LEVERKUSEN (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) and Bayer HealthCare announced positive top-line results for Eylea or aflibercept Injection from the Phase 3 Myrror study in myopic choroidal neovascularization or mCNV.
In this trial, patients receiving Eylea at an initial dose of 2 milligrams (mg), followed by treatment on an as-needed or 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 company said that the most 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 expects to submit the first application for regulatory approval for this indication in Asia in the second half of 2013.
Eylea was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration or AMD in November 2011 and for Macular Edema following Central Retinal Vein Occlusion or CRVO in September 2012. Outside of the U.S., EYLEA has been approved for use in wet AMD in Japan, Australia, Europe, and several other countries.
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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