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Ocular adverse events associated with antibody-drug conjugates: a comprehensive pharmacovigilance analysis
Heng Chen1, Gefei He1, Juanjuan Huang1
1Department of Pharmacy, The First Hospital of Changsha, Changsha, Hunan, China.
Introduction:
Antibody-drug conjugates (ADCs) are increasingly utilized in patients with solid tumors and hematologic malignancies. However, the adverse ocular toxicity induced by ADCs has not been comprehensively evaluated in real-world clinical settings.
Methods:
Data from April 2019 to March 2024 based on the FDA Adverse Event Reporting System (FAERS) were extracted and analyzed. Disproportionality analysis was used to evaluate the association between ADCs and ocular adverse events (AEs). The median time to onset (TTO) of various ADCs was compared.
Results:
A comprehensive analysis identified 2,686 ocular AEs associated with ADCs. Among these, Tisotumab vedotin had the most positive signals at the preferred terms (PTs) level, followed by trastuzumab emtansine and enfortumab vedotin. In contrast, gemtuzumab ozogamicin demonstrated minimal ocular toxicity signals. Cluster analysis revealed that ADC-related ocular toxicities predominantly manifested as corneal disorders or ocular neuromuscular disorders. The median onset of ocular toxicity varied considerably, with enfortumab vedotin showing the earliest median onset at 12.5 days.
Conclusions:
Our study demonstrates the association between ADCs and ocular AEs based on real-world data, providing valuable guidance for clinicians when prescribing ADCs. And we found some important safety signals that have not been mentioned in the label or previous studies.
Insights
This study analyzed real-world data on antibody-drug conjugates (ADCs) and found significant ocular adverse events (AEs), with specific ADCs showing higher toxicity signals and varying onset times. These findings offer crucial guidance for clinicians managing ADC therapy.
Area of Science:
- Oncology
- Pharmacovigilance
- Ophthalmology
Background:
- Antibody-drug conjugates (ADCs) are vital in treating solid tumors and hematologic malignancies.
- Comprehensive real-world evaluation of ADC-induced ocular toxicity is lacking.
Purpose of the Study:
- To evaluate the real-world association between ADCs and ocular adverse events (AEs).
- To identify specific ADCs with significant ocular toxicity signals and compare their onset times.
Main Methods:
- Analysis of FDA Adverse Event Reporting System (FAERS) data from April 2019 to March 2024.
- Disproportionality analysis to assess ADC-ocular AE association.
- Comparison of median time to onset (TTO) for various ADCs.
Main Results:
- Identified 2,686 ocular AEs linked to ADCs.
- Tisotumab vedotin, trastuzumab emtansine, and enfortumab vedotin showed the most positive ocular toxicity signals.
- Ocular toxicities primarily involved corneal or neuromuscular disorders, with enfortumab vedotin having the earliest median onset (12.5 days).
Conclusions:
- Real-world data confirm the association between ADCs and ocular AEs.
- Identified novel safety signals for specific ADCs, aiding clinical decision-making.
- Findings provide essential guidance for clinicians prescribing ADCs and managing potential ocular toxicities.
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