The organization reaffirmed that it stands by myopia defined as a chronic, progression disease.
Sparked by the recent complete response letter (CRL) received by Sydnexis from the US FDA regarding its 0.01% atropine formulation (SYD-101), the American Academy of Orthokeratology and Myopia Control (AAOMC) recently released a statement urging the US to reexamine the classification of progressive myopia.1,2 The organization reaffirmed that it stands by myopia defined as a chronic, progressive disease that has lifelong consequences for vision and ocular health if not managed.1
“Recent regulatory developments in the United States have highlighted a key gap within the US FDA drug regulatory framework. While the FDA’s device division has approved several tools for myopia management, including optical interventions that slow myopia progression, the FDA Drug Ophthalmology division has not yet extended that same recognition to pharmaceutical therapies. The recent decision not to approve a low-dose atropine formulation underscores the need to reexamine how progressive myopia is classified and addressed within the US drug regulatory framework,” the AAOMC said in the statement.
Marie Homa-Palladino, OD, FIAOMC, IACMM, director of the Medical Optometry America Myopia Management Center and AAOMC secretary, told Optometry Times that although the AAOMC respects the FDA’s decision, SYD-101’s integration into other countries’ medical systems should raise questions on how myopia is addressed within the US drug regulatory framework. The organization’s statement cited that the European Commission approved a low-dose atropine ophthalmic solution for children aged 3 to 14 years with progressive myopia this year, with the UK approving the same therapy for pediatric myopia management in November 2025.1
“The AAOMC respects the FDA's heightened responsibility to ensure the safety, efficacy, and long-term impact of any new medication considered exclusively for treating children,” Homa-Palladino said. “Any therapy aimed at a pediatric population requires rigorous scientific evaluation, and we fully respect the FDA's decision not to grant approval for low-dose atropine to treat pediatric progressive myopia at this time.
“However, the approval of low-dose atropine in other leading regions—including the European Union—naturally invites questions from clinicians, parents, and industry partners. These international approvals suggest confidence in the medication’s potential benefits and underscore the need for continued collaboration and clarity so that families can make informed decisions and practitioners can offer the most responsible care options. These points highlight the need to reexamine how progressive myopia is classified and addressed within the US drug regulatory framework, as it is a serious condition with long-term ocular health consequences.”
Although the CRL stated that the evidence from the phase 3 Study of Atropine for the Reduction of Myopia Progression trial that was cited in the new drug application achieved its primary efficacy end point, the FDA concluded that the evidence did not demonstrate the effectiveness of low-dose atropine for treating myopia in children.2 However, the AAOMC stated that “the body of peer-reviewed evidence is robust: low-dose atropine has demonstrated clinically meaningful reductions in axial elongation and myopia progression, with excellent safety and tolerability profiles.”1
In order to reimagine how myopia is addressed in the US, the AAOMC stated that regulators, industry partners, and the broader eye care community should work together to:
“Shifting perceptions of pediatric myopia requires a fundamental paradigm shift for both providers and parents,” Homa-Palladino told Optometry Times. “Optometrists must first recognize progressive myopia as a significant visual liability throughout a patient's life and stay educated on this fact. After internalizing the importance, staying up-to-date on all available evidence-based treatments is vital. This combination of knowledge and commitment provides ODs [doctors of optometry] with the necessary discussion points to initiate conversations with unsuspecting patients and their parents. As the primary eye care providers in the United States, ODs must remain at the forefront of this challenge. Optometry must accept progressive myopia as one of its greatest public health responsibilities.”
