Long-term efficacy and safety of ROP treatments: Insights from the FIREFLEYE trial

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Intravitreal aflibercept injections for the treatment of severe acute-phase retinopathy of prematurity (ROP) are as effective and safe as laser therapy in the long term, according to a study.

In the FIREFLEYE trial, the 2-year ophthalmic and safety outcomes in children treated with a 0.4-mg aflibercept injection or laser therapy were evaluated. Participants were previously treated with aflibercept injections or laser therapy for severe acute-phase ROP and had been born very or extremely preterm (gestational age ≤32 weeks) or with very or extremely low birth weight (≤1500 g).

Key findings from the study, include:

  • At 2 years of age, 96.8% of children in the aflibercept group and 93.8% in the laser group had no ROP.
  • Unfavorable structural outcomes were absent in 93.9% of the aflibercept group and 94.1% of the laser group.
  • No new cases of retinal detachment were reported.
  • Treatment for ROP complications was required for 6.1% of children in the aflibercept group before 1 year of age, primarily due to preexisting conditions or recurrent disease.
  • High myopia was less prevalent in the aflibercept group (7.8%) compared to the laser group (21.7%).
  • Most children in both groups could fix and follow a 5-cm toy, indicating good visual function.
  • There were no significant differences in growth and neurodevelopmental outcomes between the 2 groups.

No adverse effects on growth and neurodevelopment were identified, supporting the use of intravitreal aflibercept injection as a viable treatment option for ROP.

Stahl A, Nakanishi H, Lepore D, et al; FIREFLEYE next Study Group. Intravitreal Aflibercept vs Laser Therapy for Retinopathy of Prematurity: Two-Year Efficacy and Safety Outcomes in the Nonrandomized Controlled Trial FIREFLEYE next. JAMA Netw Open. 2024;7(4):e248383. doi: 10.1001/jamanetworkopen.2024.8383. PMID: 38687481; PMCID: PMC11061767.