Sydnexis announced that its partner Santen received UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for Ryjunea (low-dose atropine 0.1 mg/mL). The approval makes Ryjunea the first approved treatment in the UK to slow myopia progression in children aged 3-14 years with a progression rate of 0.50 D or more per year and severity between -0.50 D to -6.00 D.

The approval follows European Commission authorization and initial launch in Germany earlier this year. Sydnexis’ low-dose atropine eye drop SYD-101 is licensed to Santen for commercialization in Europe, the Middle East, and Africa under the Ryjunea brand name.

The UK approval is supported by the global STAR study. “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.”

The UK approval comes just 2 weeks after the FDA issued a complete response letter for Sydnexis' NDA for the eye drop in the US. Sydnexis said it remains focused on advancing discussions with the FDA and exploring potential next steps to make SYD-101 available to US patients.