The FDA approved Eylea for the treatment of retinopathy of prematurity in preterm infants, according to a press release from Regeneron.
The approval is supported by data from the phase 3 FIREFLEYE and BUTTERFLEYE trials, which investigated Eylea 0.4 mg (aflibercept, Regeneron) vs. laser photocoagulation in 233 infants with ROP. In both trials, approximately 80% of infants treated with Eylea achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age, the release said.
There were no new reported safety signals for Eylea, with ocular (Read more...)