The low-dose atropine formulation could be the first approved drug in the United States to slow myopia in children.
On March 11, 2025, Sydnexis Inc. (California, USA) announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-101 (low-dose atropine sulfate ophthalmic solution), an investigational treatment aimed at slowing the progression of pediatric myopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025.
Sydnexis announces the news on its LinkedIn page.
If approved, SYD-101 would become the first FDA-approved pharmaceutical treatment option for pediatric myopia progression 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, in a news release.
A closer look at SYD-101
SYD-101 is a low-dose atropine sulfate ophthalmic solution designed for safety and tolerability. The treatment involves applying a single drop in each eye nightly.
Clinical evidence supports application
The NDA submission is backed by three-year data from the STAR study, a Phase III clinical trial evaluating SYD-101’s effectiveness in slowing the progression of myopia and reducing the risk of associated co-morbidities.
The STAR study, which enrolled more than 850 children aged 3 to 14 years, is reported to be the largest clinical trial ever conducted for pediatric myopia treatment to date.
“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.
The trial is currently in its fourth year, completing a randomized withdrawal phase to explore additional endpoints. Third-year results will be announced once this phase is complete.
Support from the eye care community
Eye care specialists have responded positively to the potential availability of an FDA-approved treatment for pediatric myopia.
Dr. Gregory Ostrow, director of Pediatric Ophthalmology and Adult Strabismus at Scripps Clinic (California, USA), stated, “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.”
Dr. Paul Karpecki, director of Cornea and Advanced Ocular Surface Disease at Kentucky Eye Institute (USA), added, “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.”
With growing clinical evidence and support from the medical community, the FDA’s decision on SYD-101 will be closely watched in the coming months.