Abstract
Purpose :
Myopia remains the leading refractive disease in the world with increasing prevalence among children and adolescents. Although atropine was shown to slow myopia progression, there are differences in efficacy results across various studies which may reflect differences in study population, study design and/or atropine formulation. Here, we compare the efficacy results from the Phase 3 CHAMP trial of NVK002 to 5 other published studies.
Methods :
This analysis compares 24-month efficacy results from a 3-year randomized, double-masked, placebo-controlled Phase 3 CHAMP trial evaluating NVK002 (atropine) 0.01% and 0.02% to 5 published randomized placebo-controlled trials. In the CHAMP study, subjects in the US and Europe aged 3 to ≤17 years with spherical equivalent refraction (SER) between −0.50 D to −6.00 D were randomized to receive once-nightly placebo, NVK002 0.01%, or 0.02% eye drop for 36 months. Efficacy results at 24 months include the proportion of responders (<0.50 D myopia progression), and mean change from baseline in SER and axial length in a modified intent-to-treat (mITT) population (subjects 6 to 10 years of age at baseline).
Results :
In CHAMP, at Month 24, the proportion of responders (<0.50 D myopia progression) was clinically meaningful and significantly higher with NVK002 0.01% when compared to placebo (p=0.049). NVK002 0.01% slowed mean SER progression compared to placebo (p=0.002). Compared to placebo, both NVK002 0.01% and NVK002 0.02% significantly slowed mean axial elongation (p<0.001 & p=0.011, respectively). Compared to published studies, placebo-subtracted responder proportion for NVK002 0.01% was comparable to 3 other studies (Wei 2020; Saxena 2021; Yam 2019) at Month 12. At Month 24 placebo-subtracted SER change from baseline for NVK002 0.01% (0.22D) was comparable to that of Hieda 2021 (0.22D) and Lee 2022 (0.14D). Axial elongation comparison was similar to SER progression comparison.
Conclusions :
Over 24 months, NVK002 0.01% demonstrated meaningful and comparable efficacy in slowing myopia progression compared to 5 other published trials. Among these, NVK002 is the only stable, preservative-free atropine with 36-month clinical data with concurrent placebo control or clinical data from US and Europe.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.