A retrospective case series from the University of Nebraska Medical Center has revealed concerning outcomes in patients rechallenged with faricimab (Vabysmo) after experiencing initial inflammatory reactions. The study documented three cases where patients developed severe occlusive retinal vasculitis following repeated exposure to the drug, resulting in irreversible vision loss.
Clinical Observations and Patient Outcomes
The investigation, led by Christopher D. Conrady, MD, PhD, at the Truhlsen Eye Center, followed four eyes that initially developed mild intraocular inflammation after faricimab injections. Upon rechallenge, three of these eyes progressed to occlusive retinal vasculitis, despite aggressive treatment with topical and systemic steroids.
The case series included three patients treated between October 2023 and August 2024:
- An 89-year-old woman with neovascular age-related macular degeneration (nAMD)
- An 86-year-old woman being treated for nAMD
- A 63-year-old man with diabetic macular edema
Safety Implications and Clinical Recommendations
"In cases where inflammation develops from any anti-VEGF medication, we would recommend not rechallenging the patient with the same drug," emphasized Dr. Conrady. "While it may be okay in some patients, the risk of really bad complications -- blindness -- is real."
The findings add to growing evidence of rare but serious adverse events associated with faricimab use. Recent reports from Swiss and French research teams have documented similar cases of retinal vasculitis and severe intraocular inflammation following faricimab treatment.
Mechanism and Context
Faricimab, approved by the FDA in 2022 for nAMD and diabetic macular edema treatment, is a humanized, bispecific, immunoglobulin G monoclonal antibody. The observed inflammatory response pattern suggests an immune-mediated mechanism similar to vaccine reactions, where subsequent exposure triggers a more vigorous immune response.
Dr. Ghazala O'Keefe from Emory University School of Medicine noted that while the exact mechanism remains unclear, similar reactions have been observed with other anti-VEGF medications like brolucizumab (Beovu).
Clinical Perspective and Risk Assessment
Despite these concerning findings, experts emphasize that faricimab's overall safety profile remains comparable to other market alternatives. The reported inflammatory complications occur in approximately 0.2% to 0.6% of treated patients.
Healthcare providers are advised to:
- Carefully monitor patients for any signs of inflammation following treatment
- Consider alternative treatments for patients who develop inflammatory reactions
- Discuss potential risks and worst-case scenarios with patients before initiating therapy
- Maintain vigilance in post-treatment follow-up
The findings underscore the importance of careful patient monitoring and informed decision-making in the management of retinal disorders, particularly when considering retreatment after initial adverse reactions.
