TOPLINE: Myopia affects roughly one third of the population worldwide ― a figure that is projected to reach 50% by 2050. Low-dose atropine, which helps curb the condition, currently is available in the United States only through compounding pharmacies. The products contain preservatives ― raising questions about potential toxicities to the eye ― and may not be of pharmaceutical grade. In a new study published in JAMA Ophthalmology, a preservative-free eyedrop containing 0.01% atropine led to significant improvements in several markers of myopia in children who received the experimental therapy.
The CHAMP study was a double-masked, placebo-controlled, randomized phase 3 trial conducted between November 20, 2017, and August 22, 2022, that involved children at 26 sites in North America and five centers in Europe.
Children received either 0.01% or 0.02% atropine drops once per day.
Patients were aged 3 to 16 years. They demonstrated a spherical equivalent refractive error (SER) of −0.50 diopter (D) to −6.00 D astigmatism no worse than −1.50 D.
Of these patients, 573 were included in a safety analysis, and 489 were included in a modified intention-to-treat analysis.
After 36 months, the 0.01% dose of atropine was associated with a significantly lower responder proportion (odds ratio [OR], 4.54) and slower progression of SER and axial elongation.
The effect of the 0.02% dose on responder proportion and SER progression was not statistically significant, but the treatment was associated with slower axial elongation.
The researchers observed no serious ocular adverse events and few serious nonocular events, none of which was determined to be associated with the treatment.
IN PRACTICE: According to the researchers: “From a risk/benefit perspective, the efficacy and safety observed suggests that low-dose atropine may provide a treatment option for children aged 3 to 17 years with myopia progression, which may lead to less frequent or delayed change in glasses, progression to less severe correction, and potentially reduce long-term sequelae, which could lead to vision loss later in life, such as myopic maculopathy.”
STUDY DETAILS: The CHAMP study was led by Karla Zadnik, OD, PhD, of the Ohio State University, and was funded by Vylulma Inc.
LIMITATIONS: The researchers said the trial was potentially limited by the fact that patients switched from the study drug to confounding treatments. In addition, patients at the low and high age ranges were not well represented.
DISCLOSURES: Zadnik received consultant fees from Vyluma Inc during the study.
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