RYJUSEA^🄬 Mini ophthalmic solution 0.025% (atropine sulfate ophthalmic solution), Japan’s first ophthalmic solution for slowing myopia progression, receives approval for manufacturing and marketing

December 27, 2024 - Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has obtained manufacturing and marketing approval in Japan for RYJUSEA^🄬 Mini ophthalmic solution 0.025% (generic name: atropine sulfate hydrate; development code: STN1012700 / DE-127) (hereinafter the product) to slow the progression of myopia. The product is the first myopia progression-suppressing ophthalmic solution to be approved for production and marketing in Japan. The product is planned to be sold as a drug not listed in the National Health Insurance Drug Price Standard and is not considered insurance-covered healthcare.

Myopia is a condition in which the focal point for distant objects is in front of the retina, instead of directly on it and is primarily caused by elongation of the axial length (front to back) of the eye, making it difficult to focus on distant objects and resulting in blurred vision. Myopia progresses as the body matures. It is irreversible and affects patient quality of life (QOL).^1,2 If progress continues, there is reportedly a higher risk of experiencing severe complications later on, which may result in blindness from high myopia-induced visual impairment.^3,4 Myopia progresses more rapidly each year in younger age groups,⁵ particularly those of school age.⁶ As such, it is considered crucial to suppress the progression of myopia during this period. Myopia is generally corrected using eyeglasses or contact lenses, and various treatments are being used to suppress the progression of myopia, but none of these treatments have been approved for the suppression of myopia progression in Japan. Santen developed this product with the aim of obtaining the first approval in Japan for an ophthalmic treatment that suppresses the progression of myopia.

The product, an ophthalmic solution applied once a day before bedtime, is a product jointly developed by Santen and the Singapore Eye Research Institute (SERI), a national ophthalmic and vision research institute in Singapore, for the purpose of suppressing the progression of myopia. It contains 0.025% atropine sulfate hydrate. Atropine, a reversible antagonist of muscarinic receptors, is believed to inhibit the activation of muscarinic receptors and prevent the thinning of the sclera by acting directly or indirectly on the retina or sclera, thereby suppressing the elongation of the ocular axis.⁷ This product is a mini-disposable ophthalmic solution that does not contain preservatives to ensure safety for long-term use, especially in children.

In a phase II/III placebo-controlled, double-masked comparative study conducted in Japan on patients with myopia, the efficacy of the product was investigated by its superiority to the placebo group in terms of the change from baseline in the cycloplegic objective spherical equivalent at 24 months after administration. In addition, the product group showed a significant difference compared to the placebo group in the change from baseline in ocular axial length at 24 months after administration. Based on the above, the product demonstrated an effect of slowing myopia progression. Also, the product’s effectiveness was shown to be sustained over a three-year period. The most common adverse drug reaction in the study was photophobia, which occurred in 9.0% (11/122 cases).

Myopia patients are estimated to reach 39.9% of the world’s population by 2030 and 49.8% by 2050.⁸ The School Health Statistics Survey conducted by the Japanese Ministry of Education, Culture, Sports, Science and Technology suggests that the percentage of people with unaided visual acuity of less than 1.0 is increasing year by year, with the results of the 2023 school year survey showing 37.7% of elementary school students, 60.9% of junior high school students, and 67.8% of high school students having this condition.⁹ The increase in myopia in recent years is thought to be due to lifestyle changes, particularly a decrease in time spent outdoors combined with an increase in near-work activities (those that involve looking at things close up for extended periods), such as reading, studying, and using digital devices.^3,4

Peter Sallstig, Chief Medical Officer at Santen, comments: “The rising prevalence of myopia among individuals is a significant societal concern, not only in Japan but globally as well. The receipt of manufacturing and marketing approval for RYJUSEA^🄬 Mini ophthalmic solution 0.025% is a significant milestone in the medical management of myopia, as the drug is the first therapeutic product with the efficacy of suppressing myopia progression to be approved in Japan. Myopia is a new disease area for Santen, and together with another atropine ophthalmic solution under development, we expect global peak sales of approximately 60 billion yen. Santen pursues eye health for people, and we will continue prioritizing the introduction of new therapies for myopia sufferers worldwide, starting with Japan.”

