The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection for the treatment of retinopathy of prematurity (ROP) in preterm infants.

The sBLA is supported by data from the randomized, controlled, global phase 3 FIREFLEYE (N=113; Identifier: NCT04004208) and BUTTERFLEYE (N=120; Identifier: NCT04101721) trials, which evaluated the efficacy and safety of aflibercept in infants with ROP. Patients were randomly assigned to receive 0.4mg of aflibercept via intravitreal injection or laser photocoagulation. The primary endpoint was the proportion of patients with absence of active ROP and unfavorable structural outcomes. 

Findings from both trials showed that approximately 80% of patients who received aflibercept achieved an absence of active ROP and unfavorable structural outcomes at 52 weeks of age. However, the trials failed to meet the primary endpoint of noninferiority due to laser photocoagulation achieving comparable levels of efficacy, which were higher than previously seen in similar ROP trials.

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In the aflibercept and laser treatment arms, the incidence of ocular adverse events were 39% vs 37%, respectively, in FIREFLEYE and 18% vs 26%, respectively, BUTTERFLEYE; serious ocular adverse events occurred in 8% of patients in both arms in FIREFLEYE and 6.5% vs 11%, respectively, in BUTTERFLEYE.

In an exploratory analysis, treatment with aflibercept was found to require significantly less time to complete vs laser photocoagulation (FIREFLEYE: 4 minutes vs 122 minutes; BUTTERFLEYE: 11 minutes vs 129 minutes).

The FDA is expected to make a decision on the application on February 11, 2023.

Aflibercept, a vascular endothelial growth factor inhibitor, is currently marketed under the trade name Eylea® for the treatment of adults with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.


Eylea® (aflibercept) injection sBLA for treatment of retinopathy of prematurity (ROP) accepted for FDA Priority Review. News release. Regeneron Pharmaceuticals, Inc. Accessed October 12, 2022.

This article originally appeared on MPR