MYOPIA is a widespread public health concern affecting billions of people and increasing the risk for sight-threatening ocular comorbidities (Holden et al, 2016). Studies have demonstrated that a variety of interventions spanning soft and rigid contact lenses, spectacle designs, and pharmaceutical agents can slow the progression of myopia (Huang et al, 2016; Lawrenson et al, 2023). Despite this, some eyecare practitioners (ECPs) in the U.S. are hesitant to embrace myopia management due to the dearth of U.S. Food and Drug Administration (FDA)-approved interventions for myopia progression control.
OFF-LABEL BUT EVIDENCE-BASED
Many ECPs regularly use products off-label to treat their patients; in fact, in some cases this may even be the standard of care (Murphy, 2015). Topical steroids are often used off-label for dry eye signs or symptoms, while topical antibiotics, which are often only indicated for the treatment of bacterial conjunctivitis, are regularly employed outside of their FDA approvals (Thomas et al, 2022).
As practitioners, how did we become comfortable using these therapies off-label? Simple…because they work. When evidence becomes available that a treatment is safe and effective outside of its approved indication, it is prudent for (and arguably a responsibility of) practitioners to consider this application for their patients. This is reflected in a new Myopia Management Clinical Report from the American Optometric Association (AOA) Evidence-Based Optometry Committee, which provides guidelines on when to initiate myopia management and discusses many interventions, nearly all of which do not have FDA approval for myopia progression control (AOA, 2021).
ARE MYOPIA TREATMENTS TRULY OFF-LABEL?
Less than three years ago, there were no FDA-approved interventions for myopia progression control in the U.S. Today, there is only one—a soft contact lens. However, even that contact lens’s approval is limited to ages 8 to 12 years, astigmatism less than or equal to –0.75D, and myopia of less than or equal to –7.00D, meaning fitting outside of these parameters would constitute off-label use.
When it comes to myopia interventions, it is important to note that there are a variety of optical and pharmacological agents that have regulatory body approval outside of the U.S., some of which are available to U.S.-based practitioners. Furthermore, some of these options, such as certain soft contact lenses and orthokeratology designs, actually are on-label for the correction or management of myopia, often with no age restriction. While this does not imply FDA approval for myopia progression control, it means that simply using these treatments in children should not be regarded as off-label use.
CALL TO ACTION
Practitioners should understand that a lack of FDA approval does not indicate that an intervention is unsafe or ineffective. It is encouraging to now have an FDA-approved treatment for myopia progression control for certain patients, but practitioners should not limit myopia management to a specific patient population or a single treatment modality.
In addition to regulatory approval from the FDA or other bodies, ECPs should evaluate all available treatment options based on factors such as published data, duration of follow-up reported, recommendations of professional organizations and subject matter experts, and their own experiences as well as those of their colleagues. CLS
- Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123:1036-1042.
- Huang J, Wen D, Wang Q, et al. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123:697-708.
- Lawrenson JG, Shah R, Huntjens B, et al. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2:CD014758.
- Murphy J. Off Label, But On Target. Rev Optom. 2015 Jan 15.
- Thomas R, Melton R, Vollmer PM. Clinical Perspectives on Patient Care. Rev Optom Supplement. 2022 Aug 15.
- AOA Evidence-Based Optometry Committee. Clinical Report: Myopia Management. 2021. Available at aoa.uberflip.com/i/1388672-ebo-myopia-clinical-report-no-spread/0? . Accessed Oct. 30, 2023.