Companies seek EU approval for Eylea to treat ME after CRVO

Tarrytown, NY, and Berlin, Germany--Regeneron Pharmaceuticals Inc. and Bayer HealthCare reported that Bayer HealthCare has submitted an application for marketing authorization in Europe for Eylea (aflibercept) injection for the treatment of macular edema (ME) following central retinal vein occlusion (CRVO).

"It is our pleasure to announce the filing for Eylea . . . with the European Regulatory Authority immediately after receiving approval for the treatment of wet age-related macular degeneration (AMD),” said Kemal Malik, MD, head of global development and member of the Bayer HealthCare Executive Committee. “We hope this will extend the benefits of Eylea as a new treatment option to European patients with ME secondary to CRVO."

The submission of Eylea for ME following CRVO is based on data from the phase III Copernicus and Galileo studies, the companies reported. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 ETDRS letters of best-corrected visual acuity at 24 weeks compared to baseline on the ETDRS visual acuity charts. The Eylea 2-mg monthly group was significantly superior to the sham control group for the primary endpoint. The effects were largely maintained until week 52.

Eylea was approved in the United States in November 2011 for the treatment of wet AMD and later approved in September 2012 for ME following CRVO. The drug is also approved in Europe, Japan, Australia, and several other countries to treat wet AMD.

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