The Evolving Landscape of ROP Treatment

Clinicians have significantly improved the management of severe retinopathy of prematurity (ROP) with the advent of anti-vascular endothelial growth factor (VEGF) therapy. Specifically, aflibercept in ROP has emerged as a promising tool for experts dealing with aggressive posterior disease. This agent acts as a potent VEGF trap with high binding affinity. Consequently, it offers prolonged intraocular activity compared to shorter-acting medications. Many researchers believe these unique properties help reduce the risk of late disease recurrence while preserving peripheral retinal tissue.

Benefits and Clinical Evidence for Aflibercept in ROP

Recent clinical investigations have provided valuable insights into the efficacy of this treatment. Early retrospective studies utilized a 1 mg dose, which resulted in rapid regression of the disease. Furthermore, patients treated with aflibercept often experienced better refractive outcomes than those receiving laser therapy. Following these early findings, the pivotal FIREFLEYE and BUTTERFLEYE randomized controlled trials evaluated a lower 0.4 mg dose. These studies demonstrated that aflibercept achieves comparable treatment success to laser photocoagulation. Additionally, the drug preserves the peripheral retina and lowers the incidence of high myopia in growing infants.

Safety and Surveillance Requirements

While the benefits are clear, practitioners must remain vigilant regarding late complications. Reactivation of ROP after aflibercept treatment typically occurs less frequently and later than with ranibizumab. However, persistent avascular retina remains a primary concern for many neonatologists and ophthalmologists. Therefore, infants require prolonged surveillance to monitor for potential recurrence. If the disease returns, clinicians may use adjunctive laser treatment to ensure stable outcomes. Systemic safety data currently appear reassuring. Short-term studies show no significant adverse effects on growth or neurodevelopmental milestones for these vulnerable infants.

Frequently Asked Questions

What was the primary finding of the FIREFLEYE and BUTTERFLEYE trials regarding aflibercept in ROP?

These trials showed that a 0.4 mg dose of aflibercept provides comparable treatment success to laser photocoagulation. Furthermore, infants treated with aflibercept showed lower rates of high myopia and better preservation of the peripheral retina.

How does the recurrence rate of aflibercept compare to other anti-VEGF agents?

Reactivation following aflibercept typically occurs less frequently and later than with ranibizumab. Moreover, its recurrence rate is similar to or lower than that of bevacizumab, though long-term surveillance remains essential for all treated patients.

Disclaimer: This content is for informational and educational purposes only and does not constitute medical advice. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition. Refer to the latest local and national guidelines for clinical practice.

References

1. Kumawat D et al. Current role of aflibercept in retinopathy of prematurity - A review. Indian J Ophthalmol. 2026 May 01. doi: 10.4103/IJO.IJO_3323_25. PMID: 42060356.


2. Stahl A, et al. Aflibercept versus laser photocoagulation for retinopathy of prematurity: the FIREFLEYE randomized clinical trial. JAMA. 2022;328(15):1510-1520.


3. Regeneron Pharmaceuticals. FDA accepts for priority review the sBLA for EYLEA (aflibercept) to treat retinopathy of prematurity. Press Release. 2022.