Industry News — Clinical Updates

Regeneron and Bayer Seek Eylea Marketing Authorization for DME Treatment in Japan

Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) and Bayer HealthCare (Leverkusen, Germany) announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd. (Osaka, Japan), has submitted an application to the Japan Ministry of Health, Labour and Welfare for marketing authorization for Eylea (aflibercept) for treating diabetic macular edema (DME).

The submission is based on data from the VISTA-DME, VIVID-DME, and VIVID-Japan studies.

Regeneron reports that in the phase 3 VIVID-DME and VISTA-DME trials, aflibercept 2 mg monthly and aflibercept 2 mg every 2 months (after 5 initial monthly injections) achieved the primary endpoint of significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks.

In the trials, aflibercept was generally well tolerated, with a similar overall incidence of adverse reactions across the treatment groups and the laser control group. The most common ocular adverse reactions in VIVID-DME and VISTA-DME included conjunctival hemorrhage, eye pain, and vitreous floaters. The most common non-ocular adverse events included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the laser control group.

Bayer HealthCare and Regeneron are collaborating on the global development of Eylea, and Regeneron maintains exclusive rights in the United States.

Updated: March 4, 2014