Improving the drug development process by reducing the impact of adverse events: the case of cataracts considered

Abstract

Cataract was used as a model for the prevalence and economic impact of adverse events during the drug development process. Meta-analysis revealed a reported prevalence of cataract at 12.0% (1.0-43.3%), 3.8% (2.4-12.5%), 1.0% (0.0-8.1%), 1.7% (0.0-34.8%) and 3.8% (2.3-5.7%) of compounds in preclinical, Phase I, II, III and IV clinical trials, respectively. Utilising a human-based in vitro screening assay to predict cataractogenic potential in human could allow better selection of novel compounds at early-stage drug development. This could significantly reduce costs and ultimately increase the probability of a drug obtaining FDA approval for a clinical application.