Safety Evaluation of Ocular Drugs

Twenty-three drugs for ophthalmic use have been approved by the U.S. Food and Drug Administration (FDA) since 2001 (Table 29.1). Of these: Approximately 75% are small molecules. 50% are new medical entities (including biologics). 40% are for chronic conditions. Topical ocular (eye drops) is the most common administration route, followed by intravitreal (IVT) injection. Systemic (eg, oral for Valcyte) or other administration routes (eg, intranasal for Astepro) can also be used for treating ocular conditions but are less common. This chapter describes current approaches to characterize ocular safety of new therapeutic options.