LAUSR

ABSTRACT Purpose Pharmaceutical development has slowed since the turn of the century and there has been recent legislation passed that aims to accelerate drug approval. Ophthalmic drug discovery has unique challenges that may benefit from these legislative changes. We report original pharmaceutical approvals for ophthalmic indications in order to determine whether ophthalmic drug approvals are similarly decreasing. Methods This observational study extracted all original drug approvals for ocular use from the publicly available Drugs@FDA database from January 1st, 2000 through December 31st, 2019. Drug approvals included new molecular entities, biologic license applications, as well as reformulations, combinations and new indication approvals. Data mined from each approval included: approval date, active ingredient, manufacturer, new drug application classification type, priority or standard review, and orphan drug status. Data were analyzed in four 5-year time periods. Results A total of 99 ophthalmic agents were approved for ocular use during the study period. On average, drug approvals rose by 2.2 approvals per 5-year quartile. Out of these, new molecular entities and biologics constituted 22% of all drug approvals and fell at an average rate of 0.4 approvals per quartile. Conclusion The majority of ophthalmic drug approvals represented reformulations of prior pharmaceuticals. In line with the overall industry, new molecular entities and novel biologics fell on average during the study period. Legislation that aims to ease challenges to drug approval may be beneficial to increase novel therapeutic development but should be weighed against the risks of decreased patient safety or drug efficacy.