Santen: Santen Pharmaceutical : launches RYJUSEA Mini ophthalmic solution 0.025% Japan's first ophthalmic solution for slowing myopia progression

Santen launches RYJUSEA Mini ophthalmic solution 0.025% Japan's first ophthalmic solution for slowing myopia progression March 18, 2025 - Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced that it will launch RYJUSEA ® Mini ophthalmic solution 0.025% (active ingredient: atropine sulfate hydrate, hereinafter the product) on April 21, 2025. The product is scheduled to be sold as a drug not listed in the National Health Insurance Drug Price Standard and will not be covered by public medical insurance. The product is an ophthalmic solution containing 0.025% atropine sulfate hydrate. In a phase II/III placebo-controlled, double-masked comparative study conducted in Japan on myopia patients aged 5 to 15 years, the results verified that the product was superior to the vehicle in terms of the change from baseline in the cycloplegic objective spherical equivalent at 24 months after administration. Based on these results, Santen applied for manufacturing and marketing approval in February 2024. In December 2024, the product became the first in Japan to be approved for the indication of slowing myopia progression. The product formulation is designed to improve efficacy by increasing the distribution to the posterior sclera, the intended site of drug action, while reducing the risk of mydriasis by minimizing off target distribution to the iris and ciliary body. Additionally, as the product is primarily intended for pediatric patients with mild to moderate myopia and is expected to be used for long-term treatment, it has been developed as a preservative-free, single-use ophthalmic solution. Ippei Kurihara, Head of Japan Business, Global Commercial Strategy at Santen, comments: "Reports suggest that as myopia progresses, quality of life (QOL) declines. 1,2 In the case of high myopia, there is an increased risk of developing complications that may lead to blindness due to visual impairment. 3,4 With the recent worldwide increase in myopia and the increase in the number of people with myopia in Japan, we believe that the need for treatments to slow the progression of myopia is becoming increasingly important. The product is the first treatment in Japan to be approved for slowing myopia progression. We intend to market it as the basis for treatment that slow the myopia progression." Santen, as a specialized company dedicated to eye health, strives to create new treatments 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 RYJUSEA ® Mini ophthalmic solution 0.025% : Product name RYJUSEA ® Mini ophthalmic solution 0.025% Active ingredient Atropine sulfate hydrate Dosage form Limpid and colorless, sterile aqueous ophthalmic solution Indication Slowing myopia progression Dosage Typically 1 drop once a day before bedtime Storage Room temperature Packaging 0.3 mL/bottle, plastic eye dropper vials x 30 (30 vials per aluminum foil pouch) Date of marketing approval December 27, 2024 Date of launch April 21, 2025 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. 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." Moreover, research has shown that patients experiencing high myopia are at an elevated risk for complications that might lead to loss of sight. 3,4 Myopia patients are estimated to reach 39.9% of the world's population by 2030 and 49.8% by 2050. 5 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 2024 school year survey showing 36.8% of elementary school students, 60.6% of junior high school students, and 71.1 % of high school students having this condition. 6 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 References Han X et al, Curr Eye Res . 2023;48(12):1189-1194. Sankaridurg P et al, Invest Ophthalmol Vis Sci . 2021;62(5):2. Morgan IG et al, Lancet . 2012;379(9827):1739-48. Haarman A et al, Invest Ophthalmol Vis Sci . 2020;61(4):49. Holden B et al, Ophthalmology 2016;123(5):1036-42. Ministry of Education, Culture, Sports, Science and Technology: Press Release "Publication of School Health Statistics (Fixed Figures) for the 2024 School Year". https://www.mext.go.jp/content/20250213-mxt_chousa01-000040132_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 . ContactCorporate Communications Santen Pharmaceutical Co., Ltd. E-mail: communication@santen.com Attachments Original document Permalink Disclaimer Santen Pharmaceutical Co. Ltd. published this content on March 18, 2025 , and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 17, 2025 at 23:36:00.752 . March 18, 2025 - Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced that it will launch RYJUSEA ® Mini ophthalmic solution 0.025% (active ingredient: atropine sulfate hydrate, hereinafter the product) on April 21, 2025. The product is scheduled to be sold as a drug not listed in the National Health Insurance Drug Price Standard and will not be covered by public medical insurance. The product is an ophthalmic solution containing 0.025% atropine sulfate hydrate. In a phase II/III placebo-controlled, double-masked comparative study conducted in Japan on myopia patients aged 5 to 15 years, the results verified that the product was superior to the vehicle in terms of the change from baseline in the cycloplegic objective spherical equivalent at 24 months after administration. Based on these results, Santen applied for manufacturing and marketing approval in February 2024. In December 2024, the product became the first in Japan to be approved for the indication of slowing myopia progression. The product formulation is designed to improve efficacy by increasing the distribution to the posterior sclera, the intended site of drug action, while reducing the risk of mydriasis by minimizing off target distribution to the iris and ciliary body. Additionally, as the product is primarily intended for pediatric patients with mild to moderate myopia and is expected to be used for long-term treatment, it has been developed as a preservative-free, single-use ophthalmic solution. Ippei Kurihara, Head of Japan Business, Global Commercial Strategy at Santen, comments: "Reports suggest that as myopia progresses, quality of life (QOL) declines. 1,2 In the case of high myopia, there is an increased risk of developing complications that may lead to blindness due to visual impairment. 3,4 With the recent worldwide increase in myopia and the increase in the number of people with myopia in Japan, we believe that the need for treatments to slow the progression of myopia is becoming increasingly important. The product is the first treatment in Japan to be approved for slowing myopia progression. We intend to market it as the basis for treatment that slow the myopia progression." Santen, as a specialized company dedicated to eye health, strives to create new treatments 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. References 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