■Overview and progress of Kubota Pharmaceutical Holdings' main development pipeline ＜4596＞
2. “EyeMo” retinal monitoring device for at-home/remote ophthalmology
(1) Characteristics and competitive situation of “eyeMO”
“EyeMO” * is an at-home/remote ophthalmology medical retinal monitoring device (Patient Based Ophthalmology Suite) for patients with retinal diseases such as wet age-related macular degeneration and diabetic macular edema. It is a system where patients themselves measure and photograph the thickness of the retina at home, the doctor in charge confirms the data via the internet, and diagnoses whether treatment (medication) is necessary.
* Conventionally, it has been expressed as PBOS, but since the product name was decided to be “eyeMo” in 2023/12, it will be expressed as “eyeMo” thereafter. The origin of the name is a combination of eye (eye) and monitoring (observation) Mo.
Conventionally, patients regularly go to the hospital to perform OCT* tests, and treatment (intraocular injections) is performed as needed. With “eyeMO,” since tests can be easily performed at home, there is no need to go to the hospital for tests, and there is an advantage that the risk of worsening symptoms can be reduced by receiving treatment at an appropriate timing. Since there are many patients who cannot go to the hospital regularly due to distance or financial issues and their symptoms worsen, there is a large potential need for devices that can be easily tested at home. On the hospital side, increasing the time spent on treatment rather than testing is a plus in terms of management, and there is a possibility that sales volume will increase compared to the past due to implementation of appropriate medication for pharmaceutical companies, and it is characteristic that it is a system where all parties involved can enjoy advantages.
*OCT (Optical Coherence Tomography): An inspection device that accurately photographs a cross-section of the retina using infrared rays. It is used to diagnose patients with retinal diseases such as glaucoma and age-related macular degeneration.
There are still no companies commercializing at-home OCT, and companies that have already been developed are limited to a few companies such as Notal Vision, Inc. in addition to the company. The company's products are designed with elderly patients in mind, such as larger operation buttons and implementing functions that support operation methods with voice guidance, and they are also characterized by the fact that the test time is shorter and easier to use than competitor Notal Vision products. On the other hand, in terms of functionality, it is kept to the minimum necessary. Notal Vision products are being applied for sales approval in the US, and the company looks like it has been delayed slightly, but it seems that there is an opportunity to bounce back in the future. This is because institutional issues, including risk aspects, remain for patients themselves to perform simple tests at home, and there is also a view that full-scale dissemination will occur after establishing a system design.
(2) Joint development agreement with AUROLAB
The company announced in 2023/12 that it has signed a basic agreement with AUROLAB (India), a medical product manufacturer specializing in the ophthalmology field, for joint development of “eyeMO.” According to the agreement, AUROLAB will exclusively obtain licenses related to product development, manufacturing, and sales in order to commercialize “eyeMo,” which is part of untapped markets in the Middle East, Asia, and Africa, such as India, Pakistan, Afghanistan, Bangladesh, Bhutan, Maldives, Nepal, and Sri Lanka. Detailed contract terms will be discussed in the future, but it seems that royalties corresponding to sales will be received, and it is thought that there will be no impact on short-term business results.
AUROLAB is a group company of Aravind Eye Hospital (hereafter, AECS), which mainly manufactures intraocular lenses, surgical sutures, pharmaceuticals, surgical blades, etc., and is one of the most prestigious eye hospitals in the world. AECS has 14 ophthalmology hospitals, 6 outpatient ophthalmology test sensors, and 108 initial ophthalmology medical facilities in South India, and is said to be the world's top class in terms of number of surgeries per year, and AUROLAB sells medical devices not only to the AECS Group but also to eye hospitals in over 160 countries around the world.
AULOLAB seems to aim not only to support patients with age-related macular degeneration and diabetic macular edema, but also to contribute to early detection of retinal diseases by introducing “eyeMO,” which has been mass-produced and reduced in price, to ophthalmology clinics and public facilities, etc., and I would like to pay attention to future developments.
(3) Vendor agreement signed with IQVIA Services Japan
In 2023/12, it was announced that a vendor agreement for “eyeMO” was signed with IQVIA Services Japan, which intervenes as an organization in charge of coordination management practices, in order to use “eyeMO” in specific clinical research scheduled to be funded by Chugai Pharmaceutical. It is expected that loan revenue from “EyeMo” will be obtained in the future, but the number of loans is not large, and it seems that it is insignificant in terms of money. A feasibility study is scheduled to be conducted around spring 2024 before clinical research begins. In specific clinical research, it is a study for patients with diabetic macular edema to verify whether patients themselves can use “eyeMO” at home, and also evaluate the appropriateness of retinal thickness measurement values and retinal state measurement values to determine the presence or absence of intraretinal/subretinal edema by medical personnel.
Looking at the status of clinical trials of “eyeMO,” an evaluation on practicality as a screening device for diabetic retinopathy patients, which was carried out at the Joslin Diabetes Center attached to Harvard Medical School in the United States from 2023/1, and two doctor-led clinical trials comparing them with commercially available OCT devices have been completed. Test results are scheduled to be presented at international conferences, and further clinical trials are expected to be conducted.
(4) Business model and market size
As a business model, there is a high possibility that usage fees will be collected every month as a rental service that reduces the initial burden on patients. Also, if insurance is applied, the burden on patients can be drastically reduced, so it is thought that spread will also accelerate. Since there are no root treatments for retinal diseases, once “eyeMO” is used, there is a high possibility that it will continue to be used as long as blindness does not occur, and there is a possibility that it will grow into a stable revenue source as a stock type business.
According to the International Diabetes Federation (IDF), there are approximately 460 million diabetics in the world as of 2019, and it is predicted that it will reach 570 million in 2030 and 700 million in 2045. It is said that diabetes causes various complications, and among them, diabetic macular edema may cause blindness. (Issha) According to the Japan Lifestyle-Related Disease Prevention Association, it is said that there are approximately 10 million diabetics in Japan (including those who are strongly suspected of diabetes), and when the number of patients with diabetic macular edema is estimated from the prevalence rate, it is approximately 500,000 in Japan and 23 million worldwide. Since a root treatment for diabetic macular edema has not yet been developed, it is expected that the number of patients will increase year by year in proportion to the number of diabetic patients, and we believe that there is a good possibility that “eyeMO” will spread as an easy test device. Hypothetically, if the rental fee is 10,000 yen per year, the potential can be expected to be 1.5 billion yen per year if the penetration rate is 30% domestically, and 23 billion yen per year if the penetration rate is 10% worldwide.
(Author: FISCO Visiting Analyst Joe Sato)