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.
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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.”
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By GlobalDataMyopia 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.
