Real‐world incidence and clinical characteristics of intraocular inflammation following intravitreal faricimab therapy: A safety study

Abstract Purpose To estimate the real‐world incidence of intraocular inflammation (IOI) following intravitreal faricimab injections at a large, highly specialized tertiary centre. Methods Single‐centre, retrospective cohort study with chart review using an electronic injection database and electronic medical records from November 2023 to August 2024. Results The study included 6054 patients, 7510 eyes and 31 393 injections. During the inclusion period, 42 eyes of 40 patients developed IOI, resulting in 48 IOI events. The incidence of IOI was 0.66% per patient, 0.56% per eye and 0.13% per injection. IOI occurred after a median of 4 faricimab injections (IQR: 2, range: 1–9) and a median of 8.5 days (IQR: 20, range: 0–37) after the last injection. The median disease duration (time from diagnosis to resolution) was 32 days (IQR: 46, range: 6–144). Eighty per cent of patients who developed IOI were females, and females had 2.42–2.66 times higher hazard of developing IOI than males. Most IOI cases were anterior or anterior + intermediate uveitis (47.9% and 33.3%, respectively). All panuveitis cases ( n = 6) underwent vitrectomy, and one had a positive culture, yielding a 0.003% per‐injection incidence of culture‐positive endophthalmitis. Cases rechallenged with faricimab following IOI ( n = 13) had a relapse in 46.15%. The change in median best‐corrected visual acuity between before and after IOI events was not statistically significant. Conclusions Faricimab demonstrated an acceptable safety profile in our study. The incidence of IOI events was consistent with those observed in other real‐world reports. The IOI events showed a female predominance, varied presentations and durations, but generally had favourable outcomes. Study Registration ClinicalTrials.gov registration number: NCT06902207, Date of registration: 15/03/2025 retrospectively registered.