Shots:
- The EC has approved SYD-101 to slow pediatric myopia progression; NDA is under the US FDA’s review (PDUFA: Oct 23, 2025)
- Approval was based on P-III (STAR) trial evaluating SYD-101 to reduce pediatric myopia progression & risk of associated co-morbidities in pts (3-14yrs. at trial initiation), which met its 3yr. 1EP, with third-year data to be reported after completing the ongoing fourth-year exploratory phase of the study
- Additionally, Santen has licensed SYD-101 rights from Sydnexis for Europe, Middle East, & Africa (EMEA) & will commercialize the product under the brand name Ryjunea
Ref: Business Wire | Image: Sydnexis | Press Release
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