EC approves Santen’s Ryjunea to slow progression of pediatric myopia

The European Commission has granted market authorization for Japanese ophthalmic drugmaker Santen Pharmaceutical’s (TYO: 4536) Ryjunea, a low-dose atropine eye drop (0.1mg/ml), that slows the progression of pediatric myopia, marking a significant advance in pediatric eye care.

Ryjunea is indicated in children aged three to 14 years at treatment initiation and with myopia progression of 0.5 D or more per year and a severity of -0.5 D to -6.0 D. The product is licensed from Sydnexis to Santen’s Switzerland-based affiliate, Santen SA, for registration and commercialization across Europe, the Middle East and Africa (EMEA).

Santen noted that the approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). It is backed by the Phase III STAR study, a clinical study for treating the progression of pediatric myopia. The study showed that Ryjunea reduced the annual progression of myopia by 30% over two years compared to placebo, with a favorable safety and tolerability profile. Ryjusea was approved by the Japanese regulator last December.