■Overview and progress of major development pipelines
1. Wearable myopia device “Kubota glasses”
(1) Myopia mechanism and market size
Kubota Pharmaceutical Holdings ＜4596＞ is focusing on the development of Kubota glasses technology which is expected to have the effect of suppressing or improving the progression of myopia. The types of myopia are classified into refractive myopia, axial myopia, false myopia, nuclear myopia, etc., but most of them are called axial myopia, and it is a mechanism where the retina moves behind the focus due to extension of the ocular axis length, making it difficult to see far away. Therefore, axial myopia can be corrected if the ocular axis length is shortened. Currently, there is no treatment, and vision correction is performed by adjusting the refraction of light with refractive correction (glasses, contact lenses, refractive surgery) and focusing on the retina.
The myopic population continues to increase globally due to lifestyle changes, and it is said to be the most familiar disease. According to the company's data, there is also a forecast that the ratio of myopia in the world population will rise from about 28% in 2010 to about 50% (about 4.7 billion people) in 2050. Since 2020, the WHO (World Health Organization) has issued a warning that myopia is prevalent worldwide due to an increase in stay-at-home hours due to the spread of the novel coronavirus infection (hereinafter, COVID-19) and the spread of smartphones. In particular, the population with severe myopia is predicted to increase by 9.8% to about 930 million people in 2050, and suppressing myopia has also become an international issue.
In particular, in Asian countries, the myopic population is rapidly increasing, and there are many countries where the myopia prevalence rate of people under the age of 20 exceeds 80%, and there is also a forecast that costs related to myopia correction among Asians will reach 450 trillion yen per year in 2050. According to the “School Health Statistics Survey” conducted by the Ministry of Education, Culture, Sports, Science and Technology, the ratio of students with naked eye vision of 1.0 is increasing year by year, and in 2022, high school students account for a majority of 71.6% and middle school students with 61.2%, and even elementary school students, at least 1 in 3 students are myopic. As myopia progresses, it is said that the risk of suffering from serious diseases leading to blindness, such as glaucoma or cataracts, will increase 2 to 5 times compared to orthodontics in the future, and it is also a disease where development of root treatment methods is strongly desired.
There is also a forecast that the global myopia lens market will expand from 24.4 billion US dollars in 2021 to 27.3 billion US dollars in 2025. Currently, if “Kubota Glass,” which is sold as a spectacle-type AR device, is approved as a medical product with an effect of suppressing the progression of myopia, large demand can be expected, and future trends are attracting attention.
(2) How Kubota Glasses Technology works
Kubota glasses technology is an active stimulation technology unique to the company that aims to suppress and treat the progression of myopia by actively applying light stimulation to the retina using AR technology. It is a mechanism that suppresses or shortens eye axis length expansion by projecting an image called myopic defocus with focus in front of the peripheral retina using a micro LED that emits a wide wavelength and brightness like natural light, and suppresses the progression of myopia. Proof of concept tests have already been conducted on humans, and the effect of suppressing eye axis length* has been confirmed. There is clinical trial data targeting children with other companies' products, but the company is the first to confirm the effects by conducting tests on adults.
* At an ophthalmology specialty research institute in the United States, it was announced in 2020/5 that as a result of verifying the effects on the eye axis with a desktop device, which is a prototype using Kubota glasses technology, on 12 subjects aged 21 to 32 with a tendency to myopia, an effect of shortening eye axis length compared to the target eye was confirmed. Also, it was announced in August of the same year that similar effects were obtained with wearable devices targeting 25 test subjects aged 18 to 35.
In 2021, we obtained a medical device manufacturing license in Taiwan and obtained “ISO13485:2016” certification as a medical device design/development company, and although registration of medical devices was completed in the United States in 2022, they will first be sold domestically as spectacle-type AR devices, and then proceed with overseas expansion after increasing the degree of perfection of the product. Furthermore, the company plans to promote development aimed at realizing a world without glasses, such as applying it to smart glasses, smart contact lenses, etc. in the future based on Kubota glasses technology.
(3) Comparison with other companies' products
Various companies are developing devices to suppress the progression of myopia, and there are also products*1 that have already been approved as medical devices in the US, China, etc., and sales have begun. There are multiple products using Myopic Defocus, starting with MiSight, but all of them passively impart light stimulation, which sets it apart from devices that apply AR technology to provide active and effective light stimulation like the company. Therefore, while “Kubota glasses” can only be worn for 1 to 2 hours a day, other companies' products need to be worn for 12 to 15 hours for almost 1 day. The fact that the effect of suppressing the progression of myopia can be obtained by using it for a short period of time can be said to be one of the advantages of “kubota glasses.” Also, when clinical trial data from each company is compared, “kubota glasses” show top class values in myopia progression suppression rate and ocular axis elongation suppression rate data, and clinical trial results suggest that they are superior to other companies' products in terms of efficacy. There are also treatments such as eye drops and orthokeratology*2, but side effects and the magnitude of risk have not spread widely due to the difficulties. Also, surgeries such as LASIK and ICL (intraocular contact lenses) are also an option, but since high invasiveness is a drawback, there is still a risk that eye axis length will increase and eyesight will deteriorate, so it cannot be said that it is a radical treatment.
*1 US Cooper Vision's contact lens “MiSight 1 Day” was approved for sale for the first time in the US in 2019.
*2 Unlike general contact lenses, the shape of the cornea is correctly corrected by wearing specially designed high-oxygen-permeable contact lenses while sleeping, and it is a myopia correction method that allows you to spend time with the naked eye during the day, and was approved in Japan in 2009.
Regarding the safety of “Kubota glasses,” they meet the safety standard group 1 standards of the International Organization for Standardization (ISO15004), which stipulates the safety of optical radiation of ophthalmic optical devices, and “there is no potential risk,” and in addition, ISO13485 pediatric medical device certification requiring higher safety has also been obtained and guaranteed. Since large-scale clinical trials to confirm efficacy are required in order to be sold as a medical device that can display efficacy and effects, it is currently being sold in Japan as an AR device that reproduces outdoor environments, but Kubota glasses technology has received a certain level of evaluation among doctors and scholars who research myopia, and research is progressing.
In 2023, a new joint research agreement was signed with the China Medical University Hsinchu Affiliated Hospital in Taiwan for a prospective intervention trial. It is a test to evaluate the efficacy of each group receiving 0.01% of low-concentration atropine eye drops and the group wearing “kubota glasses” for 45 children with myopia, and the possibility of synergistic effects due to combination therapy (observation period 1 year), and research results are attracting attention. Regarding “Kubota glasses,” they are minimally invasive and highly safe, and in addition to being easy to use and highly effective, and can be attached and detached by oneself from age 6, they are also characterized by being usable in combination with other myopia treatments, and we believe that there is a good possibility that they will develop the market in the future as a myopia progression suppression device.
(Author: FISCO Visiting Analyst Joe Sato)