The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for SYD-101, a proprietary low-dose atropine eye drop developed by Sydnexis for the management of pediatric myopia progression. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would represent a significant milestone as the first and only pharmaceutical treatment authorized for 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."
Robust Clinical Evidence from Landmark STAR Study
The NDA submission is supported by data from the STAR study, a comprehensive Phase 3 clinical trial that evaluated SYD-101's efficacy and safety in slowing myopia progression and reducing the risk of associated comorbidities. This 3-year study enrolled 852 pediatric patients, making it the largest clinical investigation ever conducted for pediatric myopia progression.
Patrick Johnson, PhD, President at Sydnexis, highlighted the formulation's distinctive properties: "SYD-101's novel, proprietary formulation was uniquely designed to deliver superior drug activity, maximum stability, and optimal comfort. 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."
Addressing a Growing Global Health Concern
Myopia, commonly known as nearsightedness, represents an escalating public health challenge worldwide. Projections indicate that approximately 50% of the global population will be affected by myopia by 2025. Beyond the immediate visual impairment, myopia is associated with serious ocular comorbidities that may develop later in life, including increased risks of retinal detachment, glaucoma, and myopic maculopathy.
The growing prevalence of myopia has spurred development of various interventions to slow its progression, including specialized contact lenses, spectacles, off-label atropine use, and lifestyle modifications. Currently, only MiSight contact lenses (CooperVision) have received FDA approval for myopia control in children.
Expanding Treatment Options for Clinicians
The FDA's acceptance of the SYD-101 NDA follows the agency's recent decision to grant Breakthrough Device Designation for SightGlass Vision's Diffusion Optics Technology (DOT) spectacle lenses, signaling increased regulatory attention to myopia management solutions.
Paul Karpecki, OD, FAAO, Director of Cornea and Advanced Ocular Surface Disease at Kentucky Eye Institute in Lexington, Kentucky, expressed enthusiasm about the potential new treatment option: "We are excited about SYD-101 as a potential treatment option for our pediatric population. Having a first FDA-approved product that we can offer early in our patients' myopia progression is needed."
The expansion of FDA-approved myopia management options would provide eye care professionals with greater flexibility in tailoring treatments to individual patient needs and could potentially facilitate research into combination therapies for enhanced efficacy.
SYD-101's once-daily dosing regimen is designed to offer a convenient treatment option that could improve adherence in the pediatric population. The proprietary formulation aims to balance efficacy in slowing myopia progression with a favorable safety profile and minimal side effects typically associated with higher concentrations of atropine.
As the October 2025 PDUFA date approaches, Sydnexis continues to prepare for potential commercialization while the eye care community awaits what could be a significant addition to the myopia management armamentarium.
