Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that they have initiated a new Phase III trial (named VIVID EAST-DME) to evaluate the efficacy and safety of EYLEA® (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries. The companies are extending their global development program for EYLEA in DME after promising results in the global Phase II DME program.
The VIVID EAST-DME study (VEGF Trap-Eye In Vision Impairment Due to DME) has three treatment arms. In the first arm, patients will be treated every month with 2 milligrams (mg) of EYLEA. In the second arm, patients will be treated with 2mg of EYLEA every two months after an initial phase of five 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 to week 52 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 a maximum of one year.
The first Phase III trial of EYLEA in DME, named VIVID-DME, is being conducted in Europe and Japan by Bayer HealthCare and is fully enrolled. A second study led by Regeneron, named VISTA-DME, is being conducted in the United States and is fully enrolled as well.
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 7% of all patients with diabetes will develop DME during their lifetime.
âDME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes and represents a significant unmet medical need, especially in China, where currently the only therapy for DME is macular laser photocoagulation,â said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee and Head of Global Development. âWith this new trial, we look forward to potentially bringing another treatment option to patients with DME in Asia and Russia.â
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. In Japan EYLEA was approved for use in wet AMD in September 2012. EYLEA was also approved in Europe, Australia, and in several other countries for use in wet AMD last year.
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 will share equally the profits from any future sales of EYLEA, except for Japan where Regeneron will receive a royalty on net sales.
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