European Commission Approves Santen’s Ryjunea^® to Slow Progression of Paediatric Myopia

 

June 5, 2025 – Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced that the European Commission (EC) has granted market authorization for Santen’s Ryjunea^® (development code: STN1012701), low-dose atropine eye drop (0.1 mg/ml), that slows the progression of paediatric myopia, marking a significant advance in paediatric eye care.

Ryjunea^® is indicated in children aged 3 to 14 years at treatment initiation and with myopia progression of 0.5 D^* or more per year and a severity of -0.5 D to -6.0 D. 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).

The approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). It is backed by the Phase III STAR study, a clinical study for treating the progression of paediatric myopia. The study showed that Ryjunea^® reduced the annual progression of myopia by 30% over 2 years compared to placebo, with a favourable safety and tolerability profile.¹

Myopia, or short-sightedness, often begins in early childhood and can progress rapidly.² If left unmanaged, it increases the risk of serious eye conditions later in life.^3,4 It can impact a child’s overall well-being, including their ability to participate in daily activities and learning.^{5, 6} In Europe, approximately 1 in 3 children and adolescents are projected to be affected by 2050.⁷ Myopia is typically corrected with single-vision glasses or lenses which correct the refractive error but do not address its progression. Until now, no approved pharmacological treatment has been available in the Europe to slow the progression of myopia.

“With this approval, ophthalmologists now have an evidence-based medication to help slow the progression of myopia”, said Peter Sallstig, Chief Medical Officer at Santen. “For families, watching their child’s vision worsening year after year can be deeply worrying. Ryjunea^® offers the opportunity act early. 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.”

“Bringing this treatment to EU countries marks a significant milestone for our efforts to address childhood myopia across the region”, said Marianthi Psaha, Head of Europe, Middle East and Africa Business at Santen. “It reflects our commitment to preserve and protect sight for people around the world – and underscores our mission to bring meaningful innovation to patients, starting at childhood.”

With more than 130 years’ experience in eye health, Santen is focused on helping people maintain and improve their vision across all stages of life. The launch of Ryjunea^® strengthens Santen’s dedication to early intervention and better outcomes in paediatric eye care.

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

References

1. Santen. STAR. Data on file. 2024.
2. Karuppiah, Vijaya, et al. Singapore medical journal. 62.2 (2021): 63.
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. Congdon N, et al. Community Eye Health. 2019;32:7-8.
6. Dudovitz RN, et al. Matern Child Health J. 2016;20:974-83
7. Liang J, et al. Br J Ophthalmol. 2024:bjo-2024-325427.

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