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Regeneron Announces FDA Acceptance Of EYLEAA® (aflibercept) Injection Supplemental Biologics License Application For Review For Diabetic Macular Edema Indication

TARRYTOWN, N.Y., Dec. 18, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA ® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of August 18, 2014.

"Diabetes is a growing public health concern and DME is a leading cause of vision loss in patients with diabetic retinopathy," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "We hope to be able to offer a new treatment option to patients who suffer from diabetic macular edema."

The EYLEA sBLA submission is based on the positive results from the Phase 3 VIVID and VISTA trials.

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 (EU), 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 following CRVO, as well as in selected countries in Asia and Latin America.  Regulatory submissions have also been made in the EU for EYLEA in DME.

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 Program

The 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 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, 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.

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