US advisers questioned the 0.01% atropine drop: what it means for a child already on drops
On 30 October 2026 a US advisory committee questioned a 0.01% atropine drop for children's short-sightedness. Here is what the panel said, what it did not decide, and why a child already on drops should not change anything without the eye doctor.
- On 30 October 2026 an FDA advisory committee gave advice on a 0.01% atropine drop (code SYD-101) for children's short-sightedness. Its advice does not bind the FDA, and no FDA decision had been announced by 6 November 2026.
- Reports say panel members questioned a borderline main result, missing data, no significant effect on eye length, and no effect in 12 to 14 year olds.
- The doubts are about whether one company's trial is strong enough for a US approval. They are not a finding that low-dose atropine does not work, and the drop is already approved in the EU and the UK.
- The concerns echo what this site already sets out: a modest, less consistent effect at the lowest dose, and very low certainty in the Cochrane review.
- If your child is already on atropine drops, talk to your child's eye doctor before changing anything. Do not stop, skip or switch because of a news story.
On 30 October 2026 an advisory committee of the United States Food and Drug Administration (FDA) met to look at a 0.01% atropine eye drop for children's short-sightedness, and the reports that followed describe a doubtful room.
If your child already uses low-dose atropine, or you were about to start, the headlines can sound as if the drops have been judged not to work. That is not what happened. The short version: the panel gave advice on one company's application, the FDA has not announced a decision, and nothing in this news tells you to change what your child is doing.
This page is the news and what it changes for a Malaysian family. The trial evidence itself is on the pages that came before it, and I link them below instead of repeating them.
What did the US advisers actually decide?
Nothing, in the sense of approving or refusing a drug. The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee gave advice on an application from the company Sydnexis for a 0.01% atropine drop, known by the code SYD-101. The committee's advice does not bind the FDA, which makes its own decision. By 6 November 2026 no FDA decision had been announced, and the company says it will keep talking to the agency.
The background matters. Healio reports that the FDA declined to approve the drop in October 2025, and that the company then asked for a formal review of that refusal before this meeting was called. The same drop is already approved in the European Union and the United Kingdom, according to Ophthalmology Times. Healio does not report a committee vote. A trade report read the room as pointing towards a new trial being needed, but that is the reporter's impression, not a recorded vote.
What exactly did the panel question?
Four things, as the trade press reports them. Please read them as reports of a discussion, not as a verdict on the drug.
First, the main result of the company's phase 3 trial, called STAR, was borderline. The company says the trial met its pre-set main and key secondary targets, and the Review of Myopia Management reports that panel members agreed the pre-set threshold was met. What worried them was how robust that result was for a single trial, given missing data: small changes in how the gaps are handled could erase the effect. Healio adds that FDA reviewers had judged the overall results to show limited to no clinical benefit.
Second, eye length. The lengthening of the eye is what drives the rising prescription, and the trial did not show a significant effect on it, which made members hesitant. They advised that future myopia trials should measure eye length in a standard way.
Third, how long the effect lasts. Some members said what the trial shows may reflect a "transient delay" rather than a lasting change in the disease, because the effect on the prescription faded over time.
Fourth, age. The panel noted a biological reason younger children might benefit more, but the effect in 12 to 14 year olds was essentially none. The age and fast-progressor analyses were exploratory, and the groups of the youngest children were small, so they could not prove the drop works in a chosen group.
The other side was heard too. Nineteen speakers at the public hearing supported approval, including optometrists and ophthalmologists, and the company pointed to nearly 60 written comments sent to the FDA.
Does this mean low-dose atropine does not work?
No. The question in front of the panel was narrower: whether one company's trial was strong enough to carry a United States approval of one 0.01% product. That is a different question from whether atropine can slow short-sightedness in a growing child. The Review of Myopia Management reports the panel's view that the wider published literature shows an overall biological signal, but is too varied in design, quality and age of children to confirm the result without a second independent trial.
That fits what trials on this site already show. In the LAMP trial of 438 children, the prescription changed by -0.81 D over a year with a dummy drop and by -0.59 D with 0.01% atropine, while the stronger 0.05% drop gave -0.27 D, all set out in does low-dose atropine work for myopia in children in Malaysia.
A real effect, and a modest one at the lowest dose. The panel's doubts are real and they are about that lowest dose. They are not a finding that the treatment is useless.
