FDA Advisers Meet Oct. 30 on Low-Dose Atropine for Childhood Myopia. The Agency Declined to Approve It Last Year.
An FDA advisory committee meets Oct. 30 on Sydnexis's atropine 0.01% to slow myopia progression in children 3 and older, a year after a complete response letter. Requests to speak are due Oct. 14 and written comments by Oct. 19.
On Oct. 30, the Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee will meet to discuss new drug application 219694, Sydnexis's atropine sulfate ophthalmic solution 0.01%, for "slowing of myopia progression in children 3 years of age or older." The session runs from 8:30 a.m. to 3 p.m. Eastern at the FDA White Oak Campus in Silver Spring, Maryland, and online.
The meeting follows a setback for the drug. Sydnexis announced on Oct. 23, 2025, that the agency had issued a complete response letter for the product, known as SYD-101. Ophthalmology Times reported, citing the company, that the FDA acknowledged the primary endpoint was met but concluded that "the evidence did not demonstrate the effectiveness of low-dose atropine for treating myopia in children." The company said the agency identified no deficiencies in safety or product quality.
What the committee will discuss
The FDA's meeting notice lists the application and the proposed indication. The questions for the committee are not yet public. The agency says it will post background material and the webcast link no later than two business days before the meeting, which is Wednesday, Oct. 28.
A March 2026 Sydnexis release states there are currently no FDA-approved pharmaceutical options in the United States to slow progression. Chief executive Perry Sternberg has described the goal as the first FDA-approved option "rather than continued reliance on compounded formulations of atropine," Ophthalmology Times reported. The European Commission authorized the same product in June 2025; Santen markets it there as Ryjunea.
What the STAR trial showed
The pivotal STAR trial (NCT03918915) randomized 847 children aged 3 to 14 with myopia of -0.50 to -6.00 diopters to vehicle, SYD-101 0.01% or SYD-101 0.03% in a 1:1:1 design, according to a November 2025 Sydnexis release. The primary endpoint, which the company says the FDA proposed, was the proportion of children with confirmed progression of -0.75 diopters at 36 months.
In that release, 49.3 percent of the vehicle group met the progression threshold (95% CI 43.0 to 55.5) versus 39.5 percent on 0.01% (95% CI 33.4 to 45.6; p=0.0226). The 0.03% arm, at 43.1 percent, did not separate from vehicle (p=0.1319). Annual progression was -0.38 diopters for vehicle and -0.30 for 0.01%, a difference of 0.08 diopters a year. Mean spherical equivalent change at 36 months was -0.92 versus -0.71 diopters.
Subgroup data presented at the American Association for Pediatric Ophthalmology and Strabismus meeting, per the March 23 company release, show larger effects in children 3 to 12 at the start: progression was reduced by 47.9 percent at 12 months, 37.6 percent at 24 months and 28.0 percent at 36 months, so the relative effect narrowed over time. In fast progressors with mild to moderate baseline myopia, the reduction at 36 months was 56.9 percent. The company reports no unexpected atropine-related adverse events.
By the company's account, the trial met its primary endpoint and the agency still declined to approve. The open question is how much slowing is enough.
These figures come from the sponsor's releases and conference presentations. The briefing documents should show how the FDA read the subgroup analyses, including whether they were pre-specified, and what its own safety review found.
What the vote does and does not do
Advisory committees give the FDA non-binding advice. A favorable vote would not itself be an approval, and the notice gives no date for an FDA decision. Our earlier piece on how physicians join these committees explains how the panels are staffed.
What practices should do now
The notice sets several deadlines. Requests to speak in the open public hearing, scheduled for roughly 1 to 2 p.m., are due Oct. 14, and the FDA will notify speakers by Oct. 15. Written comments to docket FDA-2026-N-10606 go to the committee if received by Oct. 19. The docket closes at 11:59 p.m. Eastern on Oct. 29. Comments are posted publicly, so they should not include patient information.
Clinicians who prescribe compounded low-dose atropine should not expect the meeting itself to change what is available. When the briefing documents post, read the FDA's assessment of the primary endpoint, the subgroup claims and durability before taking a view on the vote.
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
