Justin Cooper; Robert S. Gold, MD; Cheryl Chapman, OD, FIAOMC, FAAO, Dipl ABO
2026-01-28 22:18:00
January 28, 2026
5 min read
Key takeaways:
- More than 800 people have signed a petition urging the FDA to approve low-dose atropine to slow pediatric myopia.
- The FDA decided not to approve a formulation in October.
A Change.org petition with more than 800 signatures is calling on the FDA to approve low-dose atropine to slow the progression of pediatric myopia.
It comes after the FDA decided not to approve SYD-101 (0.01% atropine, Sydnexis) in October despite acknowledging the drug met its primary efficacy endpoint in a phase 3 study and had no safety or quality issues.
The petition was posted on Dec. 9 by the Pediatric Progressive Myopia Coalition, a partnership between Robert S. Gold, MD, FAAP, a pediatric ophthalmologist at Eye Physicians of Central Florida, and Cheryl Chapman, OD, FIAOMC, FAAO, Dipl ABO, owner of Gretna Eye & Aesthetics and past president of the American Academy of Orthokeratology and Myopia Control. At the time of writing, it has 817 signatures.
Compounded atropine is currently available for patients who can pay out of pocket, but an FDA-approved formulation would help avoid issues with stability, consistency and accessibility, Gold and Chapman told Healio.
“We were fully expecting the low-dose atropine from Sydnexis to be approved in October 2025,” Chapman said in an interview. “When it wasn’t, it really riled us all up and got us thinking, ‘Hey, what can we do to help raise awareness?’”
In the meantime, myopia continues to progress in children without access to other types of treatments, potentially leading to further visual problems, Gold said.
“This is a disease. This is not a benign situation,” Gold said. “This disease can cause major visual problems — things like glaucoma, cataracts, retinal detachments. We’re trying to slow down that progression and those risks. This is why we are so passionate about this type of medication.”
Healio spoke with Gold and Chapman to learn more about their petition.
Healio: What was the motivation for this petition?
Chapman: The goal was to show how many doctors are really paying attention to this. They are subject matter experts, and they support this drop because we understand that it works and that it is important.
I know that the FDA is there for a reason, and I know that the FDA is important in making sure that anything that enters our system is safe. But we are disappointed because Sydnexis met all the safety, efficacy, and primary and secondary endpoints, so it feels like the goal posts were moved when the drug was not approved. We feel like the FDA’s reasoning was not sound.
Traditionally, optometrists and ophthalmologists are often focused on different areas, but we feel so strongly about it that we came together and worked on this petition to raise awareness about how important it is from the clinician’s perspective. The clinician’s perspective is different from somebody who works at the FDA, who I would consider a little bit more of a lay person when it comes to eyes in general. We know eyes more than anybody else. We are heavily trained in eyes, we know what works, and we are all using atropine, so for us to have access to a drop that is commercially prepared, with a more consistent formula and manufacturing process, is important.
Gold: The bottom line is that all endpoints were met, except for the endpoint of approval. This has been approved in all of Europe and the United Kingdom, so I don’t understand it, Dr. Chapman doesn’t understand it, and a lot of my colleagues don’t understand it. So, we want answers, and that was the purpose of getting the word out to our colleagues.
Healio: What is your reaction to the response so far?
Gold: I think it is an amazing response. It is both optometrists and ophthalmologists who are doing this. It is important that what we are doing for our patients is working together as a team.
Healio: The petition calls for the approval of a low-dose atropine drop in general without mentioning SYD-101 or Sydnexis. What are your thoughts behind that?
Chapman: That was intentional. My organization, the American Academy of Orthokeratology and Myopia Control, also put out a statement in support of a commercially available preparation, and we did not mention Sydnexis there either. The reason is we don’t want to say we are specifically in support of Sydnexis. The message is that we are in support of a commercially available preparation of low-dose atropine that has been proven to be both efficacious and safe. Yes, the Sydnexis drop met those endpoints, but we would also support another company that would be able to meet those endpoints. We are volunteering our time because it is something that we believe in very strongly, and we would support any drug that proved to be safe and have good efficacy.
Healio: Why else should the FDA approve low-dose atropine?
Chapman: It is also about access to care. The patients who are currently receiving compounded low-dose atropine are doing so at their own out-of-pocket expense. There are other treatments we can do, such as orthokeratology and special types of soft contact lenses, but the problem is those are even more expensive, so we have a huge population that cannot afford treatment in any form. If low-dose atropine is commercially available, it opens up that insurance door in which insurance can be billed for it, and then I think about all those kids who are in lower-income families or have Medicaid who are now going to have access to care and can be treated.
Also, there are a lot of practicing eye doctors who don’t yet do myopia management. A potential benefit of this drug being approved as a commercially available preparation is that it will force doctors’ hands to participate because patients are going to ask for it. We need a little bit of public pressure for doctors who are lagging behind in innovation to make sure that they are staying on track with what is available.
There are also a lot of other impacts — emotional, self-confidence — when kids get these strong prescriptions. Study after study has shown that it affects their ability to succeed in life. They have trouble making eye contact. They feel self-conscious about the thickness of their glasses. They struggle playing sports. There is more than just this impact on disease progression later in life.
Healio: What is your outlook on the future of this issue?
Gold: I hope that at some point this medication, or another medication like it, will be approved — a commercially available, controlled medication, not a compounded medication, which has its own issues. And others will come along as well, in whatever formula it may be. It is my hope to have another tool in our toolbox that would be beneficial for our patients.
Chapman: I am feeling optimistic as well. There is a lot going on at the governmental level right now, and there are a lot of things in flux, but I do believe that a lot of that is going to get worked out, and I do believe that our voice will be heard. As the FDA reexamines this, I feel optimistic that it will look at this from a different perspective and that we will at some point have commercially available atropine.
For more information:
Cheryl Chapman, OD, FIAOMC, FAAO, Dipl ABO, can be reached at [email protected]. Robert S. Gold, MD, FAAP, can be reached at [email protected].
Sources/Disclosures
Source:
Healio Interviews
Reference:
Disclosures:
Chapman reports being an advisor for Sydnexis. Gold reports being an advisor/consultant for Sydnexis.
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