The National Eye Institute (NEI), a component of the U.S. Department of Health and Human Services through the National Institutes of Health (NIH), has released a funding opportunity titled "NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk." This program, under the U44 activity code, targets U.S.-based small business concerns (SBCs) proposing early-stage clinical trials with a greater than minimal risk profile. It supports commercialization-focused studies aimed at screening, diagnosing, preventing, or treating vision-related disorders.
This cooperative agreement is designed for Phase II or Phase IIB clinical trials and is appropriate for projects that build on previously funded research, including preclinical or planning studies. Applicants without a prior qualifying award must apply under Direct-to-Phase II. Trials funded under this mechanism must be human-subject studies classified as greater than minimal risk per federal definitions. The NEI will engage substantially with awardees, from project plan negotiations through milestone-based oversight. A Data and Safety Monitoring Committee (DSMC) is required, and all activities must be conducted within the U.S. or its territories.
Allowable costs include personnel training, subject recruitment, investigational product procurement, laboratory analysis, data quality management, site monitoring, and regulatory submissions. Studies must be trial-ready at the time of application. Where applicable, FDA documentation must confirm an IND or IDE status—or provide justification for exemption or non-requirement. This ensures all regulatory preconditions are met before funding is awarded. Applications not aligned with NEI's mission, not evaluating interventions, lacking commercialization potential, or exceeding a three-year project period will be considered non-responsive.
Applications must contain a comprehensive clinical protocol, milestone plan, long-term patient care plan (especially for implanted devices), and data management strategy. The commercialization plan must outline market readiness and include a project management strategy, regulatory path, and fundraising plans. The full proposal must follow NIH SBIR submission rules and be submitted via NIH ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. The program requires adherence to performance benchmarks for transition rates and commercialization success, especially for firms with substantial prior SBIR/STTR funding.
The funding opportunity opened on December 1, 2023. Applications are accepted through specific deadlines aligned with NIH cycles, with the next due date being January 24, 2025. Recurring dates through 2026 are available, and applicants are encouraged to apply early to allow time for system error correction. Letters of intent are requested by May 27, 2026, for the final listed cycle. Applicants are strongly encouraged to contact NEI staff at least 12 weeks before submission to confirm project alignment and discuss oversight requirements. The funding ceiling is $1,000,000 per year and $2,000,000 total for a maximum three-year project period.
