Abstract
Purpose :
In the Phase 3 CHAMP trial for myopic children in the US and Europe, NVK002 atropine 0.01% slowed myopia progression, with significantly more children progressing less than 0.50D in myopia over 3 years than placebo. It also reduced the mean increase in axial length (AL) and the mean change in spherical equivalent refractive error (SER) over three years. A time to event (TTE) analysis was performed to quantify the hazard reduction provided by NVK002 compared to placebo in children over the course of the study.
Methods :
In the CHAMP study, US and European participants aged 3 to ≤17 years with SER between −0.50 D to −6.00 D were randomized to receive once-nightly placebo (n=165), NVK002 0.01% (n=164), or 0.02% (n=247) eye drop for 36 months. TTE analysis for both concentrations was performed by quantifying the hazard ratio (HR) for NVK002 compared to placebo for both event definitions of - 0.50 D and - 0.75D myopia progression in a modified intent-to-treat (mITT) population (participants 6 to 10 years of age at baseline).
Results :
Over a three-year period, nightly dosing with NVK002 at concentrations of 0.01% and 0.02% was compared to placebo in delaying myopia progression in children, as measured by SER. TTE analysis is particularly useful in handling dropouts without artificial imputation of missing. It revealed that both concentrations of NVK002 significantly reduced the hazard rate of time-to-progression of - 0.50D and - 0.75D compared to placebo. Specifically, the 0.01% dosage reduced the hazard rate by 29.2% (HR=0.708 [95% CI: 0.545, 0.921], p=0.01) and 32.1% (HR=0.679 [95% CI: 0.511, 0.903], p=0.008) for the - 0.50D and - 0.75D event definition, respectively. The 0.02% dosage showed a reduction in hazard rate by 28.5% (HR=0.715 [95% CI: 0.567, 0.902], p=0.005) for the - 0.50D event definition and by 24.3% (HR=0.757 [95% CI: 0.593, 0.967], p=0.026) for the - 0.75D event definition.
Conclusions :
The TTE analysis indicates a clear therapeutic benefit of both concentrations of NVK002 over placebo in controlling myopia progression using clinically meaningful endpoints. This evidence further supports the potential of NVK002 as a treatment for myopia management in the pediatric population, offering a promising avenue to mitigate the long-term ocular complications associated with myopic progression.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.