September 24, 2026
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DEL MAR, Calif. — Sydnexis, Inc., announced that the U.S. Food and Drug Administration (FDA) has scheduled an Advisory Committee meeting, including an Open Public Hearing, to review the New Drug Application (NDA) for SYD-101. The review is scheduled for October 30, 2026.
SYD-101 is currently approved in the European Union and UK, where it is licensed to Santen S.A. and marketed as Ryjunea.
“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
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 −0.75D at Month 36. This threshold was 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.
“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,” Sternberg said. “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 Benefits of An Approved Atropine Therapy
“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 pediatric progressive myopia, 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 Public Hearing
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.
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