Flexible Loading Phase Treat-and-Extend Regimen with Faricimab for Neovascular Age-Related Macular Degeneration: A Real-World Study

Background/Objectives: To evaluate the efficacy of a flexible loading-phase treat-and-extend regimen using faricimab, in which the number of initial injections was tailored to individual disease activity. Methods: This observational cohort study included 50 treatment-naïve eyes with neovascular age-related macular degeneration, treated with faricimab in Japan. Disease activity after one injection was assessed at the second visit (4 weeks later) to determine the treatment interval for subsequent injections. The primary outcome measure was the injection interval and visual/anatomical outcomes at 1 year after treatment initiation. Results: Overall, 43 of 50 eyes completed a 1-year follow-up. The mean logarithm of the minimum angle of resolution best-corrected visual acuity improved from 0.35 ± 0.32 to 0.19 ± 0.3 at the 1-year follow-up. Overall, 60.5% achieved 16-week intervals, and 74.4% reached intervals of ≥12 weeks. A shorter loading phase (two or three injections) was associated with fewer total injections and higher rates of fluid resolution, without compromising visual outcomes. The presence of polypoidal choroidal vasculopathy and ellipsoid zone disruption were identified as risk factors for failure to extend treatment intervals beyond 16 weeks. Conclusions: A flexible loading-phase treat-and-extend regimen using faricimab yields outcomes comparable to those of the TENAYA protocol, with fewer injections. This simple approach is straightforward in design and may reduce treatment burden while maintaining efficacy.