(B-287) Incidence of Intraocular Inflammation Following Faricimab Treatment: A Real-World Evidence

Background: Faricimab is an inhibitor of vascular endothelial growth factor (VEGF) and angiopoietin-2, demonstrating efficacy and reduced treatment burden in DME and AMD through extended dosing intervals. Clinical trials and real-world data have shown Faricimab to be safe, with intraocular inflammation (IOI) occurring in only 0.2% to 0.6% of patients.

Objectives: The aim of this study is to assess the risk of IOI associated with Faricimab use across patients diagnosed with age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and polypoidal choroidal vasculopathy (PCV).

Methods: This study was a retrospective, observational analysis of patients diagnosed with neovascular retinal diseases, including AMD, DME, PCV, and RVO. Data were collected from multiple ophthalmology practices from the TriNetX network between January 1, 2024, and April 30, 2025,. Adult patients (≥20 years) with a confirmed diagnosis of any of these conditions were eligible for inclusion if they had comprehensive clinical records and a minimum follow-up period of one year. Patients receiving investigational treatments outside the standard of care were excluded from the analysis. Exposures and Interventions: The study focused on the use of Faricimab. Primary Outcome: The primary outcome was the incidence of IOI in each disease group (AMD, DME, PCV, and RVO). IOI was identified using the following ICD-10 codes: H20.0, H35.06, H05.00, H20.9, and H30.2.

Results: A total of 7,784 patients were included: 4,085 with nAMD, 1,456 with DME, 1,057 with RVO, and 1,166 with PCV. The mean age ranged from 65.5 ± 10.8 years in the DME cohort to 75.6 ± 9.7 years in the nAMD cohort, and prior anti-VEGF exposure exceeded 50% in each group. The 180-day incidence of new-onset IOI was 0.54% (22/4,085) for nAMD, 1.24% (18/1,456) for DME, 1.21% (13/1,057) for RVO, and 1.03% (12/1,166) for PCV.

Conclusions: In this real-world, multi-institutional cohort study, the incidence of IOI following
faricimab administration was low, although slightly higher in patients with DME and RVO. Continued pharmacovigilance is warranted, particularly in patients with prior anti-VEGF exposure. These findings provide a foundation for the timely assessment of adverse drug reactions associated with new drugs in ophthalmology.