EMA grants positive CHMP opinion for low-dose atropine SYD-101 (Ryjunea, Sydnexis)
A pivotal phase 3 clinical trial found that SYD-101 met its 3-year primary endpoint for slowing paediatric myopia progression
The US FDA recently assigned SYD-101 a PDUFA date of October 23, 2025. Image credit: ©Lubo Ivanko – stock.adobe.com
California-based biopharmaceutical company Sydnexis, Inc. announced that the European Medicines Agency (EMA) and its Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the company’s candidate for slowing progression of paediatric myopia. The CHMP issued its positive opinion for SYD-101, a proprietary low-dose atropine formulation, shortly after an update from the United States Food and Drug Administration (FDA) which assigned SYD-101 a Prescription Drug User Fee Act (PDUFA) date.
The CHMP positive opinion was supported by data from the pivotal Phase 3 clinical trial, the STAR study, evaluating SYD-101 as a therapeutic for slowing the progression of paediatric myopia. The trial also assessed the risk of associated comorbidities. SYD-101 successfully reached its 3-year primary endpoint in the trial, demonstrating efficacy in slowing the annual progression rate of myopia in paediatric patients ages 3 to 14 years old at 24 months. The trial is now completing randomised withdrawal for exploratory endpoints ahead of its fourth year. According to the press release, third-year results will be announced upon completion of the fourth year of the study.
Santen SA will serve as the commercialisation partner for SYD-101 in the regions of Europe, the Middle East, and Africa (EMEA). Santen will commercialise SYD-101 under the brand name Ryjunea in the EMEA.
Professor Mark Bullimore, OD, PhD, commented on the approval in the press release. “I am thrilled about the progress to bring SYD-101 to market for the millions of pediatric 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,” he said.
“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.”
Patrick Johnson, PhD, President of Sydnexis, utilised the press release to give special acknowledgement to Santen for the company’s partnership. “Santen recognised early on that SYD-101’s novel, proprietary formulation was unique in its ability to deliver superior drug activity, maximum stability, and optimal comfort…We are excited for Santen to bring SYD-101 to market across multiple continents.”
