OCULAB Frequently Asked Questions

No, the diagnostic and therapeutic devices must be self-powered. We do not want any external or visible components to OCULAB, nor do we want there to be any need for patient involvement in its use or maintenance.

The device must fit within the canaliculus. Performers should study the architecture of the canaliculus in order to develop a device that can be inserted non-invasively and not distort the natural anatomy. 

Contact lens technologies (as well as other technologies which would involve patient involvement or handling) are excluded from proposal to the OCULAB program.

Existing technologies that fit within the specified dimensions and meet the goals may be considered but must be justified within the context of the ISO requirements.

The delivery device must reside within the orbital or periorbital region and be placed in either one or both eyes experiencing symptoms. The patient must not be able to see or feel the OCULAB therapeutic device or be concerned about it falling out.

Preclinical studies including animal models validating sensor fouling mechanisms and safety mechanisms are part of the ISO requirements.

Yes, quantification of tear osmolarity is required as outlined in the ISO.

There must be a minimum of 2 biomarkers per disease state. Additional relevant and validated biomarkers may be proposed.

We welcome all innovative treatment options to be utilized in the OCULAB delivery device. The use of existing therapeutics is acceptable, provided they are disease-modifying and not symptomatic treatments and that a case can be made that microdosing via OCULAB would be more therapeutically beneficial compared to eyedrops.

The delivery device must include a pharmaceutical treatment.

MEMS-based technology may be considered based on its functionality.

Yes, using a combination therapy in the delivery device is acceptable, provided they are disease-modifying and not symptomatic treatments.

The final therapeutic device longevity must be demonstrated to remain effective for as close to six months post-implantation as possible, to minimize the frequency of patient visits to the doctor. However, efficacy is of utmost importance, and if duration is less than six months, removal and replacement of the TA2 device may be acceptable.

The physician needs to know the formula to input the parameters. The AI should learn from the physician to provide informed treatment, but the physician has the final authority over the therapeutic parameters.

Yes, two separate teams from the same institution may submit a solution summary and a proposal to the same program (OCULAB).  Proposers who submit a Solution Summary may submit one (1) full proposal as the Prime awardee but may also be a sub-awardee on two (2) additional proposals. At the full proposal stage, ARPA-H will not compensate performers twice for duplication of efforts. If both proposals are approved, a performer can be a sub on a maximum of three (3) proposals as long as their contribution to each effort is novel to each proposal.

Yes, you may budget for work with a CRO.

No, we want you to choose the best people to achieve your goals.

No, you have to go through the OCULAB Teaming page to find potential teammates or collaborators.

We do not have any specific guidance with regards to teaming. We want you to choose the best people to help you achieve your goals.

Yes, the team composition can be modified with proper justification.

Federal entities are not allowed as prime or subawardees, but collaboration with federal partners may be allowed through separate agreements. 

While there is no need for a specific subspecialty, relevant experience and expertise is needed for the Prime PI.

There are no specific requirements regarding tenure, and so a junior faculty member would be acceptable as Prime PI with demonstrated relevant experience and expertise.

Yes, UARCs can may propose to the OCULAB solicitation.

We want to see enough preliminary data to understand your capability of doing what you are proposing, but it would be highly reasonable to make multiple attempts or test multiple theories. 

The program team encourages a “multiple shots on goal” comprehensive experimental approach to account for a variety of possible approaches to the sensor and/or delivery device. If a complete change in the experimental approach is needed, you will be asked to communicate that with the OCULAB team and justify the modifications. 

A broad approach is preferred to encompass as many dry eye disease patients as possible.

The second disease state can be unrelated to dry eye; therefore, multiple animal models are acceptable.

No, the only requirement is that performers use large animals which can accommodate a punctal insert (e.g., rabbits, pigs, etc).

Yes.

No, we don’t want the patient to be involved at all. Everything from tear sampling to therapeutic delivery should be automated and take place in the ocular/periocular region.

We will entertain all approaches that are proposed, as long as they fit within the TA guidelines and can be used to satisfy the metrics proposed in the OCULAB ISO.

No, OCULAB solutions should be more generalized to address a majority of all dry eye disease patients and not a specific subset.

No, we ask that you create a sensor for the systemic disease of your choice. It does not have to correlate with dry eye disease.

The delivery device must fit comfortably in the periocular region and not be seen or felt by the patient.

Yes, no cutting should be involved in the insertion of the OCULAB device.

When applicable, relevant validation methods should be considered.

Yes, the ISO specifies that we will require a failsafe in place in the event that connectivity is lost.

The systemic disease may be unrelated to dry eye.

OCULAB is only meant to be a proof-of-concept device at the conclusion of the program. The OCULAB team will provide FDA consulting services as needed.

We want you to work hard to meet them. We aim to set our goals high, with the understanding that advancements in science cannot be made without failures along the way. 

OCULAB has three Phases, and not all offerors are guaranteed to continue to subsequent phases. However, the metrics are not necessarily rigid Go/No-Go criteria, and instead are used to help make decisions about whether sufficient progress has been made. In other words, the answer to these questions will depend on the state of the technical program and how much progress has been made.

Yes, absolutely, provided you are meeting/exceeding all technical metrics and guidelines.

We are open to other approaches that would define success in each TA as long as they are a logical fit to satisfy the TA.

Ideally, proposed biomarkers should be supported by peer-reviewed literature. However, in the scenario that a proposed biomarker is unpublished preclinical or clinical data that supports the relevance and validity of the biomarker may be acceptable.

Proposers are encouraged to propose a realistic, justifiable, comprehensive, and reasonable budget that aligns with the proposed solution. The proposed budget should align with the technical scope. No budget ceiling has been established. ​

We are not able to provide budgetary details for OCULAB or a target number for your budget.​

ARPA-H discourages strategies such as using only junior staff or proposing only low-risk ideas to cut costs.

Since 1990, Congress has legislatively mandated a limitation on direct salary for individuals under NIH grant and cooperative agreement awards. The Consolidated Appropriations Act, 2024 (Public Law 117-328) restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. This means that the maximum pay for any one person in one year, for any labor category, and any level of effort is $221,900. 

Yes, you may structure your budget to include all necessary components needed for success of your program.