Nonclinical study requirements for ophthalmic drugs and devices in the United States

The eye is a unique organ embryologically, immunologically, physiologically and consequently exhibits unique toxicological responses. Toxic responses in the eye may result from topical ocular administration of drugs, intraocular administration or implantation of drugs or devices or may be the result of target organ toxicity following systemic administration of a drug. The primary responsibility of the toxicologist is to establish the safety/toxicity profile for a drug or device under development and thus provide an appropriate risk analysis of the drug/device for human use. For the ophthalmic toxicologist this safety profile must include the appropriate toxicological evaluations to place in perspective the intended use of the drug or device, its effect on the relevant ocular tissues, its potential for adverse systemic effects, if warranted, and the potential risk to the patient in the clincal setting.