EYLEA® (aflibercept) Injection sBLA for Treatment of Retinopathy of Prematurity (ROP) Accepted for FDA Priority Review

About this update from Regeneron Pharmaceuticals, Inc.

[{"type":"text","content":"ROP is a leading cause of childhood blindness worldwide\nTARRYTOWN, N.Y., Oct. 12, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection to treat Retinopathy of Prematurity (ROP) in preterm infants. The target action date for the FDA decision is February 11, 2023.\nROP is a leading cause of childhood blindness worldwide. Each year in the U.S., between 1,100 to 1,500 infants develop disease severe enough to require medical treatment. The rare eye disease often impacts infants who are born before 31 weeks of pregnancy have been completed or who weigh less than 1,500 grams (3.3 lbs) pounds at birth. As retinal blood vessels are often only fully developed when an infant is full-term (~9 months of pregnancy), these infants are at risk of developing retinal blood vessels that are abnormal (retinal neovascularization) potentially leading to retinal detachment and irreversible vision loss. Mild cases of ROP may get better without treatment, but some cases require treatment (for which the current standard of care is laser photocoagulation) to keep ROP from causing significant visual impairment and even blindness.\nThe sBLA is supported by data from two randomized global Phase 3 trials – FIREFLEYE (N=113) and BUTTERFLEYE (N=120) – investigating EYLEA 0.4 mg versus laser photocoagulation (laser) in infants with ROP. In both trials, approximately 80% of EYLEA-treated infants achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age, although their primary endpoint of non-inferiority was not met due to laser demonstrating comparable levels of efficacy that were higher than what have been historically observed in similar ROP trials. Notably, per an exploratory analysis, the time required to complete treatment administration per patient was considerably less for EYLEA than for laser (FIREFLEYE: 4 minutes versus 122 minutes; BUTTERFLEYE: 11 minutes versus 129 minutes).\nNo new EYLEA safety signals were observed in either trial. Comparing EYLEA to laser, ocular adverse events (AEs) among patients occurred in 39% versus 37% in FIREFLEYE and 18% versus 26% in BUTTERFLEYE, with serious ocular AEs occurring in 8% for both...

More updates from Regeneron Pharmaceuticals, Inc.