AAO 2023: Phase III CHAMP and more trials pioneering myopia management in children

(Image Credit: AdobeStock/ryanking999)

Three new studies, including a new global study showing that low-dose atropine can help slow myopia in children will be presented at this year’s annual AAO meeting.

Darren J Bell, MD, of Medical Center Ophthalmology Associates in Texas, is one of the investigators of the new study. The Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study was a 3 year, placebo-controlled international trial, and analysis from Bell showed low-dose, preservative-free formulation of atropine is effective in slowing progression in children aged 3 to 17, living in the US and European Union.

The children had between −0.50 D to −6.00 D spherical equivalent refraction and received daily placebo or a proprietary formulation of low-dose atropine. The proportion of responders compared with placebo was: 31.6%/21.3% (<0.50 D, P = .007), 42.8%/29.4% (<0.75 D, P = .001) and 54.8%/43% (<1.00 D, P = .006) at 3 years.

The US FDA accepted a NDA for the investigational drug used in this study, with a decision on its approval expected in January 2024.

“We found that low-dose atropine is suitable for all children with myopia, regardless of age, sex, race, iris color, or baseline spherical equivalent refraction,” said Bell. “These results are a major advance for myopia management and for the kids and parents who myopia impacts.”

Other notable studies on slowing myopia in children being presented at AAO include:

• Factors Associated With Myopia Progression in Children 5 to 12 Years of Age (PO409)
  
  The authors conclude that younger children with greater baseline myopia should be the focus of myopia control strategies. Researchers conducted a pooled analysis of 187 children with myopia who were randomized to nightly 0.01% atropine or placebo for 2 years, followed by 6 months of no treatment. The analysis also showed that race, sex, and iris color were not associated with atropine’s success rate.

• Five-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 4 Report (PO411).
  
  An extension of the original LAMP trial, it followed 257 children in China for 5 years, aged 4 to 12, who were treated with higher-dose atropine, 0.05%. Researchers found that the higher dose was effective and that by year 4 and 5 follow-up, as-needed treatment could be considered for older children when their progression was stable.