The safety evaluation of ocular long-acting delivery (LAD) technologies is a nascent field. Here, we detail the challenges in assessing the safety of novel LAD technologies, and well as the most common types of toxicity encountered during early toxicity testing. A detailed understanding of the route of administration, pharmacology, and functionality and/or pharmacokinetics (PK) of the LAD, along with all of its component parts, including the active pharmaceutical ingredient and excipients, is crucial for the successful development of next-generation long-acting ocular therapeutics.
Copyright © 2019 Elsevier Ltd. All rights reserved.