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news.Bayer Yakuhin has filed a marketing authorization application (MAA) with the Japanese Ministry of Health, Labor and Welfare (MHLW) for EYLEA (aflibercept injection) as a treatment of neovascular form of age-related macular degeneration (wet AMD).
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The filing of the application is supported by the results of two Phase 3 trials, VIEW 1 and VIEW 2, conducted in Europe, Japan and other countries.
The studies met the primary endpoint of statistical non-inferiority compared to ranibizumab 0.5mg, a current standard of care dosed every month, in the proportion of patients who maintained (or improved) vision over 52 weeks.
Regeneron and Bayer HealthCare are set to sign a pact for the global development of EYLEA as a treatment for central retinal vein occlusion (CRVO), myopic choroidal neovascularization (mCNV), wet AMD and diabetic macular edema (DME).
EYLEA will be marketed by Bayer HealthCare outside the US and the profits will equally shared by both the companies from future sales of EYLEA.