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Home > Retinopathy of Prematurity > Three-year FIREFLEYE outcomes reported for aflibercept vs laser in ROP

Three-year FIREFLEYE outcomes reported for aflibercept vs laser in ROP

Ophthalmology 360
1 Min Read

Key Takeaways

  1. Most children in both treatment groups had no ROP or unfavorable structural outcomes at 3 years, with no disease reactivation after 50 weeks of age.
  2. Visual function outcomes were largely comparable between groups, while high myopia was reported less frequently in aflibercept-treated eyes than in laser-treated eyes.
  3. No new ocular or systemic safety issues were identified, and growth outcomes were consistent with expectations for this population.

Children treated with intravitreal aflibercept 0.4 mg for retinopathy of prematurity (ROP) maintained stable disease control and age-appropriate visual function through 3 years, with fewer cases of high myopia and no new safety concerns compared with laser therapy, according to results from the FIREFLEYE trial.

The trial enrolled 100 children born prematurely (gestational age ≤32 weeks) or with low birth weight (≤1,500 g) who required treatment for ROP. Of these, 66 children (128 eyes) were assigned to aflibercept and 34 children (64 eyes) to laser therapy.

Data for the prespecified 3-year interim analysis were available for 90 children (60 aflibercept; 30 laser).

At 3 years, most children in both groups had no ROP and no unfavorable structural outcomes (aflibercept: 98.3% and 93.9%; laser: 96.7% and 94.1%). No ROP reactivation was observed after 50 weeks of age. Two children in the aflibercept group experienced reactivated disease before 50 weeks and were treated with bilateral laser therapy.

Visual function outcomes were similar between groups. The majority of eyes were able to fix and follow a 5-cm toy (aflibercept, 96.6%; laser, 98.3%). Binocular best-corrected visual acuity was ≥20/200 in 97.8% of children treated with aflibercept and 100% treated with laser, and ≥20/40 in 66.7% and 47.8% of children, respectively. High myopia was reported in 8.9% of aflibercept-treated eyes compared with 24.1% of laser-treated eyes.

Adverse events and growth outcomes were reported to be consistent with expectations for this patient population.

Reference
Stahl A, Nakanishi H, Lepore D, et al. Three-year Outcomes of Intravitreal Aflibercept versus Laser Therapy for Retinopathy of Prematurity. Neonatology. 2026;1-19. doi: 10.1159/000549717. Epub ahead of print. PMID: 41505377.

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