Bayer submits MAA in Europe for EYLEA to treat macular edema after CRVO

Published on December 6, 2012 at 3:11 AM · No Comments

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for EYLEA (aflibercept) Injection for the treatment of macular edema following Central Retinal Vein Occlusion (CRVO).

"It is our pleasure to announce the filing for EYLEA for the macular edema following CRVO indication with the European Regulatory Authority (EMA) immediately after receiving approval for the treatment of wet age-related macular degeneration.  We hope this will extend the benefits of EYLEA as a new treatment option to European patients with macular edema secondary to central retinal vein occlusion," said Kemal Malik, M.D., Head of Global Development and member of the Bayer HealthCare Executive Committee.  "With 52 weeks results of two Phase 3 trials showing substantial and sustained improvement in vision relative to the sham control group, EYLEA has the potential to provide patients and physicians a new treatment option for central retinal vein occlusion."

The submission of EYLEA for Macular Edema following CRVO is based on data from the Phase 3 COPERNICUS and GALILEO studies.  In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 ETDRS letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline on the ETDRS visual acuity charts.  The EYLEA 2 milligrams (mg) monthly group was significantly superior to the sham control group for the primary endpoint.  The effects were largely maintained until week 52. 

EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA. 

EYLEA was approved in the United States for the treatment of wet AMD in November 2011 and for macular edema following CRVO in September 2012.  EYLEA was also approved in Europe, Japan, Australia, and in several other countries earlier this year for use in wet AMD.

Phase 3 trials are currently under way with EYLEA in the treatment of diabetic macular edema (DME), branch retinal vein occlusion (BRVO), and myopic choroidal neovascularization (mCNV).

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 will share equally the profits from any future sales of EYLEA.

Source:

Regeneron Pharmaceuticals

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