Analysis of data from the European Union and the United States showed low-dose, preservative-free formulation of atropine is effective in slowing myopia progression in children
Three new studies, including a new global study showing that low-dose atropine can help slow myopia in children, were presented at this year’s annual AAO meeting.
Darren J Bell, MD, of Medical Center Ophthalmology Associates in San Antonio, Texas, United States, 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. 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 presented at AAO include: