- FDA assigns a PDUFA target action date of October 23, 2025
- If approved, SYD-101 would be the first and only pharmaceutical treatment option proven to slow the progression of pediatric myopia
Sydnexis, Inc. (www.sydnexis.com), a pre-commercial stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would 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,” said Perry Sternberg, Chief Executive Officer 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 based on three-year primary and secondary endpoints from the STAR Study, Sydnexis’ pivotal 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, Ph.D., 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.”
“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,” said Dr. Gregory Ostrow, M.D., Director of Pediatric Ophthalmology and Adult Strabismus at Scripps Clinic in San Diego, CA.
Myopia is the most common eye disease in children, impacting approximately 28 million children in the U.S. alone with prevalence and severity expected to continue climbing due to lifestyle and environmental factors. Once considered a benign refractive condition, even at low levels, myopia is now associated with many serious irreversible sight-threatening co-morbidities later in life.
“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,” said Dr. Paul Karpecki, OD, FAAO, Director of Cornea and Advanced Ocular Surface Disease at Kentucky Eye Institute in Lexington, KY.
About Sydnexis, Inc.:
Founded in 2014, Sydnexis, Inc. (www.sydnexis.com) is a privately held, pre-commercial stage biopharmaceutical company based in San Diego, California. Sydnexis recently completed its three-year primary endpoint in the pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow progression of pediatric myopia and the risk of associated co-morbidities. The Phase 3 clinical trial is now completing the fourth-year randomized withdrawal for exploratory endpoints and third year results will be announced upon completion of the fourth year of the study. The company is venture-backed by four major investors: RA Capital, Longitude Capital, Visionary Ventures, and Bluestem Capital.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250311482503/en/
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