TARRYTOWN, N.Y. and BERLIN, Nov. 28, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that they have initiated a Phase 3 clinical trial evaluating the efficacy and safety of EYLEA™ (aflibercept) Injection in the neovascular form of age-related macular degeneration (wet AMD) in China.
The new trial, named SIGHT, will include approximately 300 patients and will be the largest retinal trial conducted in China. SIGHT is being led by Bayer.
"Currently, only photodynamic therapy with verteporfin is approved as a treatment for wet AMD in China, and it is only approved for the subpopulation of patients with predominantly classic wet AMD," said Kemal Malik, M.D., Head of Global Development and member of the Bayer HealthCare Executive Committee. "After reporting positive data from our large VIEW program in wet AMD, we look forward to potentially bringing this new treatment to patients with wet AMD in China."
About the SIGHT ProgramThe SIGHT (VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese patients with wet AMD) program consists of a randomized, double-masked, Phase 3 clinical trial evaluating EYLEA (known in the scientific literature as VEGF Trap-Eye) in the treatment of the neovascular form of age-related macular degeneration (wet AMD). EYLEA will be evaluated for its effect on improving and maintaining vision when dosed as an intravitreal injection on a schedule of 2 milligrams (mg) every two months (following three initial monthly doses), as compared with Photodynamic Therapy (PDT) with verteporfin. After assessment of the primary endpoint at week 28, all patients, including those on PDT, will receive EYLEA treatment until the end of the study at week 52. The SIGHT study plans to randomize 300 patients.