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Regeneron Pharmaceuticals Inc And Bayer AG's Bayer HealthCare Reports Positive Phase 3 Results For EYLEA (aflibercept) Injection In Myopic Choroidal Neovascularization (mCNV)


Thursday, 6 Jun 2013 02:30am EDT 

Regeneron Pharmaceuticals Inc and Bayer HealthCare announced positive top-line results for EYLEA (aflibercept) Injection from the Phase 3 MYRROR study in myopic choroidal neovascularization (mCNV). In this trial, patients receiving EYLEA at an initial dose of 2 milligrams (mg), followed by treatment on an as-needed (PRN) basis, had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, compared to a loss of 2.0 letters in patients receiving sham injections (p <0.0001). The common adverse events observed in the MYRROR trial that occurred with a frequency of 2% or more were conjunctival hemorrhage, dry eye, eye pain, headache and nasopharyngitis. 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, except for Japan where Regeneron will receive a royalty on net sales. 

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