The FDA has authorised aflibercept (EYLEA; Regeneron) for the remedy of retinopathy of prematurity (ROP) in preterm infants, making it the primary pharmacologic remedy for the situation in preterm infants, in keeping with an organization press launch asserting the approval. Additionally, aflibercept is now authorised to deal with 5 retinal circumstances brought on by ocular angiogenesis.
Extreme ROP can develop in 1,100 to 1,500 US infants every year, affecting infants who’re born previous to 31 weeks gestation or who weigh lower than 3.3 lbs (1,500 g) at beginning.
As a result of retinal blood vessels are principally solely utterly developed when an toddler reaches full time period, preterm infants are at an elevated threat of creating irregular blood vessels that may result in retinal detachment and irreversible imaginative and prescient loss. Whereas delicate instances can enhance over time with out remedy, different instances may have remedy to stop ROP from worsening, together with visible impartment and blindness.
“Retinopathy of prematurity is a number one explanation for childhood blindness worldwide. Till now, the one FDA-approved remedy in widespread use was laser photocoagulation, a posh and prolonged process that completely ablates retina tissue and is disturbing not just for toddler sufferers but additionally the household navigating a fragile time after a preterm beginning,” mentioned George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, and a principal inventor of [aflibercept]. “For the primary time, physicians will now have an FDA-approved treatment in [aflibercept] to deal with this heartbreaking illness in these smallest of sufferers. We thank the investigators and the various households who participated within the medical trials.”
This approval is backed by constructive information from 2 section 3 trials, FIREFLEYE and BUTTERFLEYE, which examined aflibercept 0.4 mg vs laser photocoagulation in infants with ROP. Information from each trials confirmed roughly 80% of sufferers within the aflibercept-treated group achieved an absence of energetic ROP and unfavorable structural outcomes at 52 weeks of age. Moreover, there have been no new security indicators noticed for aflibercept in both of the trials.
“With no present FDA-approved steerage for the remedy of retinopathy of prematurity with anti-VEGF therapies, there was a major want for analysis to grasp how greatest to deal with the illness in a way that places affected person security first and preserves imaginative and prescient for a lifetime,” mentioned Jeff Todd, CEO, Stop Blindness. “Regeneron’s trials investigating [aflibercept] in retinopathy of prematurity have superior our understanding of tips on how to deal with this illness and offered a wanted evidence-based remedy choice to doubtlessly assist preterm infants protect their imaginative and prescient.”
EYLEA (AFLIBERCEPT) INJECTION APPROVED AS THE FIRST PHARMACOLOGIC TREATMENT FOR PRETERM INFANTS WITH RETINOPATHY OF PREMATURITY (ROP) BY THE FDA. Regeneron. February 8, 2023. Accessed February 13, 2023. https://investor.regeneron.com/news-releases/news-release-details/eylear-aflibercept-injection-approved-first-pharmacologic