Objective:

To improve consistency in assessing ocular adverse events associated with antibody-drug conjugates (ADCs) and to provide clear guidance for dose modification in oncology trials.

Key Findings:

• Ocular toxicity occurs in up to 90% of patients receiving certain ADCs, with corneal pseudomicrocysts being the most notable, highlighting the need for effective management strategies.
• The new grading scales separate objective signs from subjective symptoms and include explicit drug dose modification guidance, which is crucial for clinical decision-making.
• Implementation of the new grading system in the I-SPY 2 trial did not result in reported irreversible ocular toxicity, suggesting its potential effectiveness in practice.

Interpretation:

While the new grading scales have shown effectiveness in clinical trials, their real-world application remains variable among physicians, with some preferring traditional methods, which may impact patient safety and treatment outcomes.

Limitations:

• Real-world usage of the grading scales is inconsistent, with some ophthalmologists not utilizing them outside of clinical trials, potentially due to lack of familiarity or training.
• Corneal pseudomicrocysts were excluded from grading due to difficulty in visualization and asymptomatic cases, which may lead to underreporting of ocular toxicity.

Conclusion:

The new grading scales provide a structured approach to managing ocular adverse events from ADCs, potentially reducing unnecessary treatment discontinuation, but require further adoption and education in clinical practice.