Nonclinical Regulatory Aspects for Ophthalmic Drugs
Andrea B. Weir, Susan D. Wilson · Molecular and integrative toxicology · 2012
Development of ocular products and novel delivery systems for the treatment of retinal and other ocular conditions is an active area of drug development. In the United States of America (USA), regulatory expectations for the nonclinical studies needed to support clinical development of ocular products are not yet defined in a guidance document. Similar to other drugs, however, therapeutics directly administered to the eye undergo safety evaluation in nonclinical studies to support clinical trials and, ultimately, drug approval. The nonclinical testing strategy for an ocular drug (i.e., drugs applied directly onto or into the eye) will be impacted by a number of indication-specific factors including route of administration; extent of systemic exposure, which may be relatively limited especially for some sustained-release delivery systems; and whether the drug is a new molecular entity (NME) or an already approved drug. The nonclinical programs to support development and approval of ocular drugs, therefore, will variably differ from nonclinical programs for drugs administered orally or via other systemic routes. A regulatory perspective on the types of nonclinical safety and toxicity studies appropriate for ocular therapeutics is outlined in this chapter. These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.