Key Clinical Outcomes With Faricimab in Treatment-naïve Patients With nAMD: Results From the TENAYA/LUCERNE Trials and Real-World FARETINA/FARWIDE Studies - 5581
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Author’s Disclosure Block: Rajinder Nirwan: Roche, Employment/honoraria/consulting fees; Robert L. Avery: Consultant: Adverum, Alcon, Alimera, Allergan, Amgen, Apellis, AsclepiX, Bausch + Lomb, Cardinal, Clearside Biomedical, Coherus, EyePoint, Genentech, Inc., Helio Vision, InFocus Capital Partners, Notal Vision, Novartis, NVasc, Ocular Therapeutix, Outlook, Pr3vent, Regenxbio, Replenish, Re-Vana, Santen, Tenpoint Therapeutics, Vial, Visionary Ventures; Stock: Adverum, Alcon, Aldeyra, EyePoint, InFocus Capital Partners, Iveric Bio, Kodiak Sciences, Novartis, NVasc, Outlook, Regeneron, Replenish, Re-Vana, Verana Health, Visionary Ventures.; Sara J. Haug: Genentech, Inc.; David Tabano: Employee: Genentech, Inc.; Gloria Chi: Employee: Genentech, Inc.; Manuel Amador: Employee: Genentech, Inc.; Aachal Kotecha: Employee: Roche Products Ltd.; Philippe Margaron: Employee: F. Hoffmann-La Roche Ltd.; Ming Yang: Employee: Genentech, Inc.
Abstract Body
Purpose: Faricimab treatment resulted in vision stability and tight anatomic control over 2 years, with a high proportion of patients on extended intervals based on protocol-defined disease activity. This summary highlights clinical pearls from the phase 3 TENAYA/LUCERNE trials and real-world FARETINA (US) / FARWIDE (UK) studies in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) treated with faricimab. Methods: In TENAYA/LUCERNE (NCT03823287/NCT03823300), patients (N=1,329) were randomized to faricimab 6.0 mg up to Q16W (n=665) after 4 initial Q4W doses, or aflibercept 2.0 mg Q8W (n=664). Faricimab-treated patients received Q8W–Q16W dosing until Week 60, followed by a treat-and-extend regimen. Dosing intervals were adjusted based on changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), or macular hemorrhage. Efficacy and safety were evaluated through Week 112. FARETINA and FARWIDE used EHR data from the AAO IRIS® Registry (US) and NHS Medisoft EHRs (UK). Patients initiating faricimab treatment from 2022–2023 were included. The analysis focused on treatment-naïve eyes, evaluating injection frequency, clinical outcomes, and prior treatment experience in those treated with faricimab for ≥12 months. Results: In TENAYA/LUCERNE, patients treated on ≥Q12W or only Q16W intervals achieved stable functional and anatomical outcomes, with over 50% meeting pre-specified criteria for Q20W dosing potential. Faricimab showed greater anatomical improvement (CST reduction, retinal fluid resolution, and PED thickness decrease) vs aflibercept during the head-to-head dosing phase. Faricimab was well tolerated over 2 years, with a safety profile similar to aflibercept. In treatment-naïve eyes with nAMD from FARETINA (n=2,368), the mean number of injections during Months 1–6 vs 7–12 was 4.1 vs 2.4, with a mean VA gain of +3.9 letters and CST improvement of -49.3 μm (p<0.001) after 12 months. In FARWIDE (n=176), the mean number of injections during Months 1–6 vs 7–12 was 4.7 vs 2.0, with a mean VA gain of +4.6 letters after 12 months. Conclusion: TENAYA/LUCERNE trials demonstrated robust disease control and extended durability with faricimab via dual Ang-2/VEGF-A inhibition. Faricimab showed greater anatomical improvements vs aflibercept, and patients on extended dosing intervals maintained stable outcomes, supporting further interval extension. Real-world data from FARETINA/FARWIDE confirm these results, showing improved VA, anatomical reductions, and early treatment extensions in treatment-naïve patients.