Aflibercept is now approved to treat 5 retinal conditions caused by ocular angiogenesis.
The FDA has approved aflibercept (EYLEA; Regeneron) for the treatment of retinopathy of prematurity (ROP) in preterm infants, making it the first pharmacologic treatment for the condition in preterm infants, according to a company press release announcing the approval. Also, aflibercept is now approved to treat 5 retinal conditions caused by ocular angiogenesis.
Severe ROP can develop in 1,100 to 1,500 US infants each year, affecting infants who are born prior to 31 weeks gestation or who weigh less than 3.3 lbs (1,500 g) at birth.
Because retinal blood vessels are mostly only completely developed when an infant reaches full term, preterm infants are at an increased risk of developing abnormal blood vessels that can lead to retinal detachment and irreversible vision loss. While mild cases can improve over time without treatment, other cases may need treatment to prevent ROP from worsening, including visual impartment and blindness.
“Retinopathy of prematurity is a leading cause of childhood blindness worldwide. Until now, the only FDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also the family navigating a delicate time after a preterm birth,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, and a principal inventor of [aflibercept]. “For the first time, physicians will now have an FDA-approved medication in [aflibercept] to treat this heartbreaking disease in these smallest of patients. We thank the investigators and the many families who participated in the clinical trials.”
This approval is backed by positive data from 2 phase 3 trials, FIREFLEYE and BUTTERFLEYE, which examined aflibercept 0.4 mg vs laser photocoagulation in infants with ROP. Data from both trials showed approximately 80% of patients in the aflibercept-treated group achieved an absence of active ROP and unfavorable structural outcomes at 52 weeks of age. Additionally, there were no new safety signals observed for aflibercept in either of the trials.
“With no existing FDA-approved guidance for the treatment of retinopathy of prematurity with anti-VEGF therapies, there was a significant need for research to understand how best to treat the disease in a manner that puts patient safety first and preserves vision for a lifetime,” said Jeff Todd, CEO, Prevent Blindness. “Regeneron’s trials investigating [aflibercept] in retinopathy of prematurity have advanced our understanding of how to treat this disease and provided a needed evidence-based treatment option to potentially help preterm infants preserve their vision.”
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