New Myopia Management: Low Dose Atropine

Atropine has been used off-label for decades as a safe and effective monotherapy option or as a counterpart to orthokeratology or combination therapy with soft multifocal contact lenses.

While the use of atropine is not necessarily new to the world of myopia management, the fact that practitioners may soon have an FDA-approved formulation of atropine is new and exciting. (Adobe Stock/Andrey Kuzmin)

In addition to the lack of commercial availability, one of the major barriers to successful implementation in routine practice is the current lack of FDA approval. Parents and practitioners alike often shy away from this drug option due to the lack of extensive evidence regarding its safety and efficacy.

Guiding our way now are the results of clinical trials such as low-dose atropine (LAMP) for myopia progression and atropine (ATOM1/ATOM2) for the treatment of pediatric myopia. Despite the wealth of information available from these studies, there is currently no solid or conclusive evidence regarding the ideal concentration of atropine.

The Pediatric Atropine (CHAMP) Trial for Myopia Progression is the most successful trial to date. This is his three-arm, randomized, double-mask, placebo-controlled clinical trial sponsored by Vyluma. 1,2 The tested formulation is shelf-stable at room temperature, preservative-free, and administered once daily in the evening.

At both US and European sites, the trial included children aged 3 to 17 years of various ethnic backgrounds with myopia ranging from -0.50 DS to -6.00 D DS and astigmatism of -1.50 D or less. was included.

The trial is currently in Phase 3 and so far both the 0.01% and 0.02% low-dose formulations have been determined to be safe with few adverse events. Furthermore, 0.01% was effective in slowing the progression of myopia as evidenced by measurements of spherical equivalent refractive error and axial length when compared to placebo after 3 years.

If approved, the drops will be the first and only drug to treat the progression of childhood myopia.

Although we are one step closer to adding additional FDA-approved options to our myopia management repertoire, there are still many open questions. However, the addition will undoubtedly allow practitioners to manage more patients, but especially those with limited options due to age, ability, and financial concerns.

References

1. Vyluma CHAMP pivotal Phase 3 clinical trial Q&A. A review of myopia management. Published October 27, 2022. Accessed May 9, 2023. https://reviewofmm.com/vyluma-champ-pivotal-phase-3-clinical-trial-qa/

2. Vyluma CHAMP pivotal Phase 3 clinical trial Q&A. A review of myopia management. Published October 27, 2022. Accessed May 9, 2023. https://reviewofmm.com/vyluma-champ-pivotal-phase-3-clinical-trial-qa/

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