Key Takeaways

  • The FDA has scheduled an October 30, 2026, advisory committee meeting to review Sydnexis’ NDA for SYD-101 for pediatric progressive myopia
  • In the 847-patient phase 3 STAR trial, SYD-101 0.01% met its prespecified primary endpoint and key secondary endpoint and was reported to be well tolerated through month 48
  • The meeting will include an Open Public Hearing allowing physicians, caregivers, and other members of the public to provide perspectives to the FDA advisory committee

The FDA has scheduled an advisory committee meeting for October 30, 2026, to review the new drug application (NDA) for Sydnexis’ SYD-101, a low-dose atropine formulation being developed to treat pediatric progressive myopia (PPM). The committee meeting comes almost a year after the FDA issued a complete response letter (CRL) for Sydnexis' NDA for SYD-101 in October 2025. 

According to Sydnexis, the upcoming FDA meeting will include an Open Public Hearing, providing physicians, caregivers, and other members of the public an opportunity to share their perspectives with the advisory committee.

SYD-101 is a proprietary low-dose atropine formulation designed to slow the progression of myopia in children. The treatment is already approved in the European Union and United Kingdom, where it is licensed to Santen and marketed as Ryjunea.

The NDA is supported by results from the phase 3 STAR trial, a global, randomized, vehicle-controlled study that evaluated SYD-101 in 847 children aged 3 to 14 years in the United States and Europe.

The study's prespecified primary endpoint assessed whether treatment reduced the proportion of children experiencing confirmed myopia progression beyond −0.75 D at month 36. According to Sydnexis, the threshold had previously been identified as clinically meaningful by the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee in 2003 and was subsequently agreed upon with the agency for use in STAR.

Annual myopia progression rate served as the study's key secondary endpoint.

Sydnexis reported that SYD-101 0.01% met the trial's primary endpoint (P=.0226) and key secondary endpoint (P=.0002). The company also reported that the treatment 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,” Perry Sternberg, CEO of Sydnexis, said in a statement.

Mr. Sternberg noted that the STAR trial met both its prespecified primary and key secondary endpoints and said the findings should be considered in the context of a progressive condition in which treatment is intended to limit the accumulation of irreversible myopia during childhood.

Low-dose atropine is already used in US clinical practice for myopia management, although there is currently no FDA-approved pharmaceutical treatment available for the indication, according to Sydnexis.

During the Open Public Hearing, physicians and caregivers will be able to provide firsthand perspectives to the committee. Sydnexis said it plans to release additional information about meeting logistics, including procedures for attending the meeting or submitting comments, as those details become available.