INTRAOCULAR INFLAMMATION ASSOCIATED WITH FARICIMAB THERAPY: One-Year Real-World Outcomes.

Purpose: To report 1-year real-world evidence on intraocular inflammation (IOI) adverse events in patients undergoing faricimab therapy in a tertiary care hospital.

Methods: A retrospective review of electronic medical records was conducted for patients receiving faricimab treatment for neovascular age-related macular degeneration and diabetic macular edema at Moorfields Eye Hospital between September 1, 2022, and August 31, 2023. The primary outcome was the incidence of IOI (excluding endophthalmitis).

Results: Two thousand three hundred and eighteen eyes from 1,860 patients were included and underwent a total of 10,297 injections. A total of 20 eyes (16 patients) had ≥1 adverse event of IOI. Estimated incidence of IOI was 0.19% per injection (95% confidence interval, 0.12-0.30), 0.86% per eye (95% confidence interval 0.53-1.33), and 0.86% per patient (95% confidence interval, 0.49-1.39). Intraocular inflammation mostly occurred within the first injections (median 3.5 injections, range 1-10). All cases presented with anterior uveitis and were associated with vitritis in four eyes (20%). No cases of posterior uveitis or evidence of retinal vascular occlusion were reported. There was no statistically significant difference between the mean visual acuity before and after IOI event (0.40 and 0.378 logarithm of minimum angle of resolution, respectively, P = 0.26).

Conclusion: In this real-world report, faricimab was well tolerated with an incidence of IOI-related adverse events consistent to that observed in registration trials. The adverse events were generally mild and had a favorable prognosis.