Bayer Ag · XETR:BAYN
Bayer — 23rd European Society of Retina Specialists (EURETINA) Congress 2023
11 slides from Bayer's conference presentation, October 2023
Slide 1: Two-year outcomes from FIREFLEYE Next follow-up study in ROP
Two-year outcomes from FIREFLEYE Next, a prospective follow-up study to evaluate long-term efficacy and safety of patients treated with intravitreal aflibercept or laser photocoagulation for ROP in the FIREFLEYE study Presented at the 23rd European Society of Retina Specialists (EURETINA), Amsterdam
Slide 2: Disclosures
Disclosures Presenting Author Domenico Lepore: Consultant for Bayer and Novartis Co-author group AS: Consultant for Allergan, Apellis, Bayer, Novartis, and Roche; HN: Expenses from Bayer; W-CW: Consultant for Allergan; NA: Expenses from Bayer; CJ: Consultant for Bayer; RV, AA & KC: Employees of Rege
Slide 3: FIREFLEYE Next (NCT04015180) study design
FIREFLEYE Next (NCT04015180) study design FIREFLEYE Next is the first multinational, ongoing, phase 3b study assessing 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
Slide 4: Baseline characteristics
aseline characteristics Aflibercept0.4 mg Total (n=66) ( Male, n (%) 36 (54.5) 17 (50.0) 53 (53.0) (8 Gestational age, w andd 26w 4d 22.1 26w0ds1.7 26w3d21.9 Gestational age group, n (%) 9 i Od wecke 3145) 38.8) 6 (60) 84% of children had no ROP at 224 to <27 weeks 39 (59.1) 22 (64.7) 61 (61.0) FIRE
Slide 5: Unfavorable structural outcomes, ROP recurrence, and treatment for ROP complications
Unfavorable structural outcomes, ROP recurrence, and treatment for ROP complications in FIREFLEYE Next uU At any time until 1 year At any time until 2 years At any time until 1 year At any time until 2 years nfavorable structural outcomes a 5 of chronological age of chronological age of chronologica
Slide 6: Ophthalmic outcomes at 2 years of chronological age
Ocular findings at 2 years of chronological age, n (%) Nystagmus Manifest strabismus Amblyopia Cataract Optic nerve atrophy Ability to fix and follow a 5-cm toy Eyes with complete retinal vascularization, n (%)* At 1 year of chronological age At 2 years of chronological age — Ophthalmic outcomes at
Slide 7: Growth parameters up to 2 years of age
Growth parameters up to 2 years of age
Slide 8: Neurodevelopmental test outcomes at 2 years of age
Neurodevelopmental test outcomes at 2 years of age
Slide 9: Adverse events during FIREFLEYE Next
Adverse events (during FIREFLEYE Next through 2 years of age) Any AE, n (%) 53 (80.3) 27 (79.4) Ocular AEs 30 (45.5) 9 (26.5) Ocular AEs in eyes formerly treated in FIREFLEYE 29 (43.9) 9 (26.5) Systemic AEs 49 (74.2) 24 (70.6) AEs related to aflibercept 0.4 mg 1 (1.5) 1 (2.9) AEs related to laser tr
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 vs. laser photocoagulation (final results through 5 years of age expected for 2026) Through 2 years of chronolo
Slide 11: Thank you to all FIREFLEYE Next patients and investigators
Thank you to all FIREFLEYE Next patients and investigators
Bayer — 23rd European Society of Retina Specialists (EURETINA) Congress 2023 on 6ix