1. Jun 30, 2020

Most ophthalmic drug approvals over last 20 years were reformulations

Similar to the rest of the industry, novel ophthalmic pharmaceutical development declined over the past 2 decades, with the majority of approvals coming in the form of reformulations of prior pharmaceuticals, according to a study published in Ophthalmic Epidemiology. However, new legislation has the potential to increase novel therapeutic development.

In this observational study, all original drug approvals for ocular use, including new molecular entities, biologic license applications, reformulations, combinations, and new indication approvals, from January 2000 to December 31, were analyzed.

Researchers identified 99 ophthalmic agents approved during the study period, with new molecular entities and biologics accounting for 22% of all drug approvals.


Gu D, Janetos TM. Ophthalmic drug discovery in the United States over the past two decades [published online ahead of print, 2020 Jun 28]. Ophthalmic Epidemiol. 2020;1-6. doi:10.1080/09286586.2020.1786591