Ryjunea Approved in UK for Childhood Myopia

Sydnexis has announced that its partner, Santen, has received regulatory approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ryjunea, a low-dose atropine eye drop (0.1 mg/mL) designed to slow the progression of myopia in children. This marks the first treatment approved by the MHRA for pediatric myopia management in the UK.

First MHRA-Approved Myopia Therapy for Children

Ryjunea is indicated for children aged 3 to 14 years who show a myopia progression rate of 0.50 diopters or more per year, with baseline refractive error between -0.50 D and -6.00 D. The therapy provides a much-needed option for early intervention in cases of progressive childhood myopia, a growing public health concern worldwide.

UK Approval Follows European Launch

The UK authorization follows earlier approval by the European Commission and the initial launch of Ryjunea in Germany. Santen holds commercialization rights for the therapy in Europe, the Middle East, and Africa through a licensing agreement with Sydnexis, where the product is marketed under the Ryjunea brand name.

Backed by the Global STAR Study

The MHRA approval is supported by data from the global STAR study, which evaluated the safety and efficacy of low-dose atropine for pediatric myopia. The study provided the foundation for regulatory filings across multiple regions.

“We are thrilled that the MHRA has granted approval of Ryjunea to Santen, marking another important milestone in bringing this innovative therapy to even more patients in need,” said Perry Sternberg, Chief Executive Officer of Sydnexis. “Backed by the global STAR study, this announcement underscores the potential of an approved low-dose atropine solution to address a significant unmet medical need for children with progressive myopia worldwide.”