Regeneron and Bayer Healthcare announced positive top-line results for Eylea (aflibercept) Injection from a Phase 3 study, MYRROR in myopic choroidal neovascularization (mCNV). Eylea is a recombinant fusion protein, consisting of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1.
MYRROR was a double-masked, sham-controlled trial that randomized 122 patients to receive either Eylea 2mg or sham. Patients in the active treatment arm received one initial 2mg dose of Eylea. Patients were evaluated every 4 weeks and were eligible to receive additional Eylea 2mg intravitreal injections on an as-needed basis through 20 weeks. Patients in the sham arm received monthly sham injections through week 20. Starting at week 24, patients in both arms were eligible to receive Eylea 2mg on an as-needed basis through week 44. The primary endpoint of the study was the mean change at week 24 from baseline in best-corrected visual acuity (BCVA) as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart.
In this trial, patients receiving Eylea at an initial dose of 2mg, followed by treatment on an as-needed basis, had a mean improvement in BCVA from baseline at week 24 of 12.1 letters, compared to a loss of 2 letters in patients receiving sham injections (P<0.0001).
Eylea has already been approved 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.
For more information call (914) 345-7400 or visit www.eylea.com.