Real-world anatomical and functional outcomes following Faricimab therapy in neovascular age-related macular degeneration: a one-year observational study

Abstract

This study evaluated 12-month anatomical and functional outcomes of Faricimab in Italian patients with neovascular age-related macular degeneration (nAMD). 30 eyes from 30 participants who completed the 12-month follow-up were retrospectively analyzed at “Luigi Vanvitelli” University Eye Clinic (Naples) and “Rummo” Hospital Ophthalmology Unit (Benevento). All underwent best-corrected visual acuity (BCVA), spectral-domain optical coherence tomography (SD-OCT), and optical coherence tomography angiography (OCTA). Patients were stratified by anti-vascular endothelial growth factor (VEGF) treatment [naïve ( N  = 22); non-naïve ( N  = 8)], baseline macular neovascularization (MNV) type and fluid distribution. BCVA and central retinal thickness (CRT) were assessed at 6 and 12 months. The association between baseline subretinal hyperreflective material (SHRM) status and longitudinal BCVA and CRT was also investigated. The intravitreal injection number was similar between naïve and non-naïve eyes (median, 6 vs. 7; p  = 0.093). One adverse event (vitreitis with ocular hypertension) occurred. Mixed-effects modelling showed significant longitudinal improvements in BCVA from baseline to months 6 and 12, with no significant time-by-treatment-history interaction. Baseline retinal fluid distribution was not significantly associated with differences in BCVA changes, while baseline SHRM status showed a significant time-by-SHRM interaction for BCVA, although multiplicity-adjusted between-group comparisons were not significant at any time point. CRT decreased significantly from baseline to months 6 and 12, whereas the change between months 6 and 12 was not statistically significant. SHRM thickness also decreased significantly from baseline to months 6 and 12. Exploratory analyses by MNV subtype did not identify significant differences in 12-month BCVA or CRT. In exploratory multivariable analysis, baseline BCVA was the only factor significantly associated with 12-month BCVA, whereas age, previous anti-VEGF treatment, and baseline SHRM were not. This retrospective two-center study showed significant improvements in BCVA and CRT after 12 months of Faricimab, with no statistically detectable difference in longitudinal BCVA according to previous anti-VEGF exposure. Although baseline SHRM was associated with a significant time-by-SHRM interaction for BCVA, the absence of significant multiplicity-adjusted between-group differences limits interpretation of a differential response according to SHRM status. Given the small sample size and retrospective design, these findings should be interpreted cautiously.