Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA® (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO).
"We are pleased with the approval of EYLEA in the E.U. in a second indication," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Our Phase 3 studies showed that EYLEA improved visual outcomes significantly in Macular Edema following CRVO. This additional approval of EYLEA is great news for patients in Europe suffering from Macular Edema following CRVO, a debilitating disease affecting central vision."
EYLEA 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 CRVO in September 2012. EYLEA has also been approved in Europe, Japan, Australia, and in several other countries for use in wet AMD and in selected countries in South America for Macular Edema following CRVO.
Bayer HealthCare and Regeneron are collaborating on the global 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 share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.