Eylea aflibercept ophthalmic solution: Phase III data
Top-line data from the double-blind, Asian Phase III MYRROR trial in 122 patients with myopic CNV showed that 2 mg intravitreal Eylea met the primary endpoint of improving BCVA as measured by the mean change from baseline on the ETDRS eye chart at week 24 vs. sham control (gain of 12.1 letters vs. a loss of 2 letters, p<0.0001). The most common adverse events reported were conjunctival hemorrhage, dry eye, eye pain, headache and nasopharyngitis. Patients in the Eylea arm were eligible to receive additional injections of the drug on an as-needed basis through 20 weeks, while patients in the sham control arm received monthly sham injections through week 20. Bayer, which has ex-U.S. rights to Eylea from Regeneron, plans to submit the first regulatory application for approval in the indication in Asia next half. ...