On August 25, Kubota Pharmaceutical Holdings announced the success of a proof of concept (POC) trial of Kubota Glasses, a wearable myopia device based on unique active stimulation technology.
Known as Kubota Glasses Technology, this proprietary technology aims to control and reverse the progress of myopia by stimulating the retina with artificial light. It is developed by Kubota Vision, Inc., a subsidiary of Kubota Pharmaceutical.
The clinical trial was conducted by Manhattan Vision Associates and the Institute for Vision Research, an ophthalmology research institute in the United States. 25 trial participants with myopia, aged 18 to 35, put on a wearable device using Kubota Glasses Technology for several hours. The effect on the eye's axial length (the length from the cornea to the retina) was then measured. The researchers found that the eye decreased in axial length compared to the control eye.
Myopia is expected to affect about half the global population by 2050. The rise of myopia has been particularly dramatic in East Asian countries such as Japan, China, Hong Kong, Taiwan, South Korea and Singapore. There is data indicating that 96.5% of 19-year-old males in Seoul are myopic. In March 2019, the Ministry of Education, Culture, Sports, Science and Technology released the results of its School Health Statistics Survey. The survey found that, for students from elementary school to high school, the proportion with an uncorrected visual acuity of at least 1.0 was at the lowest rate ever reported.
There are a number of types of myopia, including refractive myopia, axial myopia, pseudomyopia and myopia related to nuclear cataracts. Most cases are diagnosed as axial myopia, which is thought to be caused by an increase in the eye's axial length. It is said that when the axial length of the eye increases, the focal point in the eye shifts in front of the retina, making it difficult to see long distances. The progress of myopia also increases the risk for glaucoma-related visual field loss, cataracts, retinal detachment, macular degeneration and other complications. Considering this, the rising number of cases of severe myopia is a serious social issue. Nonetheless, no medical treatment for myopia has obtained pharmaceutical approval in Japan.
Kubota Pharmaceutical Holdings is proceeding with the development of Kubota Glasses. The company aims to complete a prototype by the end of 2020 and achieve commercialization by the end of 2021. The recent clinical trial was a proof of concept (POC) using a wearable device; it was not a clinical trial for the purpose of obtaining approval to manufacture and sell the technology as a medical device.
A summary of the clinical trial was registered on clinicaltrials.gov on June 4.