Atropine Sulfate

The European Commission granted marketing authorisation for Santen Pharmaceutical’s low-dose atropine eye drop Ryjunea to slow paediatric myopia progression, marking the first and only approved therapy for this indication in the EU.Ryjunea — available as a 0.1 mg/mL ophthalmic solution for once-daily administration — is specifically indicated for children aged 3 to 14 years at treatment initiation, having myopia progression of ≥0.5 D per year and a severity of -0.5 D to -6.0 D.Santen secured rights to commercialise the atropine formulation, codenamed SYD-101, in the EU, Middle East and Africa under a licensing agreement with Sydnexis in 2021. “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. The EU clearance — which closely follows a positive opinion adopted by the European drug advisory panel in April — is supported by the pivotal Phase III STAR study, which showed that Ryjunea slowed annual myopia progression by 30% over two years compared with placebo in children aged 3 to 14 years.Sydnexis, which continues to hold US rights to the drug, successfully completed an FDA regulatory filing in March, with a decision expected later this year. “We are excited about our continued interactions with the [FDA] leading up to our October 23 PDUFA date," remarked Patrick Johnson, president of Sydnexis.Santen’s 0.025% variant of the product was earlier approved in Japan and launched in April under the name Ryjusea Mini to slow myopia progression.

The authorisation in the EU signifies a step forward in eye care for paediatric patients. Credit: chaponta/Shutterstock. The European Commission (EC) has granted marketing authorisation to Sydnexis for its low-dose atropine formulation SYD-101, designed to slow the progression of paediatric myopia [shortsightedness]. The decision positions the therapy as the first and only approved pharmaceutical treatment for myopia progression within the European Union (EU), signifying a step forward in eye care for paediatric patients. The authorisation is supported by the data from the company’s pivotal Phase III STAR trial assessing SYD-101 in slowing the advancement of paediatric myopia and its associated risks in paediatric patients aged three to 14 years at the start of treatment. Following a positive opinion received in April 2025 from the European Medicines Agency’s Committee for Medicinal Products for Human Use, Japan-based eye health company Santen obtained the rights to commercialise the therapy under the brand name Ryjunea in Europe and the Middle East and Africa region. Sydnexis CEO Perry Sternberg stated: “This marks a significant milestone for Sydnexis and, most importantly, for paediatric patients with progressive myopia, their families and physicians as the first and only approved pharmaceutical treatment option in Europe. “This approval is an endorsement of the potential benefit SYD-101 can provide to millions of patients globally and reinforces the critical importance of early intervention.” GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Myopia is a widespread eye condition affecting children, estimated to impact roughly one-third of young individuals globally. Founded in 2014, Sydnexis is a US-based company and has recently concluded the three-year primary endpoint of its Phase III trial of the low-dose atropine formulation. The trial is currently in its fourth year, focusing on randomised withdrawal for exploratory endpoints, with third-year outcomes expected to be released after the fourth year’s completion. Sydnexis is backed by investment from RA Capital, Visionary Ventures, Bluestem Capital and Longitude Capital. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now