New research presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) annual meeting demonstrates promising data supporting the use of low-dose atropine (NVK002) for mitigating myopia progression.
Tell me about NVK002.
NVK002 is a preservative-free, low-dose atropine formulation developed by Vyluma that features proprietary technology to address stability, tolerability, and safety for the treatment of myopia.
The eye drop is designed to be administered nightly.
Wasn’t there just a study on this?
Sort of… the 2-year, randomized LAMP2 study assessed the use of 0.05% versus 0.01% atropine eye drops for delaying the onset of myopia in pediatric patients. See here for the findings.
Gotcha. What about this new study?
The 3-arm, randomized, multicenter, double-masked, placebo-controlled, phase 3 Childhood Atropine for Myopia Progression (CHAMP) study enrolled 576 pediatric patients (ages 3 to ≤ 17 years diagnosed with progressive myopia).
Two stages are included:
Stage 1 was a completed 3-year treatment period to evaluate the safety and efficacy of NVK002, after which enrolled patients were re-randomized for a masked
Stage 2 is an ongoing, randomized crossover 1-year treatment period to characterize cessation of therapy.
Patient criteria?
Study participants were required to be ages 3 to ≤ 17 years, with a spherical equivalent (SE) refraction of -0.5D to -6D and astigmatism no worse than -1.5D.
What were the dosages?
Patients were randomized 2:2:3 to receive either a once-daily placebo, NVK002 0.01%, or NVK002 0.02% eye drops for a 3-year period.
Responses were defined as a < 0.5D of myopia progression during the study.
Findings?
Both NVK002 0.01% and 0.02% illustrated a slow down in myopia progression.
However, investigators noted at 36 months, the 0.01% dose significantly increased the number of responders versus the placebo, as well as significantly decreased the mean SE refraction progression and axial elongation.
How did this compare to the 0.02% dosage?
While the 0.02% concentration also significantly slowed the mean axial elongation, it did not have a significant effect in increasing the proportion of responders.
Further, the dosage did not slow the mean SE refraction progression.
Any adverse events?
There were no reports of any serious adverse ocular events requiring treatment; non-ocular events were not related to the dosages.
Significance?
Study authors stated that, for the first time in a United States and European sample, the use of low-dose atropine has shown to have a significantly meaningful effect on myopia progressions.
They further said that, “NVK002 0.01% may offer the first approved pharmacological treatment option for myopia progression.”
What’s next?
According to Clinical Trials, the study is expected to be completed by August 2023. Vyluma may submit a new drug application (NDA) for NVK002 in the future.