FDA Approves EYLEA® (Aflibercept) for Treatment of Retinopathy of Prematurity

On February 8, 2023, Regeneron announced that the FDA approved its EYLEA® (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants—the first pediatric approval for this indication. Regeneron reported that the approval is supported by data from FIREFLEYE and BUTTERFLEYE—two phase III clinical trials comparing 0.4 mg EYLEA® to laser photocoagulation in infants with ROP. Regeneron reported that “[i]n both trials, approximately 80% of EYLEA-treated infants achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age, which is better than would have been expected without treatment.” Regeneron noted that this is the fifth approved indication for EYLEA®.