FDA Accepts Sydnexis NDA for SYD-101

Sydnexis has reached a significant regulatory milestone with the FDA’s acceptance of its New Drug Application (NDA) for SYD-101, a potential first-in-class pharmaceutical treatment for the progression of pediatric myopia in the United States.

FDA Sets Target Review Date for SYD-101

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025, signaling the timeline for the agency’s review of the application. If approved, SYD-101 would become the first and only FDA-approved pharmaceutical treatment for pediatric myopia progression, addressing a critical unmet need in ophthalmology.

Sydnexis Leadership on This Milestone

Perry Sternberg, Chief Executive Officer of Sydnexis, emphasized the importance of the FDA’s acceptance in a company news release:

“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. 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.”

Clinical Evidence Supporting the NDA

The NDA submission is supported by data from the STAR Study, a Phase 3 clinical trial evaluating Sydnexis’ proprietary low-dose atropine formulation for slowing pediatric myopia progression and reducing the risk of associated ocular complications.

Patrick Johnson, PhD, President at Sydnexis, highlighted the significance of the study and SYD-101’s unique formulation:

“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.”

The Growing Burden of Pediatric Myopia

Myopia is the most common eye disease among children, currently affecting approximately 28 million children in the U.S.. Due to lifestyle and environmental factors, both the prevalence and severity of myopia are expected to rise, underscoring the need for effective pharmaceutical interventions to slow its progression and reduce long-term complications.

Conclusion

The FDA’s acceptance of the NDA for SYD-101 represents a pivotal moment for the future of pediatric myopia management. With the largest clinical study ever conducted in this field supporting its application, SYD-101 has the potential to transform the standard of care and provide millions of children with a safe, once-daily treatment option. Pending FDA review, SYD-101 could mark a new era in pediatric eye health.