Three-Year Outcomes of Intravitreal Aflibercept versus Laser Therapy for Retinopathy of Prematurity: Interim Analysis of the Efficacy and Safety Outcomes in the FIREFLEYE next Trial

Introduction: FIREFLEYE next 3 years of age efficacy and safety outcomes after intravitreal aflibercept 0.4 mg injection versus laser therapy for retinopathy of prematurity (ROP) in the randomized, FIREFLEYE trial are reported. METHODS: Children born prematurely (gestational age ≤32 weeks) or with low birth weight (≤1,500 g) were treated for ROP in FIREFLEYE. Efficacy and safety end points for this prespecified interim analysis included ROP status, unfavorable structural outcomes, disease recurrence, treatment of ROP complications, vascularization completion, visual function, adverse events, and growth outcomes. RESULTS: One hundred children were enrolled (aflibercept, 66 [128 eyes]; laser, 34 [64 eyes]). Data for the 3-year analysis were available for 90 children (aflibercept, 60; laser, 30). Most children had no ROP or unfavorable structural outcomes (aflibercept, 98.3% and 93.9% vs. laser, 96.7% and 94.1%), with no ROP reactivation after age 50 weeks. Two children (aflibercept) with re-activated disease received bilateral laser treatment prior to age 50 weeks. Most children could fix and follow a 5-cm toy (aflibercept, 96.6%; laser, 98.3% of eyes). Binocular best-corrected visual acuity (Snellen equivalent) was ≥20/200 and ≥20/40 in 97.8% and 66.7% (aflibercept) versus 100% and 47.8% (laser) of children, respectively. High myopia was present in 8.9% (aflibercept) and 24.1% (laser) of eyes. Adverse events and growth outcomes were as expected for the population. CONCLUSION: Descriptive analyses of the 3-year outcomes confirm long-term, stable disease control following aflibercept 0.4 mg treatment of severe acute-phase ROP, with age-appropriate visual function, less frequent/severe myopia compared with laser, and no ocular or systemic safety concerns. .