NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)

The purpose of this Notice of Funding Opportunity (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.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase will support research that is in the final states of preclinical development with potential for near-term clinical development. Support for a single phased award that does not need the R61 Exploratory phase is available in the companion R33, PAR-23-205.