March 11, 2025
Photo Credit: Dreamstime Photos
DEL MAR, Calif. — The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for Sydnexis’ SYD-101 for myopia management. The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States.
“The FDA acceptance of our NDA filing for SYD-101 marks a critical step forward for Sydnexis in bringing an innovative treatment option to the millions of pediatric patients with progressive myopia,” said Perry Sternberg, Chief Executive Officer of Sydnexis. “I’m incredibly proud of our talented team for reaching this milestone and look forward to collaborating with the FDA to bring a once-daily, safe and effective eye drop to pediatric myopia patients, their families, and clinicians.”
The NDA application is based on three-year primary and secondary endpoints 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.
“SYD-101’s novel, proprietary formulation was uniquely designed to deliver superior drug activity, maximum stability, and optimal comfort,” said Patrick Johnson, PhD, President at Sydnexis. “We knew we wanted to evaluate SYD-101 in a very robust study. Our landmark STAR Study is the largest clinical study ever completed for the treatment of progression of pediatric myopia, enrolling more than 850 patients across a broad patient population of 3- to 14-year-olds.”
“Having the ability to offer a safe and effective FDA-approved treatment for my pediatric myopic patients would be a welcomed and critical step forward in addressing this global epidemic as so few options are available,” said Dr. Gregory Ostrow, MD, Director of Pediatric Ophthalmology and Adult Strabismus at Scripps Clinic in San Diego, CA.
