■Overview and progress of major development pipelines

4. Ultra-compact ophthalmic diagnostic device “SS-OCT” for astronauts

Kubota Pharmaceutical Holdings ＜4596＞ signed a development contract with NASA in 2019 regarding a development project for the ultra-compact ophthalmic diagnostic device “Swept Source-OCT (hereinafter, SS-OCT)” to perform research on eye diseases caused by space flight, and completed the first phase development mission in early 2020. As for the second phase of development, NASA's development budget was cut due to the US government changing government to the Democratic Party in 2021 and the effects of the national budget being diverted to COVID-19 countermeasures due to the effects of the COVID-19 pandemic, and the state of interruption has continued since then.

The purpose of this project is to study the effects of space flight on the eye region based on a research report* showing that approximately 69% of astronauts who have experienced long-term space flight suffer from neuro-ophthalmic syndrome, where there is a risk of vision impairment or blindness. Currently, the commercially available OCT used at the International Space Station (International Space Station, hereafter, ISS) is stationary and operation is complicated, and astronauts were only able to inspect 3 times during their stay at the ISS for several months. The ultra-compact SS-OCT to be developed this time can be measured by the astronauts themselves every day and stored records, and by analyzing the effects of space flight on eye diseases in more detail, it will be useful for disease risk reduction and prevention.

* Eye disease symptoms such as blurred vision, optic disc edema, posterior ocular flatness, and cottony leukoplakia have been reported.

The entire development phase was divided into 3 steps, and the mission of the first phase was to confirm proof of concept (POC) using lasers, which are durable and inexpensive light sources, and to develop a device that measures the shape of the optic disc with high resolution using multiple lasers. The demonstration conducted at NASA in January 2020 received high praise from NASA projects*. Development of the first phase was completed in 2020/2, a development report was submitted to NASA and TRISH in April of the same year, and development contract revenue of 37 million yen was recorded as business income for the fiscal year ending 2020/12.

*The following comments were received from NASA personnel. “Although it is small, it is easy to operate, and data processing is fast. I believe it will be of great use at the ISS to study effects on the eyeball during space flight.” “Not only did it meet the usage requirements for Phase 1, but it was also more complete than expected. It also has a refined appearance, and is light and easy to hold. I'm looking forward to the finish in Phase 2.”

The second phase is a process of determining what kind of image analysis method is used to verify eye diseases caused by space flight using the same device, and in the final third phase, it is a process of proceeding with the development of a device that can actually be used in a space flight environment. Specifically, the development of hardware that has durability against exposure to space radiation and can be operated by astronauts themselves in a zero-gravity environment will be jointly developed with partner companies.

Currently, the project is suspended, but regular meetings are being held with NASA project personnel, and the intention to continue is confirmed. Therefore, it is expected that it will be resumed as soon as a development budget is attached in the future. Since NASA has begun to allocate budgets again, such as the lunar flight project starting to move, we see that there is a good possibility that the project will resume in the future.

(Author: FISCO Visiting Analyst Joe Sato)