The U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept (Eylea; Regeneron) injection to treat retinopathy of prematurity (ROP) in preterm infants. The target action date for the FDA decision is February 11, 2023.
Data from 2 global Phase 3 trials investigating aflibercept 0.4 mg versus laser photocoagulation in infants with ROP in which approximately %80 of infants treated with aflibercept achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age, supported the acceptance.
The primary endpoint of non-inferiority was not met due to laser demonstrating comparable levels of efficacy that were higher than what has been historically observed in similar ROP trials.
Read the full press release here.
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