April 2, 2025
Photo Credit: Getty Images
DEL MAR, Calif. — Sydnexis has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its low-dose atropine formulation, SYD-101.
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, PhD, President of Sydnexis. “They have been a great partner, and we are excited for Santen to bring SYD-101 to market across multiple continents.”
“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, PhD. “The news of CHMP’s positive opinion should have a huge impact in Europe, where low-dose atropine has been largely unavailable.”
