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# Eylea Approved for Infants with Retinopathy
- URL: https://www.fdaweb.com/eylea-approved-for-infants-with-retinopathy/
- Published: 2023-02-09T12:00:00.000Z
- Updated: 2026-09-14T18:15:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153742

FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat preterm infants with retinopathy of prematurity (ROP). With this approval, the drug is now indicated to treat five retinal conditions caused by ocular angiogenesis.

“Retinopathy of prematurity is a leading cause of childhood blindness worldwide,” the company says. “ 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.”

The approval is based on data from two randomized global Phase 3 trials – FIREFLEYE (N=113) and BUTTERFLEYE (N=120) that assessed the drug versus laser photocoagulation. “In both trials, approximately 80% of Eylea-treated infants achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age, which is better than would have been expected without treatment,” the company says.

Regeneron describes Eylea as a VEGF inhibitor formulated as an injection for the eye. It works by blocking the growth of new blood vessels and decreasing the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor, two growth factors associated with ocular angiogenesis.