Inflammation and Occlusive Retinal Vasculitis Post Faricimab

Importance Randomized clinical trials have shown the safety and efficacy of faricimab as a novel vascular endothelial growth factor and angiopoietin-2 inhibitor in the treatment of neovascular age-related macular degeneration (nAMD) and macular edema of various etiologies. However, more rare adverse events may not be considered in clinical trials. Objective To describe 3 eyes that developed irreversible vision loss following initial mild intraocular inflammation (IOI) to faricimab. Design, Setting, and Participants This retrospective case series from a single academic tertiary referral center (University of Nebraska Medical Center) from October 2023 to August 2024 included 3 patients who developed occlusive retinal vasculitis (ORV) following an initial sensitization with intravitreal faricimab. Two eyes were being treated with faricimab for nAMD, and the other 2 eyes were treated for diabetic macular edema. Intervention Patients exposed to faricimab after the prior development of mild IOI. Main Outcomes and Measures Clinical symptoms, signs, and clinical course of patients who were diagnosed with ORV following rechallenge with faricimab. Results Mild IOI developed in 4 eyes following faricimab, and ORV developed in 3 eyes with repeated challenge. This resulted in profound, irreversible vision loss, despite treatment with topical and systemic steroids. In the eye that did not develop ORV following rechallenge, there have been no repeated adverse events despite restarting intravitreal faricimab injections. Conclusions and Relevance Given these observations with repeated challenge, caution is advisable when using the same biologic after the development of even mild IOI with prior injection. It appears an immunological memory response is elicited with these repeated exposures, resulting in the development of ORV.