Treating myopia today: US-focused treatments, challenges, and global insights

Pediatric progressive myopia is a growing global public health concern, linked to serious ocular complications including myopic macular degeneration, retinal detachment, glaucoma, and cataracts.^1-3 Multiple treatment options exist globally, and US regulatory approvals have only recently expanded.

Surveying the current landscape

Randomized clinical trials support several effective myopia control strategies. Among these is the use of low-dose atropine (0.01%-0.05%), which has been shown to reduce myopic progression by 30% to 60%, depending on the concentration and the formulation.^4-6 Dual-focus and defocus spectacle lenses—eg, defocus incorporated multiple segments (DIMS) and highly aspherical lenslets (HALs)—have been shown to slow axial elongation by approximately 30% to 50%.^7,8 The MiSight 1 day (CooperVision) is the first FDA-approved contact lens treatment, showing approximately 59% reduction in myopic progression over 3 years.^9,10 Orthokeratology (ortho-K) and soft multifocal contact lenses likely provide moderate efficacy (35%-45% reduction in myopic progression). However, ortho-K carries a higher potential risk of microbial keratitis in children.^11,12

Additionally, increased time outdoors (40-80 minutes per day) has been shown effective at reducing the onset of myopia in children who are nonmyopic.^13-15

Other interventions have not demonstrated clinically meaningful benefit. These include the undercorrection of refractive error; use of blue-light filtering lenses; standard bifocals and progressive addition lenses; pinhole or “training” glasses, and standard soft or rigid gas-permeable lenses. These approaches either lack biological plausibility or have failed in controlled trials.

Low-dose atropine

Low-dose atropine remains the most extensively studied and effective pharmaceutical treatment and can be used in children as young as 3 years. Large trials in Asia, including ATOM2 and LAMP, have demonstrated consistent reduction in both myopic progression and axial elongation.^4,5 With the nonpreserved formulation used and population treated in the LAMP trial, 0.05% appeared to be the most effective concentration with acceptable tolerability.⁵ When low-dose atropine is used in various studies, the labeled concentration (0.05%) does not necessarily capture the clinical effect, which is influenced by formulation-specific factors such as pH, preservatives, and bioavailability.

Atropine also likely delays myopia onset in children who are premyopic although individual response varies by age, ethnicity, and environmental exposure.^16,17

Formulation matters

Compounded atropine in the US frequently lacks consistency in drug concentration, pH, and preservative content, raising concerns regarding efficacy, sterility, and patient adherence.^18-20

A 2025 ARVO poster by Sydnexis showed superior mydriatic response and corneal penetration in rabbits with BAK-preserved eye drops near physiologic pH compared with preservative-free acidic formulations.²¹

Current regulatory landscape

Several low-dose atropine products are approved internationally, including the following:

• Australia: Eikance 0.01% (Aspen)
• China: Sinqi 0.01% (SQ-729)
• India: Myatro XL 0.05% (Entod)
• Europe (EMA): Ryjunea 0.01% (Santen); the branded version of SYD-101 (Sydnexis)

In the US, SYD-101 is currently under FDA review with a PDUFA date of October 23, 2025.

Optical interventions

Contact lenses

The MiSight 1 day (CooperVision) remains the only FDA-approved contact lens therapy for myopia control in children aged 8 to 12 years. MiSight has shown sustained reduction in myopic progression (0.67 D) and axial elongation (0.28 mm) over 3 years, with continued benefit through 6 years.^9,10 Other soft contact lenses—including extended depth of focus and center-distance multifocal lenses such as NaturalVue (Visioneering Technologies, Inc) and Biofinity (CooperVision)—are commonly used off-label in the US and have shown moderate efficacy in clinical trials.^22,23

Ortho-K uses a hard contact lens to temporarily reshape the cornea overnight and has demonstrated a 0.2 to 0.3 mm reduction in axial elongation over 2 years.^24-26 Overnight contact lens wear carries a higher potential risk of infectious keratitis in pediatric patients and there are limited data on progression once the lenses are discontinued.^11,12 Some smaller studies have shown synergistic effects of low-dose atropine and orthokeratology, though many of these studies are limited by a lack of placebo control.^27,28

Spectacle lenses

Spectacle-based myopia control strategies have gained significant international traction, with the following approved in Europe:

• MiyoSmart (HOYA): DIMS²⁹
• Stellest (Essilor): HALs⁷
• SightGlass Diffusion Optics Technology lenses: Light-scattering technology to reduce retinal contrast³⁰

In the US, on September 25, 2025, the FDA authorized marketing of the Essilor Stellest lenses to correct myopia with or without astigmatism and to slow the progression of the disease in children 6 to 12 years old at the initiation of treatment.³¹

Behavioral and environmental interventions

Increasing outdoor exposure to 40 to 80 minutes per day is strongly associated with delayed onset and slower progression of myopia. This effect is well documented across several large studies.^13-15

In addition, limiting sustained near work, especially at close viewing distances less than 20 cm, and promoting regular breaks from screen time and reading are also likely beneficial.^32,33 These strategies are low-cost, low-risk, and should be recommended alongside optical or pharmacologic therapy.

Repeated low-level red light

Among emerging therapies, repeated low-level red light (RLRL) therapy has demonstrated promising early results; however long-term safety remains uncertain. Risks include potential retinal injury and rebound axial elongation after discontinuation.^34,35RLRL devices in use across Asia and Australia are not cleared by the FDA, and some may exceed ANSI exposure thresholds.³⁶

Conclusion

Treatment for myopia progression in the US is advancing, with new options such as the MiSight 1 day contact lens and the recently approved Essilor Stellest spectacle lens.

Low-dose atropine, although commonly prescribed off-label, is limited by inconsistencies in its formulation, which can affect both effectiveness and patient adherence. The FDA’s pending review of SYD-101 could mark the beginning of a new era in standardized pharmacologic treatment.

Globally, new developments in spectacle and contact lens technologies add further promise, while behavioral interventions remain an essential part of therapy.

Clinicians must continue to weigh the benefits and risks of off-label strategies while prioritizing early intervention to reduce the lifelong burden of high myopia.

References

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