Sydnexis Announces FDA Acceptance of New Drug Application for SYD-101 for the Treatment of
Progression of Pediatric Myopia
• 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
DEL MAR, Calif. - March 11, 2025 – 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.
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