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Mar 8, 2012

Regeneron, Bayer Confirm Australian Approval of Eylea for Wet AMD

  • Regeneron Pharmaceuticals and Bayer HealthCare confirmed Australian regulatory approval for Eylea® (aflibercept) injection, for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). FDA approved the drug for the same indication in November 2011. Austalian clearance of Eylea was based on data from the Phase II View 1 and View 2 trials, which demonstrated that the drug was no less effective than more frequent injections of Lucentis (ranibizumab) in terms of maintaining visual acuity.

    Eylea is currently undergoing Phase III development for wet AMD in China, and regulatory filings have been made in Euope, Japan, and other countries. The drug is in addition being evaluated in Phase III studies as a treatment for diabetic macular edema, myopic choroidal neovascularisation, and branch retinal vein occlusion. An sBLA for the use of Eylea in the treatment of central vein retinal occlusion has been filed in the U.S.

    Eylea (also known as VEGF Trap-Eye) is a recombinant fusion protein comprising parts of the human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1. The drug is formulated for administration as an intravitreal injection. Bayer HealthCare and Regeneron are collaborating on global development, with Regeneron retaining exclusive rights to Eylea in the U.S., and Bayer Healthcare retaining exclusive marketing rights outside the U.S., where the partners will share equally on profits from future sales.

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