Santen receives positive CHMP opinion in Europe for Ryjunea for slowing the progression of paediatric myopia

Santen Pharmaceutical Co., Ltd.  announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for Ryjunea (:STN 1012701). Ryjunea is a patented low-dose atropine ophthalmic formulation (0.1mg/mL), licensed from Sydnexis Inc. to Santen’s Switzerland-based affiliate, Santen SA, to commercialize in the regions of Europe, the Middle East, and Africa, for slowing the progression of paediatric myopia. The Marketing Authorization Application (MAA) for Ryjunea was filed in March 2024 to the EMA.

The CHMP opinion was primarily supported by data from the STAR (STudy of Atropine for the Reduction of myopia progression in children) study. Ryjunea met its primary endpoint demonstrating efficacy in slowing the progression of myopia in children at 24 months. The difference between Ryjunea compared to placebo reached statistical significance in terms of annual progression of myopia in the patient population studied.

The primary endpoint was assessed by the mean annual progression rate of myopia at month 24 using the rate of change of the spherical equivalent, which is a simplified representation of an individual’s refractive error. The study results showed a favourable safety and tolerability profile of Ryjunea in the patient population studied. The study was conducted in 852 randomised male and female paediatric participants with myopia between the ages of 3 to 14 years old at the time of study initiation. The STAR study was designed to continue for a total of 48 months and is estimated to be completed in the summer of 2025.

“Ryjunea exemplifies Santen’s dedication to deliver innovative treatment options that meet the needs of patients with myopia in Europe, the Middle East, and Africa. This positive opinion from the CHMP represents a critical milestone in our efforts to make Ryjunea available, supporting early intervention in patients with paediatric myopia, with treatments designed to slow its progression,” commented Peter Sallstig, Chief Medical Officer, Santen.