Sydnexis Receives Positive CHMP Opinion for SYD-101 to Treat Pediatric Myopia in Europe
Sydnexis has announced a significant milestone with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) granting a positive opinion for its low-dose atropine formulation, SYD-101. This drug candidate is aimed at slowing the progression of pediatric myopia, a growing global concern.
Commercialization in EMEA Under the Brand Name Ryjunea
Santen SA, a Switzerland-based affiliate of Santen Pharmaceutical Co. Ltd. in Japan, holds the exclusive commercialization rights for SYD-101 in Europe, the Middle East, and Africa (EMEA). The product will be marketed under the brand name Ryjunea.
“This 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,” said Perry Sternberg, CEO of Sydnexis.
“The CHMP positive opinion provides further validation of the significant unmet need and underscores the potential benefit SYD-101 can offer to millions of pediatric patients with progressive myopia.”
Clinical Evidence from Phase 3 STAR Study
The CHMP opinion is primarily based on the results of Sydnexis’ pivotal Phase 3 STAR trial, which evaluated the efficacy and safety of SYD-101 in slowing the progression of myopia in children aged 3 to 14 years.
Santen reported that Ryjunea met its primary endpoint as defined by the EMA, demonstrating a significant reduction in the annual progression rate of myopia at 24 months of treatment.
Addressing a Growing Global Health Challenge
Myopia is now recognized as the most common eye disease in children, affecting around one-third of the global pediatric population. Sydnexis noted that by 2050, myopia is projected to affect:
• More than 740 million children and adolescents, and
• Over 5 billion people globally
Once viewed as a benign refractive error, myopia is increasingly linked to serious, irreversible, sight-threatening complications later in life—even at low levels.
