Bayer/Regeneron’s Eylea approved in Japan for DME

German pharma major Bayer’s (BAYN: DE) Japanese subsidiary, Bayer Yakuhin, has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for Eylea (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME).

The approval of Eylea for DME in Japan is based on positive data from the VIVID-DME and VISTA-DME studies and one open label single arm safety trial in Japanese patients (VIVID-Japan). In the Phase III VIVID-DME and VISTA-DME trials, aflibercept solution for injection 2mg dosed monthly and aflibercept solution for injection 2mg dosed every two months (after five initial monthly injections), achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. Further, patients treated with aflibercept solution for injection every two months on average gained more than two lines of vision at one year versus laser, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity.

Drug licensed from Regeneron