Low-dose atropine slows myopia progression in children aged 3 to 17 years
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SAN FRANCISCO — A low-dose, preservative-free formulation of atropine is effective in slowing myopia progression in children aged 3 to 17 years, according to phase 3 data presented here.
“Over 3 years, NVK002 0.01% meaningfully slowed myopia progression at 0.5 D, 0.75 D and 1 D thresholds,” Darren J. Bell, MD, said at the American Academy of Ophthalmology meeting.
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Bell reported results from the phase 3 CHAMP clinical study, which evaluated children with –0.5 D to –6 D spherical equivalent refraction. Participants were randomly assigned to receive either placebo or NVK002 0.01%. In total, 165 subjects received placebo and 164 received NVK002.
At 3 years, the proportion of responders vs. placebo was 31.6% vs. 21.3% in those with less than 0.5 D (P = .007), 42.8% vs. 29.4% in those with less than 0.75 D (P = .001) and 54.8% vs. 43% in those with less than 1 D (P = .006). The FDA has accepted a new drug application for NVK002 0.01%, with a decision expected in January 2024.
A separate pooled analysis of 175 children conducted by Michael X. Repka, MD, MBA, and colleagues found that low-dose atropine works best in children aged younger than 10 years. Their analysis also showed that East Asian race, sex and iris color had no association with atropine’s success rate.
“Younger children with greater myopia should be the focus of future myopia control studies in the U.S.,” Repka said.
Another study conducted by Jason C.S. Yam, FRCS(Ed), MBBS, and colleagues found that higher-dose 0.05% atropine was effective in Chinese children aged 4 to 12 years.
“Re-treatment was suggested for those who have experienced myopia progression after stopping treatment,” Yam said. “When we restarted treatment, the efficacy was quite good even compared to continued treatment.”
References:
- Bell DJ, et al. Low-dose atropine for treatment of pediatric myopia progression: Analysis of responders by SER progression over 3 years. Presented at: American Academy of Ophthalmology meeting; Nov. 3-6, 2023; San Francisco.
- Repka MX, et al. Factors associated with myopia progression in children 5 to 12 years of age. Presented at: American Academy of Ophthalmology meeting; Nov. 3-6, 2023; San Francisco.
- Yam JCS. Five-year clinical trial of low-concentration atropine for myopia progression (LAMP) study: Phase 4 report. Presented at: American Academy of Ophthalmology meeting; Nov. 3-6, 2023; San Francisco.
Perspective
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There is not a day in a pediatric ophthalmology practice that we are not faced with patients of different ages dealing with the progression of myopia. There have been mixed reports of different strengths of atropine drops, which have been effective to decrease the progression of myopia and some that have not shown any significant benefit.
At the AAO meeting in San Francisco, three posters have been presented showing the benefit of these drops. Bell, reporting for the phase 3 CHAMP (Childhood Atropine for Myopia Progression), showed that “low-dose atropine is suitable for all children with myopia regardless of age, sex, race, iris color or refraction.” Their study was in children aged 13 to 17. The medication has been submitted for FDA approval, with a decision expected in January 2024. Poster 409, “Factors associated with myopic progression in children ages 5 to 12,” showed low-dose atropine (0.01%) worked best in children younger than age 10 years. And another poster from the LAMP study phase 4 showed that higher-dose atropine (0.05%) was effective.
From my perspective, each pediatric ophthalmologist needs to use all this information to bring to their myopic patients every day in their practice. It is imperative to take the time to discuss the various options to treat myopic progression at any appropriate age and help parents make the best decision for their child. The five pediatric ophthalmologists in my practice have different ways to approach this treatment. We have information that we hand out to parents, and we discuss in the exam room and on the phone the various options. Sometimes decisions are made right away, and sometimes parents need to think it over. They worry about putting an eye drop in their child’s eye every night for maybe years and not knowing how long the treatment will be.
My personal experience with low-dose atropine has shown great results in my patient population to slow myopic progression. I start with 0.01% and increase as needed, but I have rarely had to do so. Others may have different experiences and results, but the bottom line is that we have treatments available to try to slow myopic progression and should be advocates to offer them to our patients.
References:
- Bell DJ, et al. Low-dose atropine for treatment of pediatric myopia progression: Analysis of responders by SER progression over 3 years. Presented at: American Academy of Ophthalmology meeting; Nov. 3-6, 2023; San Francisco.
- Repka MX, et al. Factors associated with myopia progression in children 5 to 12 years of age. Presented at: American Academy of Ophthalmology meeting; Nov. 3-6, 2023; San Francisco.
- Yam JCS. Five-year clinical trial of low-concentration atropine for myopia progression (LAMP) study: Phase 4 report. Presented at: American Academy of Ophthalmology meeting; Nov. 3-6, 2023; San Francisco.
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