Aflibercept for ROP Shows Sustained Efficacy at Age 3

TOPLINE: 

A 0.4 mg dose of aflibercept in infancy to treat retinopathy of prematurity (ROP) shows sustained efficacy and safety at 3 years of age, according to research presented at EURETINA 2024. No significant ocular or systemic safety concerns were identified during follow-up, and retinal vascularization appeared complete in 80% of eyes by age 2 years.

METHODOLOGY:

• Researchers conducted an interim analysis of data from the FIREFLEYE next study, which is following participants in a randomized controlled trial that compared aflibercept vs laser photocoagulation in children with ROP.
• A total of 113 children were enrolled in the original FIREFLEYE trial, 100 continued on to FIREFLEYE next, and 90 completed a visit at age 3.
• Primary outcomes included the absence of active ROP, unfavorable structural outcomes, and completion of retinal vascularization.

TAKEAWAY:

• Disease reactivation after aflibercept treatment has not occurred beyond age 50 weeks, according to the investigators
• Visual function was age-appropriate, and myopia was less common and less severe among children who received aflibercept. High myopia was reported for 9% of the aflibercept group vs 24% of the group that received laser therapy.
• At age 3 years, one patient who received aflibercept showed retinal detachment following progression of a previously identified macular fold.
• “No clinically relevant differences in growth parameters were observed between both groups through 3 years of chronological age, and results are in line with what is expected in this prematurely born pediatric population,” according to the investigators.

IN PRACTICE:

“Overall, aflibercept 0.4 mg injection therapy in very/extremely preterm or very low birthweight patients with acute-phase ROP (as approved) was effective and generally well tolerated through 3 years of age,” the authors reported.

SOURCE:

Andreas Stahl, MD, with University Medicine Greifswald in Greifswald, Germany, presented the results September 20.

LIMITATIONS: 

The study is ongoing and will follow participants to age 5 years. Final results are expected in 2026. 

DISCLOSURES:

The study was sponsored by Bayer, which participated in the design, conduct, and analysis of the study. Some of the authors disclosed consulting for Bayer and other pharmaceutical companies, and others were employees of Bayer and Regeneron.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.