How does this sit beside the trials already on this site?
It has the same shape as uncertainty already set out. In the CHAMP trial the main target for 0.02% atropine was missed, while 0.01% did slow the prescription as a secondary result. A European trial found the benefit on prescription only in its White children, not its non-White children. The 2025 Cochrane review finds a small average effect for doses below 0.1% and rates the certainty as very low. All of that is in atropine drops for myopia: what the numbers say.
What the panel adds is a regulator's reading: on one trial, the result may not be robust enough for approval. What it does not add is any new trial data, and it contains nothing on Malaysian children. A local trial, ATOM-MY, is recruiting children aged 5 to 10 and has no results yet, as noted in the page linked above.
My child is already on atropine drops. What should we do?
Keep to the plan your child's eye doctor set, and ask about this at the next review. Please talk to your child's eye doctor before changing anything, whether that means stopping, skipping nights or switching to another strength. Stopping is not free: in trials, eyes progressed faster again after treatment ended, which is why a stop is planned with the doctor, as explained in when can we stop myopia treatment.
It also helps to know the news is about 0.01%. Your child may be on a different strength, and the right strength is a decision made for that child. Some questions worth bringing to the appointment:
- Which strength is my child on, and why that one?
- How are we measuring progress, by the prescription alone or by eye length as well?
- What would make you change the plan, and when is the next review?
The first review and the checks that follow are described in low-dose atropine for myopia: the first month.
Does a US decision change what is available in Malaysia?
The FDA regulates medicines sold in the United States. A decision there would not by itself decide what a Malaysian eye doctor can prescribe, and this meeting has not changed that. Atropine for myopia control is a prescription medicine, and what is registered and obtainable where you live is a question for your child's own eye doctor. The side effects and what shapes the cost are in atropine eye drops for myopia: side effects and what decides the cost.
Two practical points. Headlines about a drug being doubted can attract sellers of drops that promise to cure short-sightedness, and the checks on those are in eye drops that cure short-sightedness. And the next step is the FDA's, not yours: it may decide, or ask for more evidence, and this page does not guess which. When there is a decision, it will be a news item again, and the sensible answer will still be the same one: your child's own measurements, read by your child's own eye doctor.
- A child using atropine drops or any eye drops develops a red, painful or persistently light-sensitive eye, or a rash around the eye.
- Your child's prescription has jumped sharply in under a year, or one eye is much more short-sighted than the other.
- An eye starts to turn in or out, having been straight before.
- A strongly short-sighted child reports new floaters, flashes of light, or a shadow or curtain across part of the vision.
Common questions
Did the FDA reject the 0.01% atropine drop on 30 October 2026?
Does this mean low-dose atropine does not work for myopia?
My child is on atropine drops. Should we stop?
What did the panel say about children aged 12 to 14?
Why do people say the effect may be a 'transient delay'?
Is the 0.01% drop approved anywhere?
Does the FDA decision change what is available in Malaysia?
the reference pages Myopia control in Malaysia →
- Healio 2026 · FDA committee considers SYD-101 for pediatric myopia (30 October 2026) · www.healio.com (opens in a new tab)
- Review of Myopia Management 2026 · FDA panel casts doubt on Sydnexis myopia drug: is a new trial inevitable? (2 November 2026) · reviewofmm.com (opens in a new tab)
- Ophthalmology Times 2026 · FAQ: SYD-101 heads to FDA advisory committee, what clinicians should know (13 October 2026) · www.ophthalmologytimes.com (opens in a new tab)
- Ophthalmology 2019 · Low-Concentration Atropine for Myopia Progression (LAMP) Study, phase 1 randomised placebo-controlled trial (Yam et al.) · pubmed.ncbi.nlm.nih.gov (opens in a new tab)
- JAMA Ophthalmology 2023 · Efficacy and Safety of 0.01% and 0.02% Atropine for Pediatric Myopia Progression Over 3 Years (CHAMP) · pubmed.ncbi.nlm.nih.gov (opens in a new tab)
- Cochrane Database of Systematic Reviews 2025 · Interventions for myopia control in children: a living systematic review and network meta-analysis · pubmed.ncbi.nlm.nih.gov (opens in a new tab)
- ClinicalTrials.gov · ATOM-MY, 0.025% atropine versus placebo in children aged 5 to 10 in Malaysia (NCT07329777) · clinicaltrials.gov (opens in a new tab)