Standardized Scoring of Ocular Findings in the Context of Drug and Device Development Programs

Abstract

This chapter presents a comprehensive review of the approaches and methods used to perform clinical ocular scoring of the anterior and posterior segment in laboratory animals in toxicologic and preclinical drug development studies. It represents a distillation and integration of two recent publications from our group with expanded commentary (Eaton et al., J Ocul Pharmacol Ther 33:707–717, 2017; 718–734). The reader is introduced to the indications and features of the most commonly used semi-quantitative scoring systems in laboratory studies, as well as important limitations and considerations for each. The reader is also introduced to the ocular scoring systems employed by the clinical team at Ocular Services On Demand (OSOD), which modify many criteria from previous systems and introduce novel scoring elements to improve the applicability and predictive value of clinical observations made in support of modern preclinical ocular drug and device development programs. Species considerations pertinent to ocular examination and clinical scoring in general toxicology and ocular drug/device development are also discussed.