Trial will evaluate aflibercept to treat DME in Russia, Asia

Tarrytown, NY and Berlin-Regeneron Pharmaceuticals Inc. and Bayer HealthCare have initiated a new phase III trial (named VIVID EAST-DME) to evaluate the efficacy and safety of aflibercept (Eylea) injection in the treatment of diabetic macular edema (DME) in Russia, China, and other Asian countries. The companies are extending their global development program for EYLEA in DME after promising results in the global phase II DME program.

Aflibercept was approved in the United States for the treatment of neovascular (wet) age-related macular degeneration (AMD) in November 2011 and for macular edema following central retinal vein occlusion in September 2012. In Japan aflibercept was approved for use in wet AMD in September 2012. It was also approved in Europe, Australia, and in several other countries for use in wet AMD last year.

“DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes and represents a significant unmet medical need, especially in China, where currently the only therapy for DME is macular laser photocoagulation,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development. “With this new trial, we look forward to bringing [potentially] another treatment option to patients with DME in Asia and Russia.”

Bayer HealthCare and Regeneron are collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to aflibercept in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of aflibercept.

For more articles in this issue of Ophthalmology Times eReport, click here.