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<\/a>\n\u201cThis is an incredible milestone for Sydnexis and comes on the heels of the FDA accepting our NDA for SYD-101 and assigning a PDUFA date of October 23, 2025,\u201d said Perry Sternberg, Chief Executive Officer of Sydnexis. \u201cThe CHMP positive opinion provides further validation of both the significant unmet need and critical importance of early intervention and endorses the potential benefit SYD-101 can provide to millions of pediatric patients with progressive myopia.\u201d\n<\/p>
\nThe CHMP positive opinion was primarily supported by data from the STAR study, Sydnexis\u2019 pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated co-morbidities. Santen reported<\/a> Ryjunea\u00ae<\/sup><\/i> met its EMA primary endpoint demonstrating efficacy in slowing the annual progression rate of myopia in pediatric patients ages 3 to 14 years-old at 24 months.\n<\/p> \n\u201cSanten recognized early on that SYD-101\u2019s novel, proprietary formulation was unique in its ability to deliver superior drug activity, maximum stability, and optimal comfort,\u201d said Patrick Johnson, Ph.D., President of Sydnexis. \u201cThey have been a great partner, and we are excited for Santen to bring SYD-101 to market across multiple continents.\u201d\n<\/p> \nMyopia is the most common eye disease in children, impacting approximately one-third of children and adolescents worldwide. By 2050, global prevalence is projected to increase and affect more than 740 million children and adolescents and 5 billion people in total. Once considered a benign refractive condition, even at low levels, myopia is now associated with many serious irreversible sight-threatening co-morbidities later in life.\n<\/p> \n\u201cI am thrilled about the progress to bring SYD-101 to market for the millions of pediatric patients impacted by this growing epidemic,\u201d said Professor Mark Bullimore, OD, Ph.D. \u201cThe news of CHMP\u2019s positive opinion should have a huge impact in Europe, where low-dose atropine has been largely unavailable.\u201d\n<\/p> \nAbout Sydnexis, Inc.:\n<\/p>