Journal Article

Efficacy, durability, and safety of faricimab up to every 16 weeks in patients with neovascular age-related macular degeneration: 2-year results from the Japan subgroup of the phase III TENAYA trial

Honda, Shigeru, Gomi, Fumi, Koizumi, Hideki, Ochi, Haruka, Tsujikawa, Akitaka, Okada, Annabelle Ayame, Iwasaki, Keisuke, Mori, Ryusaburo

2024

Overview

Purpose To evaluate 2-year efficacy, durability, and safety of faricimab in the TENAYA Japan subgroup and pooled global TENAYA/LUCERNE cohort of patients with neovascular age-related macular degeneration (nAMD). Methods Subgroup analysis of TENAYA/LUCERNE (NCT03823287/NCT03823300): phase III, multicentre, randomised, active comparator–controlled, double-masked, non-inferiority trials. Treatment-naïve patients aged ≥ 50 years with nAMD were randomised (1:1) to intravitreal faricimab (6.0 mg up to every 16 weeks [Q16W] after 4 initial Q4W doses) or aflibercept (2.0 mg Q8W after 3 initial Q4W doses). Outcomes were assessed through year 2 for the TENAYA Japan subgroup ( N  = 133) and global pooled TENAYA/LUCERNE cohort ( N  = 1329). Results Vision and anatomic improvements achieved with faricimab at year 1 were maintained over 2 years and were generally comparable between the TENAYA Japan subgroup and pooled TENAYA/LUCERNE cohort. Adjusted mean best-corrected visual acuity (BCVA) change from baseline at year 2 for the TENAYA Japan subgroup and global pooled TENAYA/LUCERNE cohort was +7.1 (3.7–10.5) and +4.4 (3.2–5.5) letters in the faricimab arm, respectively, and +5.2 (1.9–8.6) and +4.3 (3.1–5.4) letters in the aflibercept arm, respectively. At week 112, the proportion of faricimab-treated patients on Q16W dosing was 61.0% and 63.1% in the TENAYA Japan subgroup and pooled TENAYA/LUCERNE cohort. Faricimab was well tolerated through year 2. Conclusion Year 2 TENAYA Japan subgroup findings for faricimab were generally consistent with the pooled global TENAYA/LUCERNE results in patients with nAMD. Vision and anatomical benefits with faricimab were similar to those with aflibercept but with fewer injections.

• Publisher: Springer Berlin Heidelberg,Springer Nature B.V
• Subject: Acuity / Age / Aged / Angiogenesis Inhibitors - administration & dosage / Angiogenesis Inhibitors - adverse effects / Clinical trials / Dose-Response Relationship, Drug / Double-Blind Method / Drug Administration Schedule / Female / Fluorescein Angiography / Follow-Up Studies / Humans / Intravitreal Injections / Japan - epidemiology / Macular degeneration / Male / Medicine / Medicine & Public Health / Middle Aged / Monoclonal antibodies / Ophthalmology / Receptors, Vascular Endothelial Growth Factor - administration & dosage / Receptors, Vascular Endothelial Growth Factor - antagonists & inhibitors / Recombinant Fusion Proteins - administration & dosage / Retinal Disorders / Time Factors / Tomography, Optical Coherence / Treatment Outcome / Vascular Endothelial Growth Factor A - antagonists & inhibitors / Vision / Visual Acuity / Wet Macular Degeneration - diagnosis / Wet Macular Degeneration - drug therapy / Wet Macular Degeneration - physiopathology