Author’s Name(s): Andrei-Alexandru Szigiato, Christiana Dinah, Francis Abreu, Pablo Arrisi, Aachal Kotecha, Ying Liu, Liliana Paris, Anne-Cecile Retiere, Jeffrey Willis

Author’s Disclosure Block: Andrei-Alexandru Szigiato: Apellis, Employment/honoraria/consulting fees, Roche, Employment/honoraria/consulting fees; Christiana Dinah: Consultancy: AbbVie, Apellis, Boehringer Ingelheim, Janssen, Ora Clinical, Roche; Lecture fees: Apellis, Roche, Topcon; Institution Grants: Apellis, NIHR, Roche, Topcon; Francis Abreu: Employee: Genentech, Inc. ; Pablo Arrisi: Employee: Roche Products Ltd. ; Aachal Kotecha: Employee: Roche Products Ltd.; Ying Liu: Employee: Genentech, Inc.; Liliana Paris: Employee: Genentech, Inc. ; Anne-Cecile Retiere: Employee: Roche Products Ltd. ; Jeffrey Willis: Employee: Genentech, Inc.

Abstract Body
Purpose:Faricimab is a dual angiopoietin-2/vascular endothelial growth factor-A (Ang-2/VEGF-A) inhibitor and the first bispecific antibody designed for intraocular use. Week 24 results from the phase 3 BALATON and COMINO trials support the efficacy and safety of faricimab for the treatment of macular edema due to retinal vein occlusion (RVO). Here we present a summary of the week 72 results from these trials and a selection of case profiles for patients treated through week 72. Methods: From day 1 through week 20, patients received 6 monthly intravitreal injections of faricimab 6.0 mg or aflibercept 2.0 mg. The primary endpoint was change in best-corrected visual acuity (BCVA) from baseline at week 24. From week 24 through 72, all patients received faricimab 6.0 mg per a modified treat-and-extend (T&E)–based dosing regimen where dosing intervals were adjusted from every 4 weeks (Q4W) to Q16W based on changes in central subfield thickness (CST) and BCVA at active dosing visits. Results: Overall, 553 and 729 patients were enrolled in BALATON and COMINO, respectively. Adjusted mean BCVA gains and CST reductions achieved at week 24 were maintained through week 72. Adjusted mean (95.03% confidence interval [CI]) BCVA changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab and prior aflibercept arms were +18.1 letters (16.9, 19.4) and +18.8 letters (17.5, 20.0) in BALATON and +16.9 letters (15.2, 18.6) and +17.1 letters (15.4, 18.8) in COMINO, respectively. Adjusted mean (95.03% CI) CST changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab and prior aflibercept arms were −310.9 μm (−315.6, −306.3) and −307.0 μm (−311.7, −302.3) in BALATON and −465.9 μm (−472.5, −459.3) and −460.6 μm (−467.2, −453.9) in COMINO, respectively. At week 68 in the prior faricimab and prior aflibercept arms, 64.1% and 56.9% of patients in BALATON and 45.5% and 50.1% in COMINO were on ≥ Q12W dosing. Faricimab was well tolerated from week 24-72, with no change in safety profile. Representative cases and associated retinal images illustrating the translation of anatomical outcomes to extended durability will be presented for patients treated through week 72 of the trials. Conclusion: Following positive 24-week results, 72-week results from BALATON and COMINO demonstrated longer-term efficacy and safety of faricimab in patients with RVO. Importantly, disease control was achieved during modified T&E dosing with more than 45% of patients achieving extended dosing intervals at week 68. Faricimab was well tolerated during modified T&E dosing.