FDA Rejection of Low-Dose Atropine Sparks Industry Petition and Calls for Myopia Reclassification
核心洞察
More than 800 eye care practitioners have signed a petition urging the FDA to approve low-dose atropine (搜索) for pediatric myopia (搜索) control after the agency rejected SYD-101 despite meeting all efficacy endpoints.
The American Academy of Orthokeratology and Myopia Control (搜索) released a statement calling for the US to reexamine progressive myopia (搜索) classification as a chronic disease requiring pharmaceutical intervention.
Current access to myopia (搜索) control is limited to expensive out-of-pocket compounded atropine (搜索) or costly optical interventions, creating barriers for lower-income families and Medicaid patients.
The FDA's October 2024 decision to reject SYD-101, a 0.01% atropine formulation from Sydnexis (搜索) for pediatric myopia (搜索) control, has triggered unprecedented pushback from the eye care community, with over 800 practitioners signing a petition demanding regulatory reconsideration.
The Change.org petition, posted December 9 by the Pediatric Progressive Myopia Coalition (搜索)—a partnership between pediatric ophthalmologist Robert S. Gold, MD, and optometrist Cheryl Chapman, OD—has garnered 817 signatures from both optometrists and ophthalmologists. The coalition formed after the FDA's surprising rejection of SYD-101, despite the agency acknowledging the drug met its primary efficacy endpoint in phase 3 trials with no safety or quality issues.
Regulatory Disconnect Sparks Professional Outcry
"We were fully expecting the low-dose atropine (搜索) from Sydnexis (搜索) to be approved in October 2025," Chapman said. "When it wasn't, it really riled us all up and got us thinking, 'Hey, what can we do to help raise awareness?'"
The rejection has highlighted what practitioners view as inconsistent regulatory standards. Gold emphasized 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."
The American Academy of Orthokeratology and Myopia Control (搜索) (AAOMC (搜索)) released a statement noting the regulatory disconnect within the FDA itself. While the agency's device division has approved several optical interventions for myopia (搜索) management, the Drug Ophthalmology division has not extended similar recognition to pharmaceutical therapies.
International Approvals Highlight US Regulatory Gap
The European Commission approved a low-dose atropine (搜索) ophthalmic solution for children aged 3-14 years with progressive myopia (搜索) in 2024, with the UK following suit in November 2025. These approvals contrast sharply with the US position, despite what practitioners describe as robust peer-reviewed evidence demonstrating "clinically meaningful reductions in axial elongation and myopia (搜索) progression, with excellent safety and tolerability profiles."
Marie Homa-Palladino, OD, director of the MOA Myopia Management Center (搜索) and AAOMC (搜索) secretary, noted that while the organization respects the FDA's heightened responsibility for pediatric medications, "the approval of low-dose atropine (搜索) in other leading regions naturally invites questions from clinicians, parents, and industry partners."
Access and Equity Concerns Drive Advocacy
Beyond regulatory frustration, practitioners emphasize the access barriers created by the current system. Compounded atropine (搜索) is available for patients who can pay out-of-pocket, but an FDA-approved formulation would address issues with stability, consistency, and accessibility.
"The patients who are currently receiving compounded low-dose atropine (搜索) are doing so at their own out-of-pocket expense," Chapman explained. "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."
The access issue particularly affects lower-income families and Medicaid patients, who currently have limited options for myopia (搜索) control. Alternative treatments like orthokeratology and specialty soft contact lenses are even more expensive than compounded atropine (搜索).
Disease Classification at Center of Debate
The AAOMC (搜索) statement calls for fundamental changes in how progressive myopia (搜索) is addressed in the US regulatory framework. The organization advocates for formal recognition of myopia (搜索) as a chronic, progressive disease with lifelong consequences for vision and ocular health.
"This is a disease. This is not a benign situation," Gold emphasized. "This disease can cause major visual problems—things like glaucoma (搜索), cataracts (搜索), retinal detachments (搜索). We're trying to slow down that progression and those risks."
The organization outlined three key objectives for reimagining myopia (搜索) care in the US:
- Achieving formal recognition of myopia as a disease
- Identifying pathways for access to safe, standardized, approved pharmaceutical interventions
- Integrating low-dose atropine into comprehensive myopia control strategies
Broader Impact on Pediatric Patients
Beyond the clinical implications, practitioners highlight the psychosocial impact of progressive myopia (搜索) on children. Chapman noted that "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."
The petition strategically avoids endorsing Sydnexis (搜索) specifically, instead calling for approval of any low-dose atropine (搜索) formulation that proves safe and efficacious. "We would support any drug that proved to be safe and have good efficacy," Chapman clarified.
Looking Forward
Despite current regulatory challenges, both Gold and Chapman express optimism about future approvals. Chapman noted that "there are a lot of things in flux" at the governmental level but believes "our voice will be heard" as the FDA reexamines the issue.
The controversy has also highlighted the need for broader practitioner engagement in myopia (搜索) management. Chapman suggested that commercial availability of low-dose atropine (搜索) could "force doctors' hands to participate because patients are going to ask for it," potentially accelerating adoption of evidence-based myopia control practices.
As Homa-Palladino emphasized, "Optometry must accept progressive myopia (搜索) as one of its greatest public health responsibilities," positioning optometrists at the center of what advocates describe as a necessary paradigm shift in pediatric eye care.