In an abstract presentation at Euretina 2024, an interim analysis from the FIREFLEYE next study reported positive long-term efficacy and safety outcomes for children with retinopathy of prematurity who were treated with intravitreal aflibercept.

This ongoing multinational study assessed 100 children from the original FIREFLEYE trial over 3 years and compared intravitreal aflibercept (2 mg) with laser therapy. Visual function was evaluated using binocular best-corrected visual acuity (BCVA) assessments. Refractive outcomes, including the presence of myopia, were measured through standard ophthalmic exams. Safety and efficacy outcomes were assessed for disease control and development of high myopia in both the aflibercept and laser groups over a 3-year period.

At 3 years, 98.3% of aflibercept patients and 96.7% of laser patients had no retinopathy of prematurity. Binocular BCVA was ≥20/40 in 66.7% of aflibercept patients vs. 47.8% of laser patients, and at 8.9%, high myopia was significantly lower in the aflibercept group compared to the 24.1 % rate for laser-treated eyes.

No other systemic safety concerns were identified. Full data at 5 years is expected in 2026.

The presented abstract from Euretina 2024 and a full list of author disclosures can be found here.