Regeneron announces regulatory submission in Japan

|By:, SA News Editor

Bayer (BAYRY) has filed for Japanese approval of Regeneron's (REGN) Eylea therapy for treating patients with diabetic macular edema, the companies have said. Bayer has the rights to sell Eyelea outside the U.S.

The submission is based on Phase 3 clinical trials that proved a statistically significant improvement in best-corrected visual acuity from baseline at 52 weeks compared with laser photcoagulation.

The companies didn't provide a timetable for marketing approval, although the process is usually slower than with the FDA in the U.S. (PR)