Sydnexis announced that the US Food and Drug Administration (FDA) has scheduled an advisory committee meeting for October 30 to review the New Drug Application (NDA) for SYD-101, the company’s investigational low-dose atropine formulation for pediatric progressive myopia. The meeting will include an open public hearing, during which physicians and caregivers will have an opportunity to provide comments to the advisory committee, according to the company.

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 trial’s prespecified primary endpoint assessed whether treatment reduced the proportion of children with confirmed myopia progression beyond -0.75 D at month 36. Annual myopia progression rate was the key secondary endpoint.

According to Sydnexis, SYD-101 0.01% met the primary endpoint (P=.0226) and key secondary endpoint (P=.0002). The company reported that the treatment was well tolerated, with no new safety signals identified through month 48. SYD-101 is already approved in the European Union and United Kingdom, where it is licensed to Santen S.A. and marketed as Ryjunea.

Sydnexis CEO Perry Sternberg said the company plans to discuss the STAR trial findings and the broader evidence supporting low-dose atropine use in pediatric progressive myopia during the meeting. Rahul Bhola, MD, medical director and chief of the division of ophthalmology at the Children’s Hospital of Orange County, noted in the announcement that low-dose atropine is currently used by pediatric ophthalmologists and optometrists in clinical practice but is available in the United States through compounded formulations rather than as an FDA-approved treatment. Sydnexis said it will provide additional information about the meeting, including details for attending or submitting public comments, as they become available.