Regeneron announces EU approval of EYLEA (aflibercept) Injection for retinal vascular disease treatment

Feb 26 2015

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 Retinal Vein Occlusion (RVO). The new indication includes Macular Edema following Branch Retinal Vein Occlusion (BRVO) in addition to the previously approved indication of Macular Edema secondary to Central Retinal Vein Occlusion (CRVO). The recommended treatment approach in the European Union (EU) is to initiate the therapy with one injection per month, continuing monthly treatment until maximum visual acuity is achieved and/or there are no signs of disease activity. Treatment may then be continued with a treat and extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes.

EU approval is based on positive data from the Phase 3 VIBRANT study in patients with visual impairment due to macular edema secondary to BRVO.

EYLEA is approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), which includes both CRVO and BRVO, and Diabetic Macular Edema (DME). EYLEA is also approved in the EU and other markets for use in wet AMD and DME.

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 of the United States, where the companies share equally the profits from sales of EYLEA, with the exception of Japan where Regeneron receives a percentage of net sales.

SOURCE Regeneron Pharmaceuticals, Inc.