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$REGN: Regeneron Pharms and Bayer HealthCare (BAYRY) announce regulatory submission of EYLEA injection for the treatment of diabetic macular edema in Japan (332.50)
Regeneron Pharmaceuticals announces that Bayer (BAYRY) HealthCare's Japanese subsidiary, Bayer Yakuhin, has submitted an application for marketing authorization for EYLEA Injection for the treatment of patients with diabetic macular edema to the Japanese Ministry of Health, Labour and Welfare.
The submission of EYLEA for DME in Japan is based on data from the VISTA-DME, VIVID-DME and VIVID-Japan studies. In the Phase 3 VIVID-DME and VISTA-DME trials, EYLEA 2 milligrams dosed monthly and EYLEA 2 mg dosed every two months achieved the primary endpoint of significantly greater improvement in best-corrected visual acuity from baseline compared to laser photocoagulation at 52 weeks.
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