The multi-center, international clinical study is designed to assess the safety and efficacy of novel investigational low-dose atropine eye drops in children 3-17 years old with myopia.
Vyluma Inc. today announced that the last patient visit has been completed for the primary analysis of the pivotal Phase III Childhood Atropine for Myopia Progression (CHAMP) clinical study.
The CHAMP study has been designed, in collaboration with FDA, to evaluate whether NVK002 eye drops are safe and effective as a treatment for the progression of myopia in children.
With this milestone, Vyluma remains on track for primary analysis readout later this year and regulatory submission in 2023. NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly, which, if approved, would be the first-in-class pharmaceutical treatment for myopia progression in children.
According to a news release, the CHAMP clinical study, conducted in multiple centers across the United States and Europe, follows ground-breaking studies conducted in Asia which concluded that low doses of atropine could be used to slow the progression of myopia in children.
CHAMP is a three-arm, randomly assigned, double-masked, placebo-controlled, Phase III study consisting of two stages: a three-year study period to evaluate the safety and efficacy of NVK002, followed by a re-randomized, masked, one-year study period to characterize cessation of therapy.
“This milestone brings us very close to the end of this important first stage of the Phase III CHAMP study,” Navneet Puri, PhD, founder, chairman and CEO of Vyluma, said in a statement. “We look forward to sharing the results soon. In the meantime, we remain committed to following the science in the hope that, with these new data, NVK002 could hold the key to a potential first-ever clinically proven and approved pharmaceutical treatment option for children with myopia.”
Myopia, a serious and irreversible condition, is a growing global epidemic that will affect roughly half the world’s population by 2050.1 If left untreated, childhood myopia increases the risk of vision loss and eye complications later in life due to cataracts, glaucoma, and retinal disease.2 Myopia progresses most rapidly between the ages of 5 and 15 when eyes are developing quickly.3
Eric Lang, MD, chief medical officer of Vyluma, pointed out in a news release that myopia prevalence is accelerating among children because of increased exposure to close work on digital screens and reduced time outdoors.
“Vision correction with single vision contact lenses and eyeglasses does not treat myopia progression, leaving children at risk of serious consequences later in life,” Lang said in a statement. “After almost 5 years, we now stand on the all-important cusp of the conclusion of the first stage of the CHAMP study. This represents a momentous landmark – bringing NVK002 a critical step closer to its potential in addressing this increasingly critical global unmet need.”