Santen Launches Ryjunea^® in Germany for the Treatment of Pediatric Myopia¹

July 22, 2025 - Osaka, Japan – Following European Commission approval on June 2, 2025, Santen Pharmaceutical Co., Ltd. (hereinafter Santen) today announced that Ryjunea^® (development code: STN1012701), is now available in Germany. Germany is the first market to launch Ryjunea^®, with other launches across Europe to follow.

Pediatric myopia, or short-sightedness, is on the rise globally, with increasing screen time and reduced time spent outdoors contributing to worsening vision in young people.^2-5 Myopia progression is typically fastest in younger children, so treatment is needed as early as possible to slow this progression and to reduce the risk of serious eye health complications later in life.^6-8 Parents and pediatricians can play an important role in identifying the issue early.⁹ At the same time, ophthalmologists can intervene to proactively control myopia, helping to reduce myopia risks and support children’s overall social and physical well-being.⁸

Low-dose atropine eyedrops have been shown in clinical studies to be effective in slowing myopia progression.^10-11 Still, to date, patients have been dependent on compounded formulations.^10,12 Ryjunea^® is the first EU-approved medicinal treatment that gives eye specialists a new option to slow down myopia progression and help protect children’s vision for the future.¹

With more than 130 years’ experience in eye health, Santen will continue to work with healthcare professionals, patient organizations, and policymakers to address the growing burden of childhood myopia. The launch of Ryjunea^® strengthens Santen’s dedication to early intervention and better outcomes for children with myopia.

RYJUSEA^® Mini ophthalmic solution 0.025%, Japan’s first approved eye drop from Santen for slowing myopia progression containing the same active ingredient atropine sulfate hydrate as Ryjunea^®, was launched in April 2025.

References

1. Ryjunea^®SmPC, June 2025: Union Register of medicinal products - Public health - European Commission
2. Jones LA, et al. Invest Ophthalmol Vis Sci. 2007;48:3524–3532.
3. Ip JM, et al. Invest Ophthalmol Vis Sci. 2008;49:2903–2910.​
4. Holden BA, et al. Ophthalmology. 2016;123:1036–1042.​
5. Liang J, et al. Br J Ophthalmol. 2024:bjo–2024–325427
6. Tricard D, et al. Br J Ophthalmol. 2022;106:1104-1109.
7. Hohberger, A., et al. Frontiers in Medicine. 11 (2024): 1483069
8. Karuppiah, V et al. Singapore Med J. 62 (2021): 63-68
9. Qian, Y., & Lu, P. Ophthalmology and Therapy. 2024: 13:12:3095-3109.
10. Tsai HR, et al. J Clin Med. 2021;10:3766.
11. Lee SH et al. J Clin Med. 2024;13:1506
12. Morgan IG et al, Lancet. 2012;379(9827):1739-48.

About Ryjunea^®
Ryjunea^® is a registered trademark of Santen Pharmaceutical Co., Ltd, approved by the European Commission. Ryjunea^® is indicated for slowing the progression of myopia in pediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D. It is backed by the Phase III STAR study, showing that Ryjunea^® significantly reduced the annual progression of myopia with a favorable safety and tolerability profile. As a low-dose atropine eye drop, administered once daily at bedtime, it provides a convenient way to manage myopia that integrates easily into a child’s routine. The product is licensed from Sydnexis Inc. to Santen’s Switzerland-based affiliate, Santen SA, for registration and commercialization across Europe, the Middle East, and Africa (EMEA). It has received market authorization from the European Commission on June 2, 2025.

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.

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