US-based biopharmaceutical company Sydnexis has developed SYD-101, a low-dose atropine formulation designed to slow the progression of paediatric myopia. The European Commission (EC) has granted marketing authorisation for Ryjunea, the brand name under which Santen, a Japan-based eye health company, will commercialise SYD-101 across Europe, the Middle East and Africa (EMEA).

This approval marks a key development in paediatric eye care, making Ryjunea the first and only approved pharmaceutical treatment option for myopia progression in EU countries. The EC authorisation follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The marketing authorisation is based on data from the STAR study, which evaluated the safety and efficacy of the low-dose atropine formulation in children aged three to 14 years.

Santen has licensed the rights to commercialise SYD-101 in the EMEA region from Sydnexis. The paediatric eye care product will be marketed under the brand name Ryjunea.

Sydnexis CEO Perry Sternberg said: “This marks a significant milestone for Sydnexis and, most importantly, for paediatric patients with progressive myopia, their families, and physicians. 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.”

Founded in 2014, Sydnexis is a privately held, pre-commercial biopharmaceutical company. The company recently completed its three-year primary endpoint in the Phase 3 clinical trial for its low-dose atropine formulation. The clinical trial is now in its fourth-year randomised withdrawal phase for exploratory endpoints, with third-year results to be announced after the fourth year concludes.

Sydnexis is backed by investors Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital.

Sydnexis president Patrick Johnson added: “The EU approval of Ryjunea validates the compelling safety and efficacy data generated from our landmark STAR study. We are excited about our continued interactions with the FDA leading up to our October 23 PDUFA date.”

Correction: An earlier version of this article incorrectly stated that Sydnexis received the EC marketing authorisation for SYD-101. In fact, the authorisation was granted to Santen, which has licensed the rights to commercialise SYD-101 in Europe, the Middle East, and Africa. Sydnexis is the developer of the treatment.