Sydnexis Announces Positive CHMP Opinion in Europe for Myopia Drug Candidate SYD-101

Sydnexis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for its proprietary low-dose atropine formulation, SYD-101, for slowing the progression of pediatric myopia.

Santen SA licensed the rights from Sydnexis to commercialize SYD-101 under the brand name Ryjunea in the regions of Europe, Middle East, and Africa (EMEA). Santen SA is the Switzerland-based affiliate of Santen Pharmaceutical Co., a Japan-based company specialized in eye health.

“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,” Perry Sternberg, Chief Executive Officer of Sydnexis, said in a company news release. “The 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.”

The CHMP positive opinion was primarily supported by data from the STAR study, Sydnexis’ 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 that Ryjunea 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.

Myopia is the most common eye disease in children, impacting approximately one-third of children and adolescents worldwide. According to Sydnexis, 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.