How Much Nonclinical Safety Data Are Required for a Clinical Study in Ophthalmology?

Abstract

Abstract

Planning the nonclinical development program for an ophthalmic product requires first an understanding of how the drug will be used in the clinic–topical, injected, relatively short duration of testing, chronic testing, and what is already known about the drug. In some cases, when the drug is being repurposed or reformulated to allow for the same or different route of ocular administration, the requirements will be very different than for a first-in-class, novel drug. In general, ICH guidances have relatively little direction with respect to ophthalmology. Sponsors are encouraged to make use of meetings with the FDA, particularly for unusual situations, given this lack of specific ICH direction. In this article we describe the range of nonclinical studies required in our experience–pharmacology, pharmacokinetics and toxicology, with attention to the stage of clinical development and duration of treatment. As well, we discuss the coordination of effort with pharmaceutics researchers on drug substance and drug product.