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European Commission approves low-dose atropine eye drop Ryjunea from Santen

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Key Takeaways

  • Ryjunea, a low-dose atropine eye drop, is approved for pediatric myopia in children aged 3 to 14 years.
  • The Phase III STAR study demonstrated a 30% reduction in myopia progression over two years with Ryjunea.
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(Image Credit: AdobeStock/ugiss)

(Image Credit: AdobeStock/ugiss)

In a press release, Santen Pharmaceutical Co., Ltd. announced the European Commission (EC) granted marketing authorization 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 pediatric 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 the 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 pediatric myopia. Research findings demonstrated that the low-dose atropine drop reduced the annual progression of myopia by 30% over 2 years compared to 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 endpoint in the trial, demonstrating efficacy in slowing the annual progression rate of myopia in pediatric patients ages 3 to 14 years old at 24 months. The trial is now completing randomized withdrawal for exploratory endpoints 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 United States, the Food and Drug Administration 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-

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