The purpose of this NOFO is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians must focus on generating preclinical data that will lead to the development of biological, pharmacological, medical device and/or combination product interventions. The ultimate goal of this program is to make new technological, biological and pharmacological resources available to clinicians and their patients.The steps towards this goal should be clearly delineated in a series of milestones that support the development of a therapeutic or device that will lead to an Investigational New Drug (IND) or Investigational Device Exception (IDE) application to the U.S. Food and Drug Administration (FDA) and/or testing in a clinical trial.The R33 is to focus on advancing a single therapeutic candidate through IND/IDE -enabling studies, filing an IND package with the FDA, and designing future clinical trials. Applicants pursuing early stage applied research should consider the companion (R61/R33) NOFO PA-23-XXX.
