One-year outcomes of three-monthly and four-monthly loading regimens of faricimab for treatment-naïve neovascular age-related macular degeneration.

PURPOSE: To compare the efficacy of different loading doses of faricimab by comparing the outcomes following four-monthly and three-monthly loading regimens in neovascular age-related macular degeneration (nAMD).

METHODS: Patients diagnosed with treatment-naïve nAMD who received intravitreal injection of faricimab were retrospectively enrolled from clinical database at the Japanese Red Cross Wakayama Medical Center (JRCW) and Kyoto University Hospital (KUHP) between July 1, 2022, and April 31, 2023. Patients at JRCW and KUHP received four-monthly and three-monthly loading regimens, respectively. Changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), subfoveal choroidal thickness (SFCT), and dry macula ratio were evaluated before initial treatment, two months after the final injection in the loading phase (Month 2) and one year after the initial treatment (Year 1). Dosing intervals were determined based on disease activity two and three months after the final injection of the loading phase.

RESULTS: This study included 24 and 25 eyes in the three-dose and four-dose groups, respectively. BCVA, CMT, and SFCT significantly improved in both cohorts at Month 2 (all P < 0.01). After the loading phase, the doing intervals was similar between the two groups (P = 0.58). These improvements were sustained through Year 1 (all P < 0.01), with no significant differences in changes in BCVA, CMT, or SFCT between the groups at Year 1 (P = 0.58, 0.50, and 0.41, respectively).

CONCLUSIONS: Morphological and functional efficacy over one year was comparable between the four- and three-dose faricimab loading regimens.

KEY MESSAGES: What is known Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, is emerging as a promising therapeutic for neovascular AMD. Although a four-dose loading regimen was adopted in the pivotal TENAYA and LUCERNE trials, its superiority over the more conventional three-dose protocol remains uncertain in clinical practice. What is new In this study, we directly compared the four- and three-monthly loading regimens and found no significant differences in the dosing intervals and morphological and functional efficacy at 1 year. For both typical age-related macular degeneration and polypoidal choroidal vasculopathy, the dosing intervals and morphological and functional efficacy were comparable between the four- and three-monthly loading regimens.