FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants


The FDA has assigned a target action date of Feb. 11, 2023.

The FDA has accepted for priority review the supplemental biologics license application (sBLA) for Eylea (aflibercept) injection to treat patients with retinopathy of prematurity (ROP) in preterm infants. The target action date for the FDA decision is Feb. 11, 2023. Retinopathy of prematurity is a leading cause of blindness in children, and each year between 1,100 and 1,500 infants develop the disease.

Developed by Regeneron, Eylea is currently available to treat patients with age-related macular degeneration, diabetic macular edema and diabetic retinopathy. It is a VEGF inhibitor that is injected into the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye

The supplemental application is supported by data from two phase 3 trials comparing Eylea with laser photocoagulation in infants. In both trials, about 80% of Eylea-treated infants achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age. But the primary endpoint of non-inferiority in both trials was not met because laser treatment demonstrated comparable levels of efficacy. No new safety signals were observed in either trial.

The results of one study, FIREFLEYE, were published in theJournal of the American Medical Association. Bayer conducted this study, which has marketing rights outside the United States.

Related: FDA Accepts sBLA for Eylea in Diabetic Retinopathy

Eylea is also under review for an additional dosing regimen with a longer-term interval between doses in patients with diabetic retinopathy. The target action date for this decision is Feb. 28, 2023.

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