The European Commission (EC) has granted market authorization for Santen’s RYJUNEA®, a low-dose atropine eye drop (0.1 mg/ml), which slows the progression of pediatric myopia. Until now, no approved pharmacological treatment has been available in the EU to slow the progression of myopia.
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 Inc. to Santen’s Switzerland-based affiliate, Santen SA, for registration and commercialization across Europe, the Middle East and Africa (EMEA).
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), and 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 percent over two years compared to placebo, with a favorable safety and tolerability profile.
“For families, watching their child’s vision worsening year after year can be deeply worrying,” said Peter Sallstig, Chief Medical Officer at Santen. “RYJUNEA offers the opportunity to act early. As a low-dose atropine eye drop, administered once daily at bedtime, it provides a convenient way to manage myopia that integrates easily into a child’s routine.”
