Germany serves as European launch point for low-dose atropine from Santen (Ryjunea)

Santen announced it will launch its low-dose atropine formulation (Ryjunea) in Germany, following its approval from the European Commission (EC) in June for myopia management. The company characterised its rollout as an exciting step in the battle against the growing paediatric myopia epidemic, which impacts patients and families across the globe. Additional launches across Europe are expected to follow soon, though the company did not disclose the timeline. Expansion is also planned for the Middle East and Africa.¹

While atropine has shown to slow myopia progression effectively in clinical studies, this formulation of low-dose atropine is the first to pursue approval from global regulatory bodies for myopia management. Until the time of this launch—and still in countries outside of Germany—eye care providers are forced to rely on compounded formulations. While still safe and effective, compounded versions allow for human error, which may affect the success of myopia management.

As previously reported, the SYD-101 formulation of atropine is licensed by Santen SA, based in Switzerland, from Sydnexis Inc, which is based in California.² It is indicated for slowing the progression of myopia in children aged 3-14 years with -0.50 diopters (D) to -6.00 D of error and a progression rate of 0.50 D per year. The EC decision was based on the phase 3 STAR study, in which the low-dose atropine formulation significantly reduced the progression of myopia while maintaining safety and tolerability.³ The company reported a 30% reduction in myopia progression over 2 years compared to placebo.

While the formulation has received approval from the EC² and a positive opinion from the European Medicines Agency (EMA) and its Committee for Medicinal Products for Human Use (CHMP),⁴ Sydnexis is still awaiting FDA decision in the United States.⁵ Issued in April 2025, the EMA and CHMP positive opinion was based on the same data from the STAR study.

Phase 3 STAR study design

The multicentre, randomised, double-masked, vehicle-controlled STAR study investigated the SYD-101 formulation of atropine in children with myopia aged 3 to 14 years.³ The myopic error was required to be between -0.50 D and -6.00 D at the beginning of the trial. Recruitment took place across the US and Europe, and the investigators reported that the population was diverse and representative of children across both constituencies. The participant pool was largely female.

Participants were randomised to receive SYD-101 0.1%, SYD-101 0.3%, or a vehicle drop, but the allocation was stratified across age groups and spherical equivalent (SE) categories. Each participant was dosed nightly in both eyes, and returned for clinic visits at months 3, 6, 12, 18, 24, 30 and 36. Patients were randomised again to cease treatment at month 36 to measure myopic rebound after discontinuation of treatment.

In the end, 847 patients were randomised to vehicle (n = 282), 0.01% (n = 282) and 0.03% (n = 283). The mean age of each group was 10.4, 10.4 and 10.2, respectively. The mean baseline SE was -2.70 D, -2.50 D and -2.44 D, respectively.³

Global approval of atropine

Sydnexis submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA) for the same formulation of atropine and based on the same phase 3 STAR study data. As of March, the company has received acceptance of the NDA and a Prescription Drug User Fee Act (PDUFA) action date of October 23, 2025, from the US FDA.⁵ Santen SA will lead registration and commercialization efforts throughout Europe, the Middle East, and Africa while Sydnexis tackles the United States.¹

Additionally, Santen has obtained manufacturing and marketing approval in Japan for mini ophthalmic solution 0.025% (Ryjusea), which utilises the same active molecule as Ryjunea, atropine sulfate hydrate. It is the first myopia management ophthalmic solution to be approved for production and marketing in Japan. There, it will be sold as a drug not listed in the National Health Insurance Drug Price Standard and is not covered by insurance.⁶ Ryjusea launched in Japan in April 2025.¹

References

1. Santen Launches Ryjunea^® in Germany for the Treatment of Pediatric Myopia. Santen. Press release. Published July 22, 2025. Accessed July 22, 2025. https://www.santen.com/en/news/2025/2025_1/20250722

2. Hayes H. European Commission approves low-dose atropine eye drop Ryjunea, Santen announces. Optometry Times. Published June 5, 2025. Accessed July 22, 2025. https://www.optometrytimes.com/view/european-commission-approves-low-dose-atropine-eye-drop-ryjunea-santen-announces

3. Johnson P, Widder K, Cheetham J, Kirkeby L. Methods and baseline of a large, multicenter, phase 3 study with low-dose atropine (SYD-101) for the treatment of myopia progression in over 800 children (STAR Study). Invest. Ophthalmol. Vis. Sci. 2025;66(8):2825.

4. EMA grants positive CHMP opinion for low-dose atropine SYD-101. Optometry Times. Published April 3, 2025. Accessed July 22, 2025. https://www.optometrytimes.com/view/ema-grants-positive-chmp-opinion-for-low-dose-atropine-syd-101

5. FDA accepts NDA for low-dose atropine from Sydnexis. Optometry Times. Published March 11, 2025. Accessed July 22, 2025. https://www.optometrytimes.com/view/fda-accepts-nda-for-low-dose-atropine-from-sydnexis

6. 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. Santen. Press release. Published December 27, 2024. Accessed July 22, 2025. https://www.santen.com/en/news/2024/2024_1/20241227