Santen announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ryjunea (low-dose atropine 0.1 mg/ml), the first licensed treatment in the UK to slow the progression of myopia in children. The approval follows the European Commission authorization and the first launch in Germany earlier this year, with additional launches in Europe to follow.
Ryjunea is indicated for slowing the progression of myopia in pediatric patients. Treatment may be initiated in children aged 3 to 14 years with a progression rate of 0.5 D or more per year and a severity of –0.5 D to –6.0 D. It is backed by the Phase III STAR study, showing that Ryjunea significantly reduced the annual progression of myopia with an acceptable safety and tolerability profile. The product is licensed from Sydnexis Inc. to Santen's Switzerland-based affiliate, Santen SA, for registration and commercialization across Europe, the Middle East, and Africa. It has received market authorization from the European Commission on June 2, and now from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on October 30.


