FDA accepts NDA for SYD-101 to treat pediatric myopia

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Sydnexis has announced that the FDA has accepted its new drug application (NDA) for SYD-101. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would become the first pharmaceutical treatment for the progression of pediatric myopia in the United States, according to the company.

“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, CEO 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 supported by results from the STAR Study, a pivotal Phase 3 clinical trial conducted by Sydnexis. The study evaluated the efficacy and safety of SYD-101, a low-dose atropine formulation, over three years. The STAR Study enrolled more than 850 patients aged 3 to 14 years, making it the largest clinical study ever completed for the treatment of pediatric myopia progression.

“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.”

Gregory Ostrow, MD, director of pediatric ophthalmology and Adult Strabismus at Scripps Clinic in San Diego, California, highlighted the potential significance of the treatment. “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,” he said.

Myopia is the most common eye disease in children, affecting approximately 28 million children in the United States alone. Its prevalence and severity are expected to increase due to lifestyle and environmental factors. Even at low levels, myopia is associated with serious, irreversible, sight-threatening co-morbidities later in life.

“We are excited about SYD-101 as a potential treatment option for our pediatric population,” said Paul Karpecki, OD, FAAO, director of cornea and advanced ocular surface disease at Kentucky Eye Institute in Lexington, Kentucky. “Having [the] first FDA-approved product that we can offer early in our patients’ myopia progression is needed.”

Reference:

Sydnexis. Sydnexis Announces FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia. businesswire. March 11, 2025. Accessed March 11, 2025. https://www.businesswire.com/news/home/20250311482503/en/Sydnexis-Announces-FDA-Acceptance-of-New-Drug-Application-for-SYD-101-for-the-Treatment-of-Progression-of-Pediatric-Myopia