June 6, 2025
Photo Credit: Getty Images
DEL MAR, Calif. — Sydnexis‘ proprietary low-dose atropine formulation, SYD-101, has received marketing authorization from the European Commission (EC). SYD-101 is the first and only approved pharmaceutical treatment option to treat myopia progression in EU countries.
The approval is backed by data from the STAR study, Sydnexis’ pivotal Phase 3 clinical trial. The study evaluated the proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated co-morbidities in children 3 to 14 years old at treatment initiation.
“This marks a significant milestone for Sydnexis and, most importantly, for pediatric patients with progressive myopia, their families, and physicians as the first and only approved pharmaceutical treatment option in Europe,” said Perry Sternberg, Chief Executive Officer of Sydnexis. “This approval is an endorsement of the potential benefit SYD-101 can provide to millions of patients globally and reinforces the critical importance of early intervention.”
Positive Opinion in Europe
The marketing approval from the EC follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Santen, a Japan-based company specialized in eye health, licensed the rights from Sydnexis to commercialize SYD-101 in Europe, the Middle East, and Africa (EMEA). SYD-101 will be licensed under the brand name Ryjunea.
“The EU approval of SYD-101 is a recognition of the compelling safety and efficacy data generated from our landmark STAR study,” said Patrick Johnson, PhD, President of Sydnexis. “This validates the potential benefit that SYD-101 can provide to pediatric myopes in Europe and we are excited about our continued interactions with the Food and Drug Administration (FDA) leading up to our October 23 PDUFA date.”
“As a Pediatric Ophthalmologist with a rapidly growing number of myopia patients around the world, the EU approval of SYD-101 is truly exciting and it provides an important new tool for physicians to combat this global epidemic,” said Dr. Donny Suh, Gavin Herbert Eye Institute, University of California at Irvine. “The benefits of low-dose atropine have long been recognized in the eye care community, but we now finally have an approved and thoroughly vetted treatment option. This marks a new era in our ability to slow the progression of myopia and protect the vision of millions of children worldwide.”
