A novel, preservative-free atropine formulation may be able to slow axial growth and spherical equivalent refraction (SER) progression in a broad age range of children (age range, 3-17 years), according to a poster presented at the American Optometric Association 2023 ePosters virtual event from June 13-14, 2023 in Washington, DC.
The research team, led by Kristen Kerber, OD, of the New England College of Optometry, included individuals with myopia (SER, −0.50 to −6.00) who were randomly assigned to once daily treatment with the novel, preservative-free atropine formulation or placebo. The team included individuals aged 6 to 10 years in a modified intent-to-treat (mITT) subgroup analysis (treatment group, n=133; placebo, n=144) and individuals aged 3 to 17 years in an intent-to-treat assessment (ITT; treatment group, n=164; placebo, n=165). The efficacy endpoints were the proportion of responders and mean SER and axial length changes at the 36-month study conclusion in both the mITT and ITT groups.
Treatment with the novel, preservative-free atropine formulation increased the proportion of responders compared with placebo treatment in both mITT (28.5% vs 17.5%; odds ratio [OR], 3.9; P =.031) and ITT analyses (31.6% vs 21.3%; OR, 3.9; P =.035), the poster shows. The novel, preservative-free atropine treatment also significantly slowed both mean SER progression (mITT: 0.24 diopters [D] least square mean difference [LSMD]; ITT: 0.25 D LSMD) and axial elongation (mITT: -0.13mm LSMD; ITT: -0.13mm LSMD; P <.001 for mITT and ITT).
“Analyses of the mITT and ITT sets showed comparable percentages of responders to NVK002 0.01% [the novel, preservative-free atropine formulation] treatment for the two groups,” according to the poster presenters. “These results suggest that the inclusion of data from subjects of ages 3 to 17 years (ITT) rather than ages 6 to 10 years (mITT) may not alter the efficacy of NVK002 0.01% in the CHAMP trial, and NVK002 0.01% may be suitable to treat myopic children with a broad age range.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Kerber K, Vera-Diaz F, Chandler S, Fong T, Lang E, Hemmati H. Comparison of efficacy between intent-to-treat (ITT) and modified ITT populations of NVK002, a novel formulation of low-dose atropine, in treating myopia progression in children in the CHAMP clinical trial. Poster presented at: American Optometric Association 2023 ePosters Virtual Event; June 13-14, 2023; Washington, DC.