Sydnexis announced that the FDA has accepted its new drug application (NDA) for SYD-101, which if approved would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025.

“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,” Perry Sternberg, Chief Executive Officer of Sydnexis, said in a company news release. “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 3-year primary and secondary endpoints from the STAR Study, Sydnexis’ 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.”

Myopia is the most common eye disease in children, impacting approximately 28 million children in the US with prevalence and severity expected to continue climbing due to lifestyle and environmental factors.

Link to press release: https://eyewire.news/news/sydnexis-announces-fda-acceptance-of-nda-for-syd-101-for-the-treatment-of-progression-of-pediatric-myopia?c4src=article:infinite-scroll