Ocular Laboratory for Analysis of Biomarkers (OCULAB)

The OCULAB program, managed by the Advanced Research Projects Agency for Health (ARPA-H), seeks innovative solutions for non-invasive, continuous monitoring and treatment of ocular and systemic conditions, including dry eye disease (DED). The program focuses on creating a platform that integrates a tear biomarker-monitoring biosensor, housed in a punctal plug or similar device, with an AI-driven closed-loop therapeutic delivery system. This solution aims to improve diagnostics, therapeutic precision, and patient compliance, ultimately addressing treatment gaps in DED and potentially other conditions. The project anticipates advancing technologies to enable continuous monitoring of biomarkers in tears, similar to but more advanced than existing health wearables. OCULAB’s technical requirements are split into two main areas: the continuous monitoring nanosensor (TA1) and the closed-loop therapeutic delivery device (TA2). For TA1, developers must create a nanoscale biosensor capable of detecting at least two disease-related biomarkers, including tear osmolarity, and integrating with external wearable devices. This biosensor must be able to securely upload data to a cloud platform where an algorithm can interpret deviations related to disease states versus situational factors (e.g., exercise, sleep). TA2 focuses on developing a therapeutic delivery system that responds to sensor data and administers micro-doses of a DED-modifying drug. This device should reside within the orbital or periocular area, release doses in real-time based on biomarker levels, and maintain a therapeutic response time of five minutes or less. The program has three project phases with detailed milestones. Phase I (18 months) involves initial development of the sensor and therapeutic device prototypes with baseline biomarker detection and data storage capabilities. Phase II (12 months) expands testing to large animal models to validate functionality, longevity, and sensor efficacy, while Phase III (18 months) will involve human clinical trials and final adjustments to device functionality and safety. Each phase includes predefined metrics such as minimum device sensitivity (85-98%) and longevity goals (1-6 months post-insertion), among others, to ensure feasibility and scalability. Participation in OCULAB is open to diverse team configurations, including private companies, academic institutions, and non-profits. Foreign organizations may participate with specific compliance requirements, although U.S.-based work is prioritized. Federal agencies are not eligible to apply directly. Proposers are required to submit an initial solution summary by January 27, 2025, with full proposals due April 14, 2025, following ARPA-H feedback on the initial submissions. Evaluation criteria will prioritize scientific merit, potential health impact, relevance to the ARPA-H mission, and cost-value analysis. Compliance with federal policies on human subjects and animal research is mandatory, and applicants are encouraged to integrate health equity considerations to improve accessibility of the developed technologies. Monthly and end-of-phase reports are required to monitor project progress, with additional data submission to ARPA-H upon request. The final deliverables must include a therapeutic device prototype, a validated algorithm, and a commercialization plan to support clinical development post-OCULAB.