Updated on 10 January 2013
Will Bayer Yakuhin's VEGF Trap-Eye get marketing authorization in Japan?
Singapore: Bayer HealthCare announced that Bayer Yakuhin, Osaka, Japan, has submitted an application for marketing authorization for VEGF Trap-Eye (aflibercept solution for injection) for the treatment of macular oedema following Central Retinal Vein Occlusion (CRVO) to the Ministry of Health, Labour and Welfare (MHLW) in Japan.
The submission of VEGF Trap-Eye for macular edema following CRVO is based on data from the phase III Copernicus and Galileo studies. In both studies, the primary efficacy endpoint was the proportion of patients, who gained at least 15 letters 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.
VEGF Trap-Eye was approved under the brand name Eylea in the US for the treatment of wet AMD in November 2011 and for macular oedema following CRVO in September 2012. In Japan Eylea was approved for use in wet AMD in September 2012. EYLEA has also been approved in Europe, Australia, and in several other countries for use in wet AMD last year.
Phase III trials are currently under way with VEGF Trap-Eye in the treatment of diabetic macular edema (DME) and myopic choroidal neo-vascularization (mCNV). Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the US. Bayer HealthCare licensed the exclusive marketing rights outside the US, where the companies will share the profits from any future sales of VEGF Trap-Eye equally, except for Japan where Regeneron will receive a royalty on net sales.