The NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) aims to support the rapid and efficient translation of innovative laboratory research findings into therapeutics for visual system diseases or disorders. Administered by the National Eye Institute under the National Institutes of Health, this funding opportunity seeks to bridge the gap between preclinical research and clinical applications. The program focuses on generating preclinical data necessary for submitting Investigational New Drug or Investigational Device Exception applications to the U.S. Food and Drug Administration and preparing for clinical trials. Multidisciplinary teams of scientists and clinicians are encouraged to address diseases such as retinal diseases, corneal diseases, cataracts, glaucoma, optic neuropathies, strabismus, amblyopia, and conditions related to low vision and blindness rehabilitation.

The funding mechanism uses a two-phased, milestone-driven approach. The R61 phase, lasting up to two years, supports research with significant preliminary data but not yet ready for clinical translation. Activities in this phase may include refining device designs, conducting animal testing, optimizing lead therapeutic agents, and engaging in pre-submission regulatory activities with the FDA. The R33 phase, lasting up to three years, focuses on advancing single therapeutic candidates through IND or IDE-enabling studies, preparing regulatory documents for FDA submission, and designing future clinical trials. Both phases require clearly defined milestones that are specific, measurable, achievable, relevant, and time-bound.

Eligible applicants include higher education institutions, nonprofit organizations, for-profit organizations, local and state governments, Native American tribal organizations, and other entities as specified in the funding announcement. Non-domestic entities are not eligible to apply, but foreign components of U.S. organizations are allowed. Applicants must demonstrate expertise in regulatory approval processes, include a multidisciplinary team, and propose a clear and feasible pathway toward clinical translation.

Application budgets should not exceed $500,000 per year in direct costs during the R61 phase and $1,000,000 per year in direct costs during the R33 phase. The maximum combined project period is five years. Applicants must address both phases in their proposals and are encouraged to consult NEI staff at least twelve weeks before submission. Pre-submission feedback from the FDA is a required milestone for the R61 phase.

Key application components include a Target Product Profile, a Gantt chart outlining milestones, and an Intellectual Property Strategy document. Applications must also outline a robust regulatory strategy, plans for data management and sharing, and a clear timeline for milestone achievement. The submission deadline for applications is February 16, 2025, with scientific merit reviews scheduled for June 2025 and final funding decisions expected by December 2025.

Applications will be evaluated based on their significance, innovation, rigor, feasibility, milestones, and the expertise of the research team. The evaluation will consider the clarity of the proposed milestones, the strength of the regulatory strategy, and the likelihood of transitioning the therapeutic candidate to clinical development. Successful applicants must comply with NIH policies on data management, intellectual property, and other administrative requirements. Further details, including submission instructions and contact information for program officials, are available in the full funding opportunity announcement.