NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) - 073

The National Eye Institute, operating under the U.S. Department of Health and Human Services, is offering the NEI Translational Research Program for Therapeutics through a bi-phasic grant mechanism. This funding opportunity, announced under the identifier PAR-26-073, is intended to foster the translation of laboratory research into clinical therapeutics for diseases and disorders of the visual system. It emphasizes bridging the gap between basic research findings and the development of biological, pharmaceutical, medical device, or combination therapies for clinical use. The grant is structured as an R61/R33 mechanism and does not allow clinical trials. The R61 phase, which can last up to two years, supports projects that already have significant preliminary data but are not yet at the stage of clinical translation. This phase is designed to advance early-stage product development and requires applicants to propose milestones that are specific, measurable, achievable, relevant, and time-bound. These milestones must clearly demonstrate progress toward later-stage therapeutic development. The inclusion of contingency plans to address potential delays is strongly encouraged. Applicants with research programs already beyond this stage may bypass the R61 and apply directly to the R33 phase if they can demonstrate evidence of a pre-IND or pre-IDE meeting with the FDA. The R33 phase may span up to three years and is focused on preclinical development activities necessary for regulatory submission. The scope of this phase includes IND or IDE enabling studies, preparation of FDA submission packages, and the design of clinical trial protocols. Applicants must demonstrate the capability to either submit or obtain FDA approval for an IND/IDE application during the award period, or else transition their therapeutic candidate into clinical practice. The nature of work funded under this phase will vary depending on the therapeutic modality, but all projects must have well-defined and achievable product development goals. Applications to this program must clearly articulate milestones for both phases, demonstrating feasibility and providing criteria for success. Milestones are treated as critical benchmarks for evaluating progress and determining whether projects advance to the next stage of support. Each milestone should mark the completion of a significant portion of the research plan. The NEI emphasizes that milestones serve as both a management and accountability tool for applicants and funders. Eligibility for this opportunity is broad, covering state, county, and city governments; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations including small businesses; special district governments; housing authorities; independent school districts; Native American tribal governments and organizations; and faith-based or community-based organizations. This wide eligibility reflects the goal of encouraging participation across academic, government, nonprofit, and industry partners. Regional organizations and public housing authorities are also specifically listed as eligible applicants. The opportunity is currently in a forecast stage, with applications expected to open on November 3, 2025, and close on February 16, 2026. Awards are anticipated to be issued by December 1, 2026, with projects beginning on the same date. Approximately five awards are expected to be distributed, although the total program funding and award ceilings have not been published at this time. Cost sharing or matching is not required for applicants. The assistance listing for this grant is 93.867, Vision Research. Interested applicants can contact Tony Gover, Ph.D., at the National Institutes of Health for further details. He can be reached via phone at 301-529-7320 or by email at tony.gover@nih.gov. No additional application instructions or required forms beyond the general NIH guidelines are noted at this stage, though applicants should expect to follow NIH submission standards and processes through Grants.gov.