Multiyear study shows potential of low-dose atropine for myopia control
SAN DIEGO — Preliminary data from a 3-year, phase 3 clinical trial of Vyluma’s NVK002 supported its safety and efficacy as a potential treatment for myopia progression in children, according to a press release from the company.
Vyluma founder, chairman and CEO Navneet Puri, PhD, stated in a virtual press conference during Academy 2022 that NVK002 “has been shown to be safe and effective in a multiyear clinical trial in kids 3 to 17 years old in the U.S. and Europe. This would be the first-in-class clinically proven pharmaceutical treatment for myopia progression in children, if approved.”
NVK002 is a proprietary, investigational, preservative-free atropine 0.01% drop administered nightly, the company said in a press release.
The drop was evaluated in CHAMP, a three-arm, randomized, double-masked, placebo-controlled phase 3 clinical study involving 600 children. The trial consists of two stages: a 3-year treatment period for evaluating NVK002 safety and efficacy, after which the participants were re-randomized for a masked, ongoing 1-year treatment period to characterize cessation of therapy, according to the release.
“We have achieved our primary objective of successful treatment of myopia progression in children,” Puri said during the academy-sponsored press conference.
“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,” Puri added in the press release.
The 0.01% atropine achieved “statistically significant and clinically meaningful differences from placebo” in all key outcome measures, according to the release, including responder analysis, mean change from baseline in spherical equivalent refraction and mean change of axial length at 36 months.
NVK002 at a dose of 0.02% showed efficacy at several time points, including a statistically significant mean change in axial length compared with placebo at 36 months, the company stated. Responder analysis, however, was not statistically significant at month 36.
Participants experienced no serious ocular adverse events, and the rate of treatment discontinuation was similar among those taking both doses. The most common ocular adverse events were hyperemia, photophobia, allergic conjunctivitis, eye pruritis and eye irritation.
Puri said during the press conference that Vyluma’s mission “is to preserve the vision of children and adults worldwide.”
He noted there have been questions about atropine concentration and safety of long-term treatment.
“NVK002 leverages the benefits of a known compound in low-dose, preservative-free concentration,” he said.
“We are making significant progress on our commitment to address the myopia epidemic,” Puri continued. “We plan to submit a new drug application to the FDA in the coming months.”
Vyluma has partnered with Laboratories Théa and Zhaoke Ophthalmology for commercialization of NVK002, the company said in the release.
Reference:
- Vyluma announces positive results from phase 3 CHAMP study of NVK002 for treatment of myopia progression in children. https://vyluma.com/press_release/vyluma-announces-positive-results-from-phase-3-champ-study-of-nvk002-for-treatment-of-myopia-progression-in-children/. Published Oct. 27, 2022. Accessed Oct. 27, 2022.
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