Santen strives to create new medicines that contribute to treating patients and improving the QOL of as many patients as possible, with the aim of realizing a society in which people around the world can experience Happiness with Vision.

About myopia
Light is refracted after entering the eye while passing through the cornea and the crystalline lens, resulting in an image projected on the retina. Myopia denotes a vision condition where unadjusted incoming light focuses in front of the retina. This condition is believed to be mainly caused by the extension of the eyeball from the front to the back. The degree of myopia is expressed in the spherical equivalent refractive error (unit: diopters [D]). Japan Myopia Society classifies myopia according to the value of the spherical equivalent refractive error, defining the condition of an eye with a spherical equivalent refractive error of ≤ −0.5 D as “myopia” and the condition of an eye with a spherical equivalent refractive error of ≤ −6.0 D as “high myopia.” 

References

1. Han X et al, Curr Eye Res. 2023;48(12):1189-1194.
2. Sankaridurg P et al, Invest Ophthalmol Vis Sci. 2021;62(5):2.
3. Morgan IG et al, Lancet. 2012;379(9827):1739-48.
4. Haarman A et al, Invest Ophthalmol Vis Sci. 2020;61(4):49.
5. Sankaridurg PR et al, Eye (Lond). 2014;28(2):134-41.
6. Takeuchi M et al, Sci Rep. 2022;12(1):2879.
7. Upadhyay A et al, Eye Contact Lens 2020;46(3):129-135.
8. Holden B et al, Ophthalmology 2016;123(5):1036-42.
9. Ministry of Education, Culture, Sports, Science and Technology: Press Release “Publication of School Health Statistics (Fixed Figures) for the 2023 School Year”.
   https://www.mext.go.jp/content/20241127-mxt_chousa02-000038854_1.pdf

About Santen
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen’s mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience “Happiness with Vision.”
For more information, please visit Santen’s website https://www.santen.com/en.

About Singapore Eye Research Institute
Established in 1997, Singapore Eye Research Institute (SERI) is Singapore’s national research institute for ophthalmic and vision research. SERI’s mission is to conduct high-impact eye research that prevents blindness, low vision and major eye diseases common to Singaporeans and Asians. Over the last decade, SERI has conducted landmark research projects that have led to tangible outcomes, patient benefits, and success stories. It has paved the way for significant improvements in how eye diseases are treated and prevented, not just for Singaporeans or Asians, but on a global scale.
SERI has grown from a founding team of five in 1997 to a faculty of more than 249 staff, encompassing clinician scientists, scientists, research fellows, PhD students and support staff. This makes SERI one of the largest research institutes in Singapore, as well as the largest eye research institute in the Asia Pacific region. SERI has also over 255 adjunct faculties from various eye departments, biomedical institutes and tertiary centers in Singapore.
SERI has published an impressive array of 5,877 scientific papers, and has secured external peer-reviewed competitive grants. As of November 2024, SERI’s faculty has been awarded with more than 1,295 national and international prizes and filed 188 patents.
As the research institute of the SNEC, and directly affiliated to the Yong Loo Lin School of Medicine, National University of Singapore, as well the Duke-NUS Medical School, SERI undertakes vision research in collaboration with local clinical ophthalmic centers and biomedical research institutions, as well as major eye centers and research institutes throughout the world.
SERI ranks first globally in terms of eye publications per capita, far ahead of the US, UK and Japan. With its impressive publication track record, SERI is comparable to renowned eye institutes, both regionally and internationally. Please see www.seri.com.sg.

Contact
Corporate Communications
Santen Pharmaceutical Co., Ltd.
E-mail: communication@santen.com