Aflibercept and laser therapy show comparable success rates in ROP

Treatment with intravitreal aflibercept 0.4 mg (IVT-AFL) demonstrates sustained absence of retinopathy of prematurity (ROP) through the first 2 years of a child’s life, while maintaining appropriate visual function, according to follow-up results from the FIREFLEYE Next study presented at AAO 2023. Moreover, there was no evidence of adverse effects on growth and neurodevelopmental outcomes at this age.

The study assessed the efficacy and safety outcomes up to the age of 5 years following the treatment of ROP using intravitreal aflibercept 0.4 mg (IVT-AFL) or laser photocoagulation, with participants randomly assigned in a 2:1 ratio.

The study, which reported outcomes at the age of 2 years, included 100 children in its Full Analysis Set (FAS) group. Among them, 66 received IVT-AFL treatment, while 34 underwent laser therapy. The children had a mean age of 9.0 ± 1.6 months at the start of the study.

Results at age 2 years revealed promising outcomes for both treatment groups. In the IVT-AFL group, 97% of children showed no signs of ROP, while the laser group demonstrated a commendable 94% success rate. Furthermore, 94% of children in both arms exhibited no unfavorable structural outcomes. There were no reported cases of retinal detachment.

In the IVT-AFL arm, 6% of children required treatment for ROP, with 2 cases addressing end-stage disease and 2 for reactivated bilateral disease. A small percentage of children in both groups (2% in IVT-AFL, 1 eye in laser) experienced challenges in fixating and following a 5-cm toy.

Importantly, there were no significant differences in growth and neurodevelopmental outcomes observed at 2 years of age between the IVT-AFL and laser treatment arms.

Reference
Stahl A, et al.Two-Year Outcomes From FIREFLEYE Next, a Prospective Long-Term Follow-Up Study After Treatment of ROP With Aflibercept vs. Laser. Presented at: AAO 2023.