FDA Approves Regeneron’s Eylea for Infants With ROP

The FDA has approved Regeneron’s Eylea (aflibercept) as the first injection to treat preterm infants with retinopathy of prematurity (ROP).

Previously, the only FDA-approved treatment in common use for ROP was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue.

The FDA approval was supported by data from two phase 3 trials investigating Eylea versus laser photocoagulation in infants with ROP. In both trials, approximately 80 percent of Eylea-treated infants achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age.

Approved to treat four other retinal conditions caused by the formation of new blood vessels, Eylea has been used off label for about a decade to treat ROP, a vision-threatening disease of the incompletely vascularized, immature retina of infants born earlier than 37 weeks of gestational age.

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee struggled to find definitive answers when it met last month to consider dosing and labeling for Eylea as a treatment for ROP.