European Commission approves low-dose atropine eye drop Ryjunea, Santen announces

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In a press release, Santen Pharmaceutical Co, Ltd announced the European Commission (EC) granted marketing authorisation for its 0.1 mg/mL atropine eye drop. The low-dose drop, marketed as Ryjunea, is licensed from California-based Sydnexis Inc to Santen SA, based in Switzerland.¹ In April, the European Medicines Agency (EMA) and its Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the atropine drop as a therapy for paediatric myopia.²

According to the press release from Santen, the drop, previously known by the development code STN1012701 or as SYD-101, is approved for children aged 3 to 14 years at initiation of treatment. Ryjunea is indicated for myopia progression of 0.5 diopters (D) or more per year and a severity of -0.5 D to -6.0 D.¹

The CHMP decision and subsequent EC approval announcement are based on the phase III STAR study, a clinical study for treating the progression of paediatric myopia. Research findings demonstrated that the low-dose atropine drop reduced the annual progression of myopia by 30% over 2 years compared with placebo, the company said. The safety and tolerability profile of the treatment was favorable.¹

In the STAR study, the drop successfully reached its 3-year primary end point in the trial, demonstrating efficacy in slowing the annual progression rate of myopia in paediatric patients aged 3 to 14 years at 24 months. The trial is now completing randomized withdrawal for exploratory end points ahead of its fourth year. According to a prior announcement from Sydnexis, third-year results will be announced upon completion of the fourth year of the study.²

Peter Sallstig, MD, chief medical officer at Santen, said it was crucial for patients and parents to have an “evidence-based” interventional strategy for pediatric myopia. “For families, watching their child’s vision worsening year after year can be deeply worrying,” he said. “Ryjunea offers the opportunity to 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.”

Santen SA will lead registration and commercialization efforts throughout Europe, as well as in the Middle East and Africa.¹ In the US, the FDA issued Ryjunea a PDUFA date of October 23, 2025.²

References

1. European Commission Approves Santen’s Ryjunea® to Slow Progression of Paediatric Myopia. Press release. Santen Pharmaceutical Co., Ltd. Published June 5, 2025. Accessed June 5, 2025. https://www.santen.com/en/news/2025/2025_1/20250605
2. Hayes, H. EMA grants positive CHMP opinion for low-dose atropine SYD-101 (Ryjunea, Sydnexis). Ophthalmology Times Europe. Published April 1, 2025. Accessed June 5, 2025. https://europe.ophthalmologytimes.com/view/ema-grants-positive-chmp-opinion-for-low-dose-atropine-paediatric-myopia-syd-101-ryjunea-sydnexis-