Vyluma just announced results from its phase 3 CHAMP (Childhood Atropine for Myopia Progression) trial.
What is the CHAMP trial?
CHAMP is a phase 3 clinical study conducted across the United States and Europe in nearly 600 children and adolescents between the ages of 3 and 17 years. The study consists of two stages: a completed 3-year treatment period to evaluate the safety and efficacy of NVK002, after which enrolled patients were re-randomized for a masked, ongoing 1-year treatment period to characterize cessation of therapy.
What is NVK002?
NVK002 is a proprietary, investigational, low-dose, preservative-free atropine eye drop administered nightly.
What percentage of atropine is being tested in this trial?
There are two different doses: 0.01% and 0.02%.
NVK002 at a dose of 0.01% atropine achieved statistically significant and clinically meaningful differences from placebo in every key outcome measure, including responder analysis, mean change from baseline in spherical equivalent refraction, and mean change from baseline in axial length at month 36. NVK002 at a dose of 0.02% demonstrated efficacy at several timepoints, including a statistically significant mean change in axial length compared to placebo at 36 months.
NVK002 at both doses demonstrated strong safety and tolerability, which were comparable to placebo.
When might we be able to prescribe this?
If all goes well with the FDA, NVK002 might be available by 2024. Vyluma plans to submit an NDA for the drop as early as Q1 2023. (via)
WHAT YOUR PATIENT MIGHT ASK YOU.
How do you diagnose AMD?
An online poll of more than 2,000 respondents found that 61% of Americans did not know that AMD is diagnosed through a dilated eye exam.
How important is vision to these participants?
Of the individuals polled, 81% would be willing to give up one of the following if it meant never losing their eyesight: going on vacation, $1 million, the internet, listening to music, the ability to remember people's names, or one of their other senses. (via)