Japan-based Santen Pharmaceutical Co., Ltd. announced that it has received marketing approval from the European Commission (EC) for its low-dose atropine eye drops Ryjunea (0.1 mg/mL). The product is indicated to slow myopia progression in children.
Mechanism and Approval Basis
Ryjunea, with atropine sulfate as the active ingredient, controls myopia progression by inhibiting axial elongation. The EC’s approval is based on results from the Phase III STAR study. The study demonstrated a 30% reduction in annual myopia progression compared to placebo over 2 years, along with a favorable safety and tolerability profile.
Significance
Ryjunea is the first pharmacological treatment for pediatric myopia control in the European Union (EU). It offers an adherence-friendly option for long-term management of myopia in children.-Fineline Info & Tech
