Bayer files for Japanese approval of Eylea for macular edema following CRVO

German drug major Bayer(BAYN: DE) says its subsidiary Bayer Yakuhin has applied to the Japanese Ministry of Health, Labor and Welfare (MHLW) for marketing authorization of VEGF Trap-Eye (aflibercept) injection (trade name Eylea) for the treatment of macular edema following central retinal vein occlusion (CRVO).

Bayer has previously forecast that Eylea will generate sales of over 1 billion euros ($1.3 billion). In Japan, it will be co-marketed by Bayer Yakuhin and Japanese drugmaker Santen Pharmaceutical (TYO: 4536) under an agreement signed last spring (The Pharma Letter May 9, 2012).

The submission is based on data from the Phase III COPERNICUS and GALILEO studies. In both trials, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters – measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart – of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline on the ETDRS visual acuity charts. The VEGF Trap-Eye 2 milligrams monthly group was significantly superior to the sham control group for the primary endpoint. The effects were largely maintained in the follow-up phase until week 52. The 52-week results of the GALILEO and COPERNICUS studies demonstrated a favorable safety profile for VEGF Trap-Eye.