Sydnexis Announces Positive CHMP Opinion in Europe for SYD-101 for Slowing the Progression of Pediatric Myopia

Santen is Sydnexis’ Licensing Partner to Commercialize SYD-101 within the EMEA Region upon issuance of a Marketing Authorization by the European Commission

DEL MAR, Calif.--(BUSINESS WIRE)--Sydnexis, Inc. (www.sydnexis.com), a pre-commercial stage biopharmaceutical company, today 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., Ltd., a Japan-based company specialized in eye health, offering innovative products and services in over 60 countries worldwide.

“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, Chief Executive Officer of Sydnexis. “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 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.

“Santen recognized early on that SYD-101’s novel, proprietary formulation was unique in its ability to deliver superior drug activity, maximum stability, and optimal comfort,” said Patrick Johnson, Ph.D., President of Sydnexis. “They have been a great partner, and we are excited for Santen to bring SYD-101 to market across multiple continents.”

Myopia 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.

“I am thrilled about the progress to bring SYD-101 to market for the millions of pediatric patients impacted by this growing epidemic,” said Professor Mark Bullimore, OD, Ph.D. “The news of CHMP’s positive opinion should have a huge impact in Europe, where low-dose atropine has been largely unavailable.”

About Sydnexis, Inc.:

Founded in 2014, Sydnexis, Inc. (www.sydnexis.com) is a privately held, pre-commercial stage biopharmaceutical company based in San Diego, California. Sydnexis recently completed its three-year primary endpoint in the pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow progression of pediatric myopia and the risk of associated co-morbidities. The Phase 3 clinical trial is now completing the fourth-year randomized withdrawal for exploratory endpoints and third year results will be announced upon completion of the fourth year of the study. The company is venture-backed by four major investors: Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital.