Retinal Vasculitis Signals Emerge Across Intravitreal Anti-VEGF and Complement Inhibitor Therapies
核心洞察
A FAERS analysis of 554 serious adverse events (2020–2025) found brolucizumab accounted for the highest proportion of retinal vasculitis (搜索) reports at 56.1% (311 reports).
When events were attributed exclusively to each drug, brolucizumab (18.2%) and pegcetacoplan (17.9%) showed the highest proportions, followed by faricimab (5.2%) and aflibercept 8mg (4.1%).
The authors caution that FAERS spontaneous-reporting data cannot establish incidence or comparative risk, lacking denominator data and adjudicated causality.
A real-world analysis of the FDA Adverse Event Reporting System (FAERS) has identified adverse retinal vasculitis (搜索) events associated with FDA-approved intravitreal anti-VEGF and complement inhibitor agents, with brolucizumab accounting for the largest share of reports. The findings, published in Retina, examined spontaneous reports from January 2020 through December 2025 and reinforce the importance of recognizing and reporting retinal vasculitis in clinical practice.
Researchers analyzed FAERS reports for brolucizumab, faricimab, aflibercept, ranibizumab, pegcetacoplan, and avacincaptad pegol. Aflibercept and ranibizumab reports from 2010 through 2019 were also reviewed. The analysis was limited to serious adverse events in which the drug was identified as the sole suspected agent, excluding vascular occlusions without intraocular inflammation.
Report Distribution Across Agents
The authors identified 554 adverse events during the 2020–2025 period. Anti-VEGF reference products comprised 87.5% of reports, while complement inhibitors accounted for 12.5%. Brolucizumab made up the highest proportion at 56.1%, representing 311 reports.
When vasculitis events were attributed exclusively to each individual drug, brolucizumab remained the highest proportion at 18.2%, followed by pegcetacoplan at 17.9%. Faricimab accounted for 5.2%, aflibercept 8mg for 4.1%, avacincaptad pegol for 3.5%, aflibercept 2mg for 0.8%, and ranibizumab for 0.7%.
The authors also noted that biosimilar drug analysis identified one aflibercept biosimilar retinal vasculitis (搜索) event and none from ranibizumab biosimilars.
Interpreting Spontaneous-Reporting Data
The authors cautioned that these figures do not represent incidence or comparative risk. FAERS relies on "spontaneous-reporting data," as explained in the paper, and "does not provide denominator data, treated patients, number of injections administered, verified exposure time, or adjudicated causality." The reports used in the study may also have been incomplete, duplicated, or unverified.
Despite these limitations, the findings underscore the necessity of recognizing and reporting retinal vasculitis (搜索) across intravitreal therapies, particularly as newer agents and higher-dose formulations continue to enter clinical practice.