVO). 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 percentage of net sales. About the EYLEA® (aflibercept) Injection Phase 3 DME Program The Phase 3 DME program consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST-DME, 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 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. The treatable population for DME globally is estimated at about 6.2 million people. 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.