Sydnexis Announces European Commission Approval of SYD-101, the First and Only Pharmaceutical Treatment for Slowing the Progression of Pediatric Myopia

Business Wire

a day ago

DEL MAR, Calif.--(BUSINESS WIRE)--Sydnexis, Inc., (www.sydnexis.com) a pre-commercial stage biopharmaceutical company today announced that the European Commission (EC) has granted marketing authorization for SYD-101, the company's proprietary low-dose atropine formulation, for slowing the progression of pediatric myopia. As the first and only approved pharmaceutical treatment option to treat myopia progression in EU countries, this approval marks a significant advancement in pediatric eye care. The approval is backed 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 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.'
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, offering innovative products and services in over 60 countries worldwide, licensed the rights from Sydnexis to commercialize SYD-101 in the regions of Europe, Middle East, and Africa (EMEA) and will launch SYD-101 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, Ph.D., 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.'
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.
'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.'
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.