Author’s Name(s): Wai-Ching Lam, Shih-Jen Chen, Gemmy Cheung, Tomohiro Iida, Adrian Koh, Won Ki Lee, Paisan Ruamviboonsuk, Xiaodong Sun, Yasuo Yanagi, Timothy Lai

Author’s Disclosure Block: Wai-Ching Lam: Roche, Grant/research support, Novartis, Membership on an advisory panel, standing committee or board of directors, Bayer, Employment/honoraria/consulting fees, Amgen, Membership on an advisory panel, standing committee or board of directors, Apellis, Membership on an advisory panel, standing committee or board of directors; Shih-Jen Chen: Financial Disclosures: Consultant; Gemmy Cheung: Consultant: Allergan, Bayer, Boehringer Ingelheim, Novartis, Roche, Samsung, Topcon; Tomohiro Iida: Consultant: Bayer, Boehringer Ingelheim, Chugai Pharmaceutical Co., Ltd./Roche, Novartis, Senju; Adrian Koh: Consultant: Alcon, AllerganonebbVie, Apellis, Bayer, Boehringer Mannheim, Heidelberg Engineering, Novartis, Santen, Topcon, ZEISS; Won Ki Lee: Consultant: Bayer, Novartis, Roche; Paisan Ruamviboonsuk: Consultant: Bayer, Novartis; Xiaodong Sun: none; Yasuo Yanagi: none; Timothy Lai: Funding: Allergan, Bayer, Novartis, Roche; Consultant: Allergan, Bayer, Boehringer Ingelheim, Novartis, Oculis, Roche

Abstract Body
Purpose: The phase 3 TENAYA /LUCERNEtrials in neovascular age-related macular degeneration (nAMD) demonstrated that dual inhibition of the angiopoietin-2/vascular endothelial growth factor-A pathways with faricimab resulted in 63% of patients achieving every 16-week (Q16W) dosing at week 112 with comparable vision gains and anatomic outcomes vs aflibercept Q8W. SALWEEN is a phase 3b/4 trial assessing the efficacy, durability, and safety of faricimab in patients with polypoidal choroidal vasculopathy (PCV), a frequent subtype of nAMD in Asia, where PCV represents up to 50% of the nAMD population, and a population underrepresented in TENAYA/LUCERNE. Methods: SALWEEN is a multicenter, open-label, single-arm, 108-week study of faricimab in patients from Asian countries with PCV. Patients with symptomatic macular PCV are administered intravitreal faricimab 6.0 mg Q8W, Q12W, or Q16W based on protocol-defined disease activity assessments at weeks 20 and 24 after 4 initial Q4W doses. At weeks 44/48 through 104, patients follow a protocol-driven treat-and-extend–based personalized treatment interval regimen, during which treatment intervals ranging from Q8W–Q20W are adjusted based on individualized treatment response, assessed by prespecified anatomical and functional criteria. The primary endpoint is change from baseline in best-corrected visual acuity (BCVA) based on an average of weeks 40, 44, and 48. Secondary endpoints, including visual and anatomic outcomes, durability, and safety, will be assessed through week 108. Results: Outcomes at week 16, after initial Q4W loading, will be reported, including changes from baseline in BCVA, central subfield thickness, the proportion of patients with resolution of fluid and complete regression of polypoidal lesions, and safety. Conclusions: SALWEEN is evaluating the efficacy, durability, and safety of faricimab in patients from Asian countries with PCV. The week 16 results, after initial Q4W loading dose, will provide important information on the early efficacy and safety of faricimab in this patient population.