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

The EMA decision and subsequent EC approval are based on the Phase III STAR study of atropine therapy for paediatric myopia. Image credit: ©xbrchx – stock.adobe.com

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 to placebo, the company said. The safety and tolerability profile of the treatment was favourable.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 paediatric patients ages 3 to 14 years old at 24 months. The trial is now completing randomised 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

In a press release, Sydnexis shared comments from Donny Suh, MD, a paediatric ophthalmologist and chief of paediatric ophthalmology and strabismus at the Gavin Herbert Eye Institute, University of California, Irvine. “The benefits of low-dose atropine have long been recognised in the eye care community, but we now finally have an approved and thoroughly vetted treatment option," Dr Suh said.³ "This marks a new era in our ability to slow the progression of myopia and protect the vision of millions of children worldwide.”

Peter Sallstig, MD, chief medical officer at Santen, said it was crucial for patients and parents to have an “evidence-based” interventional strategy for paediatric 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 commercialisation 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-

3. Sydnexis Announces European Commission Approval of SYD-101, the First and Only Pharmaceutical Treatment for Slowing the Progression of Pediatric Myopia. Press release. Sydnexis, Inc. Published June 5, 2025. Accessed June 5, 2025.