Comparative Analysis of Ocular Adverse Events between Aflibercept 8 mg and Faricimab
Bibliographic record
Abstract
To compare the ocular safety of intravitreal aflibercept injections and faricimab using population-based, global postmarketing data in a large pharmacovigilance study. Population-based, retrospective pharmacovigilance study. Patients for whom ocular adverse event (AE) reports were submitted to the U.S. FDA Adverse Event Reporting System (FAERS) between January 2004-June 2025, and for whom intravitreal aflibercept injections (2 mg or 8 mg, where dose was recorded) or faricimab were listed as the primary suspect drug, were included. After deduplication, disproportionality was assessed using reporting odds ratios (RORs, 95%CI). Safety signals were considered statistically significant if they met Evans’ criteria (ROR>2, χ 2 >4, n≥3), Bonferroni-adjusted p<0.0003, and Bayesian threshold IC 025 >0. Disproportionality signals for ocular adverse events associated with intravitreal aflibercept 2 mg, aflibercept 8 mg, and faricimab, using aflibercept 2 mg as the reference comparator given its longer market availability and well-established safety profile. Among 13,809,873 FAERS reports, 30,761 involved intravitreal aflibercept 2 mg (n=21,058), aflibercept 8 mg (n=727), or faricimab (n=8,976). After deduplication, 8,352 reports remained for aflibercept 2 mg, 327 for aflibercept 8 mg, 4,168 for faricimab, and 13,797,026 for other drugs. Most patients were aged 65–85 years; women comprised 48.6% of the 8 mg group, 39.9% of faricimab, and 20.8% of the 2 mg group. Aflibercept 8 mg showed the highest disproportionality for intraocular inflammation and infection-related events, including anterior chamber flare (ROR=1410.5), vitritis (853.3), retinal vasculitis (352.2), and infectious (1208.3) and sterile endophthalmitis (352.0), as well as blindness (71.1) and reduced visual acuity (74.6). Faricimab had the highest RORs for injection-related inflammatory and hemorrhagic events—hypopyon (112.8), retinal pigment epithelial tear (193.9), choroidal hemorrhage (142.3), and pseudoendophthalmitis (309.9)—while aflibercept 2 mg was more often associated with structural complications, including increased intraocular pressure (187.8), posterior capsule rupture (80.1), vitreous hemorrhage (76.9), and retinal detachment (20.8). All signals met Bonferroni-adjusted significance (p<0.0001) and Bayesian criteria (IC 025 >0). Aflibercept 8 mg showed strong signals for intraocular inflammation, vasculitis, and endophthalmitis, aflibercept 2 mg was linked to structural complications, and faricimab had the highest disproportionality for select immuno-vascular events. These findings delineate agent- and dose-specific safety profiles within a unified comparative framework and reinforce the critical need for ongoing postmarketing surveillance.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".