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Regeneron and Bayer Announce Start of Phase 3 Clinical Program in Diabetic Macular Edema
Date:4/8/2011

t Due to DME) has three study arms.  In the first arm, patients will be treated every month with 2 milligrams (mg) of VEGF Trap-Eye.  In the second arm, patients will be treated with 2mg of VEGF Trap-Eye every two months after a loading phase of monthly injections.  In the third arm, the comparator arm, patients will be treated with macular laser photocoagulation.  The primary endpoint is mean change in visual acuity from baseline as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard chart used in research to measure visual acuity.  All patients will be followed for three years.  The VISTA-DME study (VEGF Trap-Eye: Investigation of Safety, Treatment effect, and Anatomic outcomes in DME) is expected to begin later in 2011.

About Diabetic Macular Edema (DME)

DME is the most prevalent cause of moderate vision loss in patients with diabetes.  DME is a common complication of Diabetic Retinopathy (DR), a disease affecting the blood vessels of the retina.  Clinically significant DME is a leading cause of blindness in younger adults (under 50).  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.

According to figures from the World Health Organization, DME is the second leading cause of blindness in Western industrialized countries.  In Europe, about 8% of the population is affected by DME.  Approximately 370,000 Americans currently suffer from clinically significant DME, with 95,000 new cases arising each year.  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
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SOURCE Regeneron Pharmaceuticals, Inc.
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