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EYLEA® (aflibercept) Injection Recommended For Approval For The Treatment Of Visual Impairment Due To Diabetic Macular Edema In The European Union

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.

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