NVK002 is currently under FDA review, with a PDUFA date scheduled for January 31, 2024.
Vyluma Inc announced positive top-line results from the second stage of its Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study of its lead compound, NVK002 (low dose atropine 0.01%), a proprietary, investigational, preservative-free eye drop administered nightly and intended for patients ages 3 to 17.
According to a company news release, an analysis of the results of this multi-center, international study conducted after 4 years of treatment and follow up, demonstrated strong safety, the absence of rebound upon washout of the study drug, and continued efficacy for NVK002 as a potential treatment for myopia in children.
Navneet Puri, PhD, the company’s founder and chairman, noted in a company news release NVK002 currently is under FDA review with a Prescription Drug User Fee Act (PDUFA) date of January 31, 2024 set.
“With the completion of the second and final phase of CHAMP, Vyluma continues its progress towards bringing NVK002 forward as an important new, first-in-class pharmaceutical treatment option for children with myopia,” Puri added in the statement.
The company noted in its news release that during the 4th year of the study, both doses of NVK002 -- the 0.01% and 0.02% concentrations -- continued to exhibit a strong safety profile with a low level (8% incidence) of Treatment Emergent Adverse Events (TAES) and no evidence of meaningful rebound in subjects who had discontinued active treatment and were washed out over one year.
Moreover, in year 4, NVK002 0.01% data indicate a continued expansion of the previously reported treatment effect1 in both the mean change from baseline in Spherical Equivalent Refraction (SER) and mean change from baseline in axial length endpoints when compared to a matched historical placebo group. There was no evidence of tachyphylaxis in the treatment effect after 4 years, according to the news release.
CHAMP was a 3-arm, randomized, double-masked, placebo-controlled Phase III clinical study conducted across the US and Europe in nearly 600 children and adolescents aged 3 to 17 years at enrollment. The study consisted of 2 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.2
“CHAMP is the largest and longest placebo-controlled, prospective pediatric myopia study conducted to date and we are very encouraged by the results from the first stage. While we are conducting analyses of the data to assess the full results, the top-line results represent a significant landmark in myopia management and signify a potential new and more hopeful era on the horizon,” said Puri when results were announced from the trial back in 2022