FDA advisory committee reviews SYD-101 atropine eye drops for pediatric myopia

An FDA advisory committee met on October 30, 2026 to evaluate Sydnexis's SYD-101 (atropine 0.01%) for slowing pediatric myopia following an October 2025 approval rejection. While SYD-101 achieved its Phase 3 primary endpoint, the FDA questioned the trial's statistical robustness and clinical efficacy. Conversely, eye care specialists and medical societies strongly advocated for approval during public testimony, citing the need for a standardized, insurance-covered product over unstandardized compounding pharmacy formulations.

Advisory committee meeting on Sydnexis dispute

• ▪Sydnexis submitted a formal dispute resolution request after receiving a complete response letter from the FDA in October 2025 declining to approve SYD-101.
• ▪The FDA advisory committee convened to review SYD-101, a low-dose atropine 0.01% eye drop developed by Sydnexis for slowing pediatric myopia
• ▪During the October 30, 2026 meeting, representatives from Sydnexis and two FDA employees each gave hour-long presentations regarding the clinical data for SYD-101.

FDA evaluation of clinical trial results

• ▪FDA advisory committee members evaluated agency concerns regarding the borderline statistical significance of the primary endpoint and clinical meaningfulness of SYD-101's treatment effect.
• ▪Although SYD-101 met its primary endpoint in a phase 3 trial, the FDA determined the overall results suggested limited to no clinical benefit.
• ▪Acting committee chairperson Michael X. Repka stated that while the SYD-101 trial was positive, it lacked the robust outcome required for FDA approval.

Public support for SYD-101 approval

• ▪Nineteen people, including five optometrists and 10 ophthalmologists, spoke in favor of approving SYD-101 during an open public hearing at the advisory committee meeting.
• ▪Sydnexis consultant Robert S. Gold noted that major medical societies overwhelmingly supported FDA approval of SYD-101 during the open public hearing.
• ▪Sydnexis reported receiving support from nearly 60 written public comments submitted to the FDA in favor of SYD-101 approval.
• ▪Paul M. Karpecki, director of cornea and external disease at Kentucky Eye Institute, testified at the FDA hearing that slowing pediatric myopia progression by even 1 diopter provides meaningful clinical benefit.

Arguments for replacing compounded atropine

• ▪Vance Thompson, founder of Vance Thompson Vision, testified that eye doctors currently rely on compounding pharmacies for low-dose atropine, resulting in variable strength, inconsistent products, and lack of insurance coverage.
• ▪Eye care practitioners advocate for FDA approval of SYD-101 to establish a standardized, FDA-regulated atropine product for pediatric myopia treatment to replace compounded alternatives.