FDA accepts new drug application for low-dose atropine from Sydnexis

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The FDA has accepted the New Drug Application (NDA) submitted by Sydnexis for SYD-101, a low-dose atropine drop indicated for myopia management, with a Prescription Drug User Fee Act (PDUFA) target action date set for October 23, 2025. If approved, the atropine drop will be the first and only pharmaceutical option for the treatment of progression of 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,” Perry Sternberg, Chief Executive Officer of Sydnexis, said in a press 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 STAR study, a phase 3 clinical trial evaluating SYD-101’s proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated comorbidities, provided the foundation of Sydnexis’s NDA filing. The 3-year study enrolled 852 patients.

“SYD-101’s novel, proprietary formulation was uniquely designed to deliver superior drug activity, maximum stability, and optimal comfort,” Patrick Johnson, PhD, President at Sydnexis, said in a press release. “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 a growing issue across the globe and is expected to affect 50% of the world population by 2025. Myopia is also linked to serious visual comorbidities that may develop later in life. Increased urgency to slow the progression of myopia has led to innovative solutions, such as contact lenses, spectacles, off-label atropine use, and lifestyle changes. While only contact lenses (MiSight, CooperVision) are currently approved by the FDA, the NDA acceptance of SYD-101 following the agency’s decision to grant Breakthrough Device Designation for SightGlass Vision’s Diffusion Optics Technology (DOT) spectacle lenses, shows that the FDA is taking the public health concern seriously. The increase in FDA-approved options to slow the progression of myopia also empowers eye care providers to choose the best option for their patient. It also encourages additional investigation into combination therapy.

“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,” Paul Karpecki, OD, FAAO, Director of Cornea and Advanced Ocular Surface Disease at Kentucky Eye Institute in Lexington, Kentucky, said in a press release.

To learn more about SYD-101’s formulation, visit the Sydnexis website.