Description:
AbstractEye drops constitute majority of ophthalmic drug products, with solutions, suspensions, ointments, and emulsions being the top formulations. While solutions are considered simple formulations, with biowaiver granted for qualitatively and quantitatively similar generic formulations, others are complex formulations, whose generic products are difficult to develop and translate. In particular, manufacturing processes as well as the grades of inactive ingredients used can affect drug product attributes and bioavailability. Thus, bioequivalence of complex generics is less certain. The US FDA issued some draft guidance documents to ease approval of complex generic drug products. One purpose of this presentation is to discuss the difficulties in clinical translation of complex generic eye drop products. In recent years, there has been significant effort in developing eye drops for back of the eye drug delivery, using either pure drug formulations or carrier‐drug composite formulations (e.g., polymeric nanoparticles), with little or no success to date. The second purpose of this presentation is to discuss translational gaps in advancing eye drops for back of the eye drug delivery and to further discuss the difficulties in manufacturing and stabilizing composite nanoparticle formulations for eye drop applications.