Retina (Philadelphia, Pa.)
via Europe PMC
REAL-WORLD RETINAL VASCULITIS EVENTS REPORTED WITH FDA-APPROVED INTRAVITREAL ANTI-VEGF AND COMPLEMENT INHIBITOR AGENTS: An Analysis of FAERS Data.
Chhablani J, Nayaka A, Sadeghi E, B G.
AI summary — for doctors, generated from the abstract only
FAERS reports of retinal vasculitis occurred across intravitreal anti-VEGF and complement inhibitors, with brolucizumab most often reported, but the data cannot show risk.
What was studied
Retrospective analysis of FDA FAERS reports (2020-2025, plus 2010-2019 for aflibercept and ranibizumab) of retinal vasculitis events linked to a single intravitreal agent.
Key findings
- 554 retinal vasculitis events identified in 2020-2025: 485 (87.5%) anti-VEGF, 69 (12.5%) complement inhibitors
- Brolucizumab 56.1%, faricimab 16.4%, pegcetacoplan 11.9%, aflibercept 2 mg 8.7%, aflibercept 8 mg 4.2%, ranibizumab 2.2%, avacincaptad pegol 0.5%
- One aflibercept biosimilar event and none for ranibizumab biosimilars
Clinical relevance
Retinal vasculitis is a sight-threatening complication that can occur with any intravitreal agent, so vigilance and reporting matter.
Who should care
Limitations
Spontaneous reports lack denominators, so incidence, causality and comparative risk cannot be determined, and reporting is biased by drug age and publicity.
Counsel patients on symptoms of intraocular inflammation after injections and report suspected cases.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Purpose
To analyze real-world Food and Drug Administration Adverse Event Reporting System (FAERS) data for retinal vasculitis associated with approved intravitreal (IVT) anti-VEGF agents and complement inhibitors in the United States.
Methods
This retrospective study used the publicly available FAERS database to identify serious adverse events related to IVT anti-VEGF and complement inhibitor agents reported between January 2020 and December 2025. Reports for brolucizumab, faricimab, aflibercept, ranibizumab, pegcetacoplan, and avacincaptad pegol were analyzed, with data for aflibercept and ranibizumab also reviewed from 2010 to 2019. Events were filtered to include only those linked exclusively to a single agent. Retinal vasculitis adverse events (RVAEs) were identified using broad search terms related to vasculitis, while vascular occlusions without inflammation were excluded.
Results
FAERS data from January 2010 to December 2025 showed reported RVAEs across all included IVT therapies, with increased reporting after 2019. From January 2020 to December 2025, 554 RVAEs were identified among anti-VEGF reference products and complement inhibitors. Anti-VEGF reference products accounted for 485 reports (87.5%), and complement inhibitors accounted for 69 (12.5%). Brolucizumab accounted for the largest proportion (56.1%; 311/554), followed by faricimab (16.4%; 91/554), pegcetacoplan (11.9%; 66/554), aflibercept 2 mg (8.7%; 48/554), aflibercept 8 mg (4.2%; 23/554), ranibizumab (2.2%; 12/554), and avacincaptad pegol (0.5%; 3/554). Separate biosimilar analysis identified one aflibercept biosimilar RVAE and no ranibizumab biosimilar RVAEs during this updated study period overall.
Conclusions
FAERS reporting identified RVAEs across included IVT therapies, but cannot establish incidence, causality, or comparative risk, underscoring the need for vigilant reporting and ongoing post-marketing safety surveillance.
DOI
10.1097/iae.0000000000004980
PMID
42627260
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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