Why we need more tools in our tool kit for myopia progression

According to a publication by the National Academy of Sciences,¹ since December 2024, myopia has been defined as a disease rather than simply a refractive error. This means that all eye care professionals must view it as such and act accordingly—that is, treat it as a condition that can lead to blindness if it progresses to its full extent.

It must therefore be managed in the same way we manage glaucoma in our practices: There is an obligation to screen for it, perform the specific tests required (axial length measurement and cycloplegic refraction)² when the condition is suspected, and treat it or refer the patient to a colleague who can treat this condition if we cannot do so ourselves.

Fortunately, the management of myopia has been constantly evolving over the past 20 years,³ as science provides answers to our questions about the mechanisms and causes of this myopia epidemic. Researchers around the world are collaborating to develop innovative and effective products that meet clinical needs. For example, China has made the fight against myopia a national priority. The country has devoted enormous resources to supporting research, and its latest hub (China Eye Valley at Wenzhou Medical University) is a striking example of the vision to bring together key players so that basic research meets clinical research, thereby rapidly generating concrete solutions that can be quickly implemented in the field. We have a great deal to learn from these initiatives, and we must follow the leadership of these nations.

At the same time, in the US, regulatory agencies are imposing deadlines that seem incomprehensible to outsiders for approving products that have already proven themselves worldwide. Approval of highly aspherical lenslet (HAL) technology eyeglass lenses is a recent development in the US, even though the same lenses have been prescribed for over 6 years in Canada and Europe. How many children could have benefited from this technology yet had to endure a deterioration in their condition by wearing single-vision lenses? The harm caused is dramatically greater than the risks the agency may evoke regarding the impact of these lenses on children’s behavior.

By turning its back on science—both in the area of myopia and in health care in general—and by delaying the approval of effective treatments to slow the progression of myopia, the US is falling significantly behind other countries. This lag penalizes American researchers and practitioners. Far more seriously, it may put entire populations of children at risk, who will most certainly experience the consequences of this bureaucratic laxity as their myopia progresses to levels associated with blinding eye diseases.

It is also inexplicable that the same regulatory agencies recently refused to approve a low-dose atropine formulation based on new technology that ensures greater safety for users. Low-dose atropine is widely used by practitioners in the US to slow the progression of myopia.⁴ This medication is currently compounded. It has been well-documented that the formulation can vary from one laboratory to another and that the product’s stability is not always guaranteed.⁵ In short, what is actually in the bottle is not necessarily what was prescribed, and the product’s concentration and pH can vary over the course of 30 days of use. It is not surprising that variable results with this therapy are reported and that the dropout rate is high.⁶ Indeed, what child can endure instilling a formulation for months on end that stings, causes a burning sensation, dilates the pupil, and makes the patient sensitive to light?

The proposed new formulation is based on a new technology (heavy water) that is widely used.⁷ Heavy water vs distilled water increases the stability and pH of the low-dose atropine formulation. Providing a pH that is close to that of tears, making it a very comfortable drop to instill, it becomes a very attractive option for prescribing optometrists and ophthalmologists. They can therefore rely on a product that consistently meets their therapeutic goals. Patients would be assured of receiving the exact dose and product needed to treat their condition, without any uncertainty or variation in dosage depending on the quality of the compounding laboratory that produced the atropine.

Furthermore, the addition of a preservative helps keep the formulation sterile over a long period. It may help to lower the cost of the drug.⁸ This preservative agent also promotes a better absorption of the product⁹ and thus greater efficacy at a lower concentration. Lower concentration means increased safety and fewer adverse effects. On paper, this option therefore represents a significant improvement over the products currently available and certainly a safer alternative for young patients.

The US agency might be justified if the same conclusions had been reached elsewhere in the world. But that is not the case. This new 0.01% atropine formulation has been adopted in Europe and is about to be adopted in Asia. The US is therefore still lagging behind the rest of the world on this issue.

By depriving the American population of these products, the agencies are potentially condemning generations of children to an increased risk of vision-threatening conditions.¹⁰ This will affect the productivity of American society—we talk here of a loss of billions of dollars over the years (according to the World Health Organization)¹¹—and create a demand for eye care that will significantly inflate health care costs, which are already very high.

It is time for reason to prevail and for science to reclaim its rightful place. We are talking about children’s health and, above all, their future.

References

1. National Academies of Sciences, Engineering, and Medicine; Division of Behavioral and Social Sciences and Education; Board on Behavioral, Cognitive, and Sensory Sciences; Committee on Focus on Myopia: Pathogenesis and Rising Incidence. Myopia: Causes, Prevention, and Treatment of an Increasingly Common Disease. National Academies Press; 2024. doi:10.17226/27734

2. Gifford KL, Richdale K, Kang P, et al. IMI - clinical management guidelines report. Invest Ophthalmol Vis Sci. 2019;60(3):M184-M203. doi:10.1167/iovs.18-25977

3. Bullimore MA, Saunders KJ, Baraas RC, et al. IMI-interventions for controlling myopia onset and progression 2025. Invest Ophthalmol Vis Sci. 2025;66(12):39. doi:10.1167/iovs.66.12.39

4. Chia A, Lu QS, Tan D. Five-year clinical trial on atropine for the treatment of myopia 2: myopia control with atropine 0.01% eye drops. Ophthalmology. 2016;123(2):391-399. doi:10.1016/j.ophtha.2015.07.004

5. Richdale K, Skidmore KV, Tomiyama ES, Bullimore MA. Compounded 0.01% atropine-what's in the bottle? Eye Contact Lens. 2023;49(6):219-223. doi:10.1097/ICL.0000000000000990

6. Santodomingo-Rubido J, Martínez-Pérez C, Villa-Collar C. Dropout rates among optical interventions for myopia control: a systematic review. Cont Lens Anterior Eye. 2025;49(2):102601. doi:10.1016/j.clae.2025.102601

7. Wang X, Liu NM, Zhao YF, Yang F, Zhu ZJ, Song D. Research progress in the medical application of heavy water, especially in the field of D2O-Raman spectroscopy. Int J Med Sci. 2022;19(8):1357-1363. doi:10.7150/ijms.73150

8. Steven DW, Alaghband P, Lim KS. Preservatives in glaucoma medication. Br J Ophthalmol. 2018;102(11):1497-1503. doi:10.1136/bjophthalmol-2017-311544

9. Baudouin C, Labbé A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eye drops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29(4):312-334. doi:10.1016/j.preteyeres.2010.03.001

10. Gifford KL. Childhood and lifetime risk comparison of myopia control with contact lenses. Cont Lens Anterior Eye. 2020;43(1):26-32. doi:10.1016/j.clae.2019.11.007

11. Noncommunicable Diseases, Rehabilitation and Disability (NCD); Sensory Functions, Disability and Rehabilitation (SDR); World Health Organization. World Report on Vision. World Health Organization. October 8, 2019. Accessed March 21, 2026. https://www.who.int/publications/i/item/world-report-on-vision