Santen has announced that the European Commission (EC) has granted market authorization for Sydnexis Inc.’s SYD-101 , a low-dose atropine eye drop (0.1 mg/mL), to slow the progression of pediatric myopia. Being commercialize by Santen as Ryjunea, it is indicated for children aged 3 to 14 years at treatment initiation, with myopia progression of 0.5 D or more per year and severity between –0.5 D and –6.0 D. The product is licensed from Sydnexis Inc. to Santen’s affiliate, Santen sa, for registration and commercialization across Europe, the Middle East, and Africa.
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EC Approves Santen’s Ryjunea to Slow Progression of Pediatric Myopia
The product is indicated for children aged 3 to 14 years at treatment initiation, with myopia progression of 0.5 D or more per year and severity between –0.5 D and –6.0 D.
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June 11, 2025