Author’s Name(s): Valérie Gagné, Mélanie Hébert, Jean-Philippe Rozon, Serge Bourgault, Mathieu Caissie, Laurence Letartre, Eric Tourville, Claudine Bellerive, Ali Dirani

Author’s Disclosure Block: Valérie Gagné: Bayer Roche, Employment/honoraria/consulting fees, Novartis, Employment/honoraria/consulting fees; Mélanie Hébert: none; Jean-Philippe Rozon: none; Serge Bourgault: none; Mathieu Caissie: none; Laurence Letartre: none; Eric Tourville: none; Claudine Bellerive: none; Ali Dirani: none

Abstract Body
Purpose: Faricimab (Vabysmo™) is a humanized bispecific immunoglobulin G1 (IgG1) antibody targeting both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). It was approved in Canada in August 2022 for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). This study aimed to evaluate the effects of faricimab on best-corrected visual acuity (BCVA), central macular thickness (CMT), and treatment intervals in patients with nAMD and DME in a real-world clinical setting. Study Design: Single-center retrospective cohort study Methods: The study included all consecutive patients receiving faricimab injections for nAMD or DME (n=334 eyes) between 2022 and 2024 at the Centre Oculaire de Québec. BCVA and CMT were assessed at the first, third, and last faricimab injections. The last treatment interval with faricimab was recorded. Data on prior anti-VEGF treatments, treatment-naïve status, and any switches to alternative therapies after faricimab were also collected. Results: Among the 334 eyes treated (7 injections [5, 9]) 66 eyes (20%) were treated for DME and 268 eyes (80%) were treated for nAMD. A total of 278 eyes (83%) had previously been treated with at least one other anti-VEGF therapy (14 injections [6, 40]). Between presentation and prior to switch, eyes had shown visual acuity stabilization BCVA (nAMD: 0.39 [0.22, 0.60] to 0.34 [0.20, 0.53]; p=0.06 and DME: 0.32 [0.22, 0.44] to 0.36 [0.22, 0.46]; p=0.52), and CMT had improved significantly (nAMD: -26 [-76, -4] μm; p<0.001 and DME -43 [-107, 22] μm; p=0.008) between their first and last injections of the previous anti-VEGF.After the switch, BCVA improved between the first and third injections (nAMD: 0.34 [0.20, 0.58] to 0.34 [0.17, 0.54]; p=0.009 and DME: 0.32 [0.16, 0.50] to 0.32 [0.14, 0.48]; p=0.02), with no further improvement between the third and last injections (nAMD: 0.32 [0.18, 0.56]; p=0.91 and DME: 0.32 [0.14, 0.45]; p=0.54). CMT significantly improved between the first and third injections (nAMD: -8 [-32, 1] μm; p<0.001 and DME: -34 [-85, 2] μm; p<0.001) and between the third and last injections (nAMD: -2 [-12, 6] μm; p=0.01 and DME: -12 [-41, 6] μm; p=0.007). The treatment interval for faricimab was extended for both nAMD patients (38 [28, 49] days to 49 [39, 63] days; p<0.001) and DME patients (35 [28, 49] days to 49 [40, 63] days; p=0.048). Conclusion: These real-world findings suggest that faricimab injections significantly improved BCVA and CMT in patients with nAMD and DME during the loading phase. Additionally, faricimab allows for extended treatment intervals compared to prior anti-VEGF therapies. Further studies are needed to assess long-term efficacy and optimize treatment protocols.