Positive Ph III results for Regeneron/Bayer's Eylea in mCNV

US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) and partner Germany’s Bayer (BAYN: DE) have reported positive top-line results for Eylea (aflibercept) Injection from the Phase III MYRROR study in myopic choroidal neovascularization (mCNV).

In this trial, patients receiving Eylea at an initial dose of 2mg, 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 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.

Eylea was approved in the USA for the treatment of neovascular (wet) Age-related macular degeneration (AMD) in November 2011 and for macular edema following central retinal vein occlusion (CRVO) in September 2012. Regeneron’s sales of the drug in the USA, where it has retained exclusive rights, reached $838 million in 2012, with $276 million in the last quarter of the year. Outside of the US, Bayer Healthcare territory, Eylea has been approved for use in wet AMD in Japan, Australia, Europe, and several other countries. Bayer has not yet broken out sales figures for the drug.