Slide 1: Presented at the Angiogenesis, Exudation, and Degeneration 2025 – Virtual Edition
Presented at the Angiogenesis, Exudation, and Degeneration 2025 – Virtual Edition, February 8, 2025
Slide 2: Disclosures
isclosures Domenico Lepore: Consultant for Bayer and Novartis * AS: Speaker for Allergan, Bayer, Novartis, and Roche; attended advisory boards: Apellis, Bayer, Novartis, and Roche; research: Bayer and Novartis; contributed to clinical trials: Bayer and Novartis; board of directors: SemaThera Inc. HN
Slide 3: FIREFLEYE next (NCT04015180) study design
FIREFLEYE next (NCT04015180) study design Treated in FIREFLEYE after 2:1 randomization at baseline Enrolled in FIREFLEYE next* Completed visit at 3 years of age Aflibercept 0.4 mg group Aflibercept 0.4 mg group Aflibercept 0.4 mg group Follow-up ongoing Veryl Seesetten bie wert n=75 n=66 n=60 (116 e
Slide 4: Baseline characteristics
Baseline characteristics Aflibercepto.4 m Total (n=66) (00) Male, % 54.5 50.0 53.0 (Sy Gestational age, w andd | 26w4q 22.1 26w0d +17 26w3di19 | Gestational age group, % <24 weeks 45 a8 6.0 84% of children had no ROP at 224 to <27 weeks 59.4 64.7 61.0 227 weeks 364 265 33.0 FIREFLEYE next study entr
Slide 5: Unfavorable structural outcomes, ROP recurrence, and treatment for ROP complications in FIREFLEYE next
Unfavorable structural outcomes, ROP recurrence, and treatment for ROP complications in FIREFLEYE next Unfavorable structural outcomes At any time until 2 years At any time until 3 years At any time until 2 years At any time until 3 years of chronologicalage of chronologicalage of chronologicalage o
Slide 6: Ophthalmic outcomes
Ophthalmic outcomes at 3 years of age anverceot 040 [ae No./Total No. (%) Ocular findings, eyes Nystagmus 4/116 (3.4) 2/58 (3.4) Absence of manifest strabismus 98/116 (84.5) 50/58 (86.2) Amblyopia 1/116 (0.9) 2/58 (3.4) Cataract 1/116 (0.9) 0 Optic nerve atrophy 2/116 (1.7) 0 Ability to fix and foll
Slide 7: Growth parameters
Growth parameters up to 3 years of age g | x = 10 = - zB 5 s s 3 | a 0 100 E .Z =z 76 = o x= 50 55 45 Head circumference (cm) 35 —Aflibercept 0.4 mg (n=66) -»-Laser (n=34) 12.7 10.6 17 125 64 7.4 92.5 68.4 63.2 6A 48.2 ALT 43.3 —$ SS ee 41.2 FIREFLEYE next 1 year of 2 years of 3 years of study entry
Slide 8: Adverse events (during FIREFLEYE next)
Adverse events (during FIREFLEYE next through 3 years of age) | Aflibercept0.4mg (n=66) [NITE aus Any AE, n (%) 59 (89.4) 29 (85.3) Ocular AEs 33 (50.0) 11 (32.4) Ocular AEs in eyes formerly treated in FIREFLEYE 32 (48.5) 10 (29.4) Systemic AES 56 (84.8) 29 (85.3) AEs related to aflibercept 0.4 mg 2
Slide 9: 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 (final results through 5 years of age expected for 2026) Through 3 years of chron
Slide 10: Thank you to all FIREFLEYE next patients, parents, caregivers, and investigators
Thank you to all FIREFLEYE next patients, parents, caregivers, and investigators Final results through 5 years of age are expected in 2026 For more information, please contact: Domenico Lepore domenico.lepore@unicatt.it World map showing FIREFLEYE next study site countries.