The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for SYD-101 – a proprietary low-dose atropine formulation developed by Sydnexis, for slowing the progression of paediatric myopia.
The CHMP positive opinion was primarily supported by data from the STAR (STudy of Atropine for the Reduction of myopia progression in children) study, Sydnexis’ pivotal Phase 3 clinical trial evaluating efficacy of SYD-101 and the risk of associated co-morbidities.
I am thrilled about the progress to bring SYD-101 to market for the millions of paediatric patients impacted by this growing epidemic
Santen – which has the licence to commercialise SYD-101 under the brand name Ryjunea in the regions of Europe, Middle East, and Africa (EMEA) – reported Ryjunea met its EMA primary endpoint demonstrating efficacy in slowing the annual progression rate of myopia in paediatric patients ages 3 to 14 years-old at 24 months.
Professor Mark Bullimore welcomed the opinion saying, “I am thrilled about the progress to bring SYD-101 to market for the millions of paediatric patients impacted by this growing epidemic… The news of CHMP’s positive opinion should have a huge impact in Europe, where low-dose atropine has been largely unavailable.”
