Predictive value of the efficacy of glaucoma medications in regulatory trials: Phase I–III to post-marketing studies.

PurposeTo determine the predictive value of early Phase trials (I–II) for the ocular hypotensive efficacy observed in Phases III and IV.DesignA review of published literature.MethodsThis study evaluated 12 medicines in 65 articles in the literature with at least two phases available.ResultsFor medicines with Phase I results available (n=3), the average reduction in intraocular pressure (IOP) from untreated baseline was 16%, 26% for Phase II, 26% for Phase III, and 24% for Phase IV. For medicines with Phase II results available (n=6), the average reduction in IOP was 23%, 24% for Phase III, and 23% for Phase IV. For medicines with Phase III results available (n=11), the average reduction in IOP was 25% and 24% for Phase IV.ConclusionThis study indicates that early phase trials usually approximated the results of later regulatory studies and post-commercialization trials.Eye (2008) 22, 985–988; doi:10.1038/sj.eye.6702913; published online 22 June 2007 [ABSTRACT FROM AUTHOR]