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Ocular Adverse Events Associated with Antibody-Drug Conjugates in Human Clinical Trials
Joshua Seth Eaton1, Paul E Miller1,2, Mark J Mannis3
11 Ocular Services On Demand (OSOD), LLC , Madison, Wisconsin.
Abstract:
This article reviews ocular adverse events (AEs) reported in association with administration of antibody-drug conjugates (ADCs) in human clinical trials. References reporting ocular toxicity or AEs associated with ADCs were collected using online publication searches. Articles, abstracts, or citations were included if they cited ocular toxicities or vision-impairing AEs with a confirmed or suspected association with ADC administration. Twenty-two references were found citing ocular or vision-impairing AEs in association with ADC administration. All references reported use of ADCs in human clinical trials for treatment of various malignancies. The molecular target and cytotoxic agent varied depending on the ADC used. Ocular AEs affected a diversity of ocular tissues. The most commonly reported AEs involved the ocular surface and included blurred vision, dry eye, and corneal abnormalities (including microcystic corneal disease). Most ocular AEs were not severe (≤ grade 2) or dose limiting. Clinical outcomes were not consistently reported, but when specified, most AEs improved or resolved with cessation of treatment or with ameliorative therapy. A diverse range of ocular AEs are reported in association with administration of ADCs for the treatment of cancer. The toxicologic mechanism(s) and pathogenesis of such events are not well understood, but most are mild in severity and reversible. Drug development and medical professionals should be aware of the clinical features of these events to facilitate early recognition and intervention in the assessment of preclinical development programs and in human clinical trials.
Insights
Antibody-drug conjugates (ADCs) can cause ocular adverse events (AEs), primarily affecting the ocular surface with symptoms like blurred vision. Most AEs are mild and reversible, aiding early recognition in cancer treatment.
Area of Science:
- Oncology
- Ophthalmology
- Pharmacology
Background:
- Antibody-drug conjugates (ADCs) are increasingly used in cancer therapy.
- Ocular adverse events (AEs) are potential side effects of ADC administration.
- Understanding these AEs is crucial for patient safety and treatment management.
Purpose of the Study:
- To review and summarize ocular adverse events associated with ADCs in human clinical trials.
- To identify common ocular toxicities and their characteristics.
- To inform clinicians and researchers about potential ocular side effects of ADCs.
Main Methods:
- Systematic review of online publications and databases.
- Inclusion of references reporting ocular toxicity or vision-impairing AEs linked to ADCs.
- Analysis of 22 relevant references detailing ADC-associated ocular events.
Main Results:
- Ocular AEs were reported in association with ADCs used for various malignancies.
- Common AEs included blurred vision, dry eye, and corneal abnormalities (e.g., microcystic corneal disease).
- Most ocular AEs were mild (≤ grade 2), not dose-limiting, and often improved with treatment cessation or supportive care.
Conclusions:
- ADCs can cause a range of ocular AEs, predominantly affecting the ocular surface.
- The exact mechanisms of these AEs are not fully understood, but they are generally mild and reversible.
- Awareness of these ocular AEs is essential for early detection and intervention in clinical practice and drug development.
