NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) | PAR 25 335

Opportunity Information: Apply for PAR 25 335

The NEI Translational Research Program for Therapeutics (PAR-25-335) is a National Institutes of Health grant opportunity designed to move promising vision research out of the laboratory and toward real-world therapies that clinicians can eventually use to treat diseases or disorders of the visual system. The emphasis is on translational, preclinical development work that bridges the gap between discovery science and early clinical testing. Projects are expected to generate the kinds of rigorous data packages needed to justify and support a future submission to the U.S. Food and Drug Administration, specifically an Investigational New Drug (IND) application for drugs/biologics or an Investigational Device Exemption (IDE) for medical devices, with the longer-term aim of enabling subsequent clinical trials (even though clinical trials themselves are not allowed under this particular NOFO).

This program is built for multidisciplinary teams that combine scientific and clinical expertise, reflecting the reality that successful therapeutic translation typically requires coordinated input across domains such as basic biology, pharmacology, bioengineering, manufacturing/CMC planning, regulatory strategy, and clinically relevant outcome considerations. The program supports a wide range of intervention types, including biological therapies, pharmacological agents, medical devices, and combination products. In practical terms, a competitive application would usually center on a clearly defined therapeutic concept and a development plan that produces decision-quality preclinical evidence, such as proof-of-concept efficacy in relevant models, dose and delivery optimization, preliminary safety/toxicology planning, device performance verification/validation concepts where applicable, and other enabling studies that reduce risk before entering the clinic.

A defining feature of the opportunity is its bi-phasic, milestone-driven structure using the R61/R33 mechanism. The R61 phase functions as an early, exploratory yet translation-oriented stage for projects that already have strong preliminary data but are not yet sufficiently advanced for late-stage preclinical development. During R61, teams are generally expected to complete key experiments that de-risk the program and demonstrate feasibility for translational advancement. The R33 phase is intended for projects that have reached the final stages of preclinical development and can credibly position themselves for near-term clinical development. Transition from R61 to R33 is not automatic; it is guided by the achievement of predefined, measurable milestones that are laid out up front and used to track progress and readiness. For groups that do not need the earlier exploratory stage, the NIH notes a companion single-phase R33 funding opportunity (PAR-23-205) that can support advanced projects entering directly into the later preclinical stage.

The NOFO is explicit that this is a "Clinical Trial Not Allowed" funding opportunity, meaning the supported research should not include clinical trial activities. Instead, the program is meant to produce the preclinical and translational foundation that would justify an IND or IDE submission and enable clinical testing later through other funding sources or mechanisms. The overall orientation is toward practical, milestone-based development rather than open-ended basic research, and applicants are expected to map a clear pathway showing how each milestone moves the therapeutic candidate closer to regulatory readiness.

Eligibility is broad and includes many U.S.-based organizational types: state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The announcement also highlights inclusion of institutions serving specific communities, such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions, along with faith-based/community-based organizations and eligible federal agencies. However, foreign organizations are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible, reinforcing that supported work must be conducted within eligible domestic organizational structures.

Administrative details in the listing identify the sponsoring agency as the National Institutes of Health, with the activity in the health category (CFDA 93.867). The funding instrument is a grant under the discretionary category. The opportunity was created on 2025-01-07, and the original closing date is 2025-03-16. The listing does not provide an award ceiling or expected number of awards in the provided text, so applicants would need to consult the full NOFO for budget limits, project period expectations, and any institute-specific constraints.

Overall, this opportunity is best suited for teams with a well-justified therapeutic candidate for an eye or visual system indication who can articulate a practical preclinical development plan, define concrete go/no-go milestones, and demonstrate that the proposed studies will materially advance the program toward an IND or IDE submission and eventual clinical evaluation, without actually conducting the clinical trial work under this award.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867.
• This funding opportunity was created on 2025-01-07.
• Applicants must submit their applications by 2025-03-16. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 335

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