Ophthalmic Assessment Requirements For Drugs With Ocular Toxicity Risk

When a drug in development shows a possible eye-related safety signal, or the FDA asks for ocular safety data, study teams outside ophthalmology can face a steep learning curve. Sites built for infusions or lung function testing may suddenly need specialized eye exams. There is no one-size-fits-all schedule, but FDA labels for three antibody-drug conjugates with known eye toxicity show what monitoring can look like: exams at baseline and tied to dosing, performed by eye care professionals, with results that can decide whether a dose is given, held, or reduced.

This guide explains how to match each exam to where in the eye the risk sits, why non-ophthalmic sites struggle to deliver these assessments, and five practical steps for building a monitoring plan sites can actually carry out. Build eye safety monitoring into your protocol before the first dose, so a late requirement doesn’t stall enrollment or throw off your dosing schedule.