Slide 1: Efficacy and safety outcomes at 5 years of age from the FIREFLEYE next study
Efficacy and safety outcomes at 5 years of age from the FIREFLEYE next study in children treated with intravitreal aflibercept 0.4 mg versus laser for retinopathy of prematurity (ROP) in the randomized FIREFLEYE study Presented at the ARVO 2026 congress, Denver, Colorado, May 3–7, 2026
Slide 2: FIREFLEYE next (NCT04015180) Study Design
FIREFLEYE next (NCT04015180) Study Design FIREFLEYE next was the first multinational, Phase 3b study to assess ocular and further clinical outcomes, including growth and neurodevelopmental outcomes, through 5 years of age following treatment of acute-phase ROP with intravitreal aflibercept 0.4 mg ve
Slide 3: Baseline Characteristics in FIREFLEYE next
Baseline Characteristics in FIREFLEYE next Aflibercept 0.4 mg Laser Total (N=66) (N=34) (N=100) Male, % 54.5 50.0 53.0 Gestational age, w 26w 4d ±2.1 26w 0d ±1.7 26w 3d ±1.9 Birth weight, g 882.2 ±286.9 819.5 ±238.6 860.9 ±271.9 Body weight at baseline treatment in FIREFLEYE, g 2045.8 ±675.8 1843.8
Slide 4: Primary Endpoint: Binocular BCVA at 5 Years of Age
Primary Endpoint: Binocular BCVA at 5 Years of Age Aflibercept 0.4 mg Laser (n=50) (n=28) 20/12.5 -0.2 20/16 -0.1 92% 75% 20/20 0.0 ≥20/40 ≥20/40 20/25 0.1 Primary Estimand: 20/32 0.2 The estimated probability that treatment initiation with aflibercept Snellen equivalent 20/40 0.3 resulted in better
Slide 5: Unfavorable Structural Outcomes and the Need for ROP Treatment in FIREFLEYE next
Unfavorable Structural Outcomes and the Need for ROP Treatment in FIREFLEYE next Aflibercept 0.4 mg (N=66) Laser (N=34) Between treatment Between treatment Between treatment Between treatment Between treatment Between treatment Unfavorable structural outcomes and 2 years of age and 3 years of age an
Slide 6: Ophthalmic Outcomes at 5 Years of Age
Ophthalmic Outcomes at 5 Years of Age No./Total No. (%) Aflibercept 0.4 mg Laser Ocular findings, patients Refractive spherical equivalent (D) Nystagmus 1/56 (1.8) 1/30 (3.3) Manifest strabismus 10/56 (17.9) 4/30 (13.3) 0 Ocular findings, eyes Cataract 1/108 (0.9) 0/58 (0) Optic nerve atrophy 3/108
Slide 7: Growth Parameters up to 5 Years of Age
Growth Parameters up to 5 Years of Age 30 Aflibercept 0.4 mg (N=66) Laser (N=34) 16.9 Mean body weight (kg) 20 12.7 14.7 10.6 10 6.7 7.7 14.9 17.2 No clinically relevant 10.2 12.5 0 6.4 7.4 differences in growth BL 1 year 2 Years 3 Years 4 Years 5 Years parameters were 125 100.3 106.8 84.0 92.5 obse
Slide 8: Neurodevelopmental Test Outcomes (VABS-II and WPPSI-IV) at 5 Years of Age
Neurodevelopmental Test Outcomes (VABS-II and WPPSI-IV) at 5 Years of Age Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) scores Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) scores Aflibercept 0.4 mg Laser Aflibercept 0.4 mg Laser 140 140 92.5 98.5 74.9 12
Slide 9: Adverse Events During FIREFLEYE next Through 5 Years of Age
Adverse Events During FIREFLEYE next Through 5 Years of Age Aflibercept 0.4 mg Laser (n=66) (n=34) Any AE, n (%) 62 (93.9) 29 (85.3) Ocular AEs 35 (53.0) 16 (47.1) Ocular AEs in treated eye 34 (51.5) 15 (44.1) Ocular AEs in untreated eye 2 (3.0) 1 (2.9) Systemic AEs 59 (89.4) 29 (85.3) AEs related t
Slide 10: Conclusions
Conclusions FIREFLEYE next is the first prospective, controlled, Phase 3b study evaluating long-term efficacy and safety outcomes after treatment of acute-phase ROP with aflibercept 0.4 mg versus laser photocoagulation Through 5 years of chronological age, efficacy outcomes were well sustained, and
Slide 11: Thank you to all FIREFLEYE next patients, parents, caregivers, and investigators
Thank you to all FIREFLEYE next patients, parents, caregivers, and investigators For more information, please contact: Domenico Lepore domenlepore@icloud.com UK Bulgaria Russian Belgium Hungary Federation Spain Ukraine Portugal Greece Italy Czechia Sweden Romania Republic of Korea Netherlands Türkiy