Advisory Committee Meeting and Public Hearing Set for October 30, 2026
DEL MAR, Calif.--(BUSINESS WIRE)--Sydnexis, Inc., a clinical-stage pharmaceutical company developing SYD-101, a novel low-dose atropine formulation for the treatment of pediatric progressive myopia (PPM), today announced that the U.S. Food and Drug Administration (FDA) has scheduled an Advisory Committee meeting, including an Open Public Hearing, for October 30, 2026, to review the New Drug Application (NDA) for SYD-101. SYD-101 is currently approved in the European Union and UK, where it is licensed to Santen S.A. and marketed as Ryjunea®.
The Phase 3 STAR trial was a large, global, randomized, vehicle-controlled study evaluating SYD-101 in 847 children aged 3–14 across the U.S. and Europe. Its prespecified primary endpoint evaluated whether treatment reduced the proportion of children experiencing confirmed progression beyond −0.75 D at Month 36, a threshold identified as clinically meaningful by the 2003 FDA Dermatologic and Ophthalmic Drugs Advisory Committee and subsequently agreed with FDA for use in STAR. Annual myopia progression rate was the key secondary endpoint. SYD-101 0.01% met both the primary endpoint (p=0.0226) and key secondary endpoint (p=0.0002) and was well tolerated, with no new safety signals identified through Month 48.
“We welcome the opportunity for a thorough, science-based discussion on SYD-101 and the totality of evidence supporting its use in pediatric progressive myopia,” said Perry Sternberg, Chief Executive Officer of Sydnexis. “The STAR trial met its prespecified primary and key secondary endpoints, and those results should be considered within the broader clinical context of a progressive disease in which the goal of treatment is to prevent irreversible myopia from accumulating during childhood. We look forward to discussing the data alongside the extensive evidence supporting low-dose atropine and the clinical experience of physicians who treat children every day.”
“The goal for clinicians who treat PPM is to intervene and slow progression during the years when a child’s eyes are still developing, as this limited time period is when myopia is most active,” said Rahul Bhola, MD, Medical Director and Chief, Division of Ophthalmology at Children’s Hospital of Orange County. “Low-dose atropine is already used routinely by many pediatric ophthalmologists and optometrists as part of standard clinical practice, but an FDA-approved treatment would give physicians a standardized, rigorously evaluated option. Beyond changing the underlying course of PPM, an approved therapy would also help address the access and consistency challenges often associated with compounded formulations, which is the only option available today in the U.S. I look forward to participating in this advisory committee meeting, where the strength of the STAR trial data can be discussed and real-world clinical perspectives can be heard.”
The Open Public Hearing portion of the meeting will give physicians and caregivers the opportunity to share their firsthand experience directly with the advisory committee. Sydnexis will provide further details on the meeting logistics, including how members of the public may register to attend or submit comments, as they become available.
About Pediatric Progressive Myopia (PPM)
Pediatric Progressive Myopia (PPM) is the most common eye disease in children and a rapidly rising global health concern. Nearly one-third of children worldwide are already affected by this degenerative disease, with prevalence projected to exceed 740 million cases by 2050 (Liang et al., 2024). In North America, myopia prevalence is expected to reach nearly 60% by 2050, according to a landmark study published in Ophthalmology (Holden et al., 2016). The most rapid progression of the disease occurs in children ages 3 to 10 years (Hu et al., 2020), with patients who start progressing younger experiencing more severe outcomes and associated co-morbidities, including cataracts, glaucoma, retinal detachment, and myopic maculopathy. Despite its growing prevalence, there are currently no FDA-approved pharmaceutical options in the United States to slow the progression of PPM, representing a significant gap in available treatment options for patients.
About Sydnexis, Inc.
Sydnexis, Inc. is a biopharmaceutical company dedicated to advancing care for pediatric progressive myopia. The company’s lead compound, SYD-101, is currently approved in the European Union and UK, where it is licensed to Santen S.A. and marketed as Ryjunea®. Sydnexis is supported by leading life-science investors, including Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital. For more information on Sydnexis, please visit www.sydnexis.com.
Contacts
Media contact:
FTI Consulting
Robert Stanislaro or Helen O’Gorman
sydnexis@fticonsulting.com
