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GEN News Highlights : Jun 6, 2013

Promising Phase III Results for Regeneron, Bayer mCNV Candidate

Regeneron Pharmaceuticals and Bayer HealthCare today report positive top-line Phase III results for their EYLEA® (aflibercept) injection for the treatment of myopic choroidal neovascularization (mCNV).

The companies said that participants in the MYRROR study receiving EYLEA at an initial dose of 2 mg followed by treatment on an as-needed basis showed a mean improvement in best-corrected visual acuity from baseline at week 24 of 12.1 letters, compared to a loss of 2.0 letters in patients receiving placebo.

"Effective treatment options are urgently needed for patients with myopic choroidal neovascularization," Bayer HealthCare’s Kemal Malik, M.D., head of global development, said. "We are pleased that the results of this study demonstrate that EYLEA may provide a treatment option for these patients."

Bayer HealthCare and Regeneron are collaborating on the global development of this mCNV drug. Bayer said it expects to submit the first application for regulatory approval for this indication in Asia during the second half of this year.