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, χ²>4, n≥3), Bonferroni-adjusted p0. 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 (p0). 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.

It is uncertain whether first- (FGAs) and second-generation antipsychotic (SGAs) drugs are associated with development of cataract. We conducted a real-world adverse event (AE) disproportionality analysis of cataracts in individuals exposed to antipsychotics. An observational, population-based pharmacovigilance study. All reports of cataracts submitted to the U.S. Food and Drug Administration involving FGAs and SGAs. We searched the United States Food and Drug Administration Adverse Event Reporting System (FAERS) (2003 Q4-2024 Q1) for cataract reports associated with antipsychotics, analyzing data with OpenVigil 2.1. Reporting odds ratios (RORs), p values (with a Bonferroni-adjusted significance threshold of 0.0019), and Bayesian Confidence Propagation Neural Network information components (IC) were reported. We retrieved 12,345,128 unique AE reports (5.4% females, 34.5% males), including 34,879 cataract reports and 372,107 antipsychotic reports (10,274 FGAs and 361,833 SGAs). Chlorpromazine (ROR: 7.60; 95%; confidence interval [CI] = 3.78%-15.29%; p < 0.0001; [lower limit of the 95% credibility interval for the information component] IC₀₂₅ = 1.23) and quetiapine (ROR1: 64; 95% CI = 1.44%-1.88%; p < 0.0001; IC₀₂₅ = 0.48) showed significantly higher odds of cataract reporting compared to all other drugs. No significantly higher reporting odds of cataracts were found for the 10 FGAs and 14 SGAs studied. However, increased cataract reporting was observed for chlorpromazine in females and for quetiapine in both sexes. This pattern also occurred in both drugs in the 18-44 and 45-64 age groups, with greater magnitude in the younger group CONCLUSIONS: Cataract development was disproportionately reported after the use of certain FGAs and SGAs. Although a cause-and-effect relationship cannot be established, these findings underscore the importance of clinical vigilance and regular ocular monitoring in individuals prescribed antipsychotics.

Neuroimaging has a key role in identifying small-vessel vasculitis from common diseases it mimics, such as multiple sclerosis. Oftentimes, a multitude of these conditions present similarly, and thus diagnosis is difficult. To date, there is no standardized method to differentiate between these diseases. This review identifies and presents existing scoring tools that could serve as a starting point for integrating artificial intelligence/machine learning (AI/ML) into the clinical decision-making process for these rare diseases. A scoping literature review of EMBASE and MEDLINE included 114 articles to evaluate what criteria exist to diagnose small-vessel vasculitis and common mimics. This paper presents the existing criteria of small-vessel vasculitis conditions and mimics them to guide the future integration of AI/ML algorithms to aid in diagnosing these conditions, which present similarly and non-specifically.