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- Title
Efficacy, durability, and safety of faricimab up to every 16 weeks in patients with neovascular age-related macular degeneration: 1-year results from the Japan subgroup of the phase 3 TENAYA trial.
- Authors
Mori, Ryusaburo; Honda, Shigeru; Gomi, Fumi; Tsujikawa, Akitaka; Koizumi, Hideki; Ochi, Haruka; Ohsawa, Shino; Okada, Annabelle Ayame
- Abstract
Purpose: To evaluate the 1-year efficacy, durability, and safety of faricimab versus aflibercept in patients with neovascular age-related macular degeneration (nAMD) enrolled in the Japan subgroup of the TENAYA trial. Study design: TENAYA (NCT03823287) was a global, phase 3, multicenter, randomized, active comparator–controlled, double-masked, noninferiority, parallel-group, 112-week trial. After completion of global enrollment, additional patients were enrolled in the Japan extension of TENAYA. Methods: Treatment-naïve patients aged ≥ 50 years with nAMD were randomized (1:1) to intravitreal faricimab 6 mg up to every 16 weeks (Q16W) after 4 initial Q4W doses based on disease activity at weeks 20 and 24 or aflibercept 2 mg Q8W after 3 initial Q4W doses. Primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48. Anatomical/durability outcomes were assessed. Results: Overall, 133 patients were included in the TENAYA Japan subgroup analysis (faricimab, n = 66; aflibercept, n = 67). The adjusted mean (95% confidence interval) BCVA changes were + 7.1 (4.6‒9.7) and + 7.7 (5.2‒10.1) letters in the faricimab and aflibercept treatment groups, respectively. At week 48, 66.1%, 22.6%, and 11.3% of patients in the faricimab group were on Q16W, Q12W, Q8W and dosing intervals, respectively. Ocular adverse event rates were similar between treatment groups (faricimab, n = 14 [21.2%] versus aflibercept, n = 17 [25.4%]). Conclusion: The TENAYA Japan subgroup analysis showed that faricimab up to Q16W had sustained efficacy with an acceptable safety profile. These findings are consistent with the global TENAYA and LUCERNE findings.
- Subjects
MACULAR degeneration; CLINICAL trials; DURABILITY; VISUAL acuity; AFLIBERCEPT
- Publication
Japanese Journal of Ophthalmology, 2023, Vol 67, Issue 3, p301
- ISSN
0021-5155
- Publication type
Article
- DOI
10.1007/s10384-023-00985-w