BRIDGEWATER, N.J.—Vyluma, Inc., a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced positive top-line results from its Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study. Analysis of the multi-center, international study, performed after three years of treatment and follow-up, demonstrates strong safety and efficacy for NVK002, a low dose, preservative-free atropine eye drop, as a potential treatment for the progression of myopia in children, according to Vyluma which shared the results last week at the American Academy of Optometry annual meeting in San Diego, Calif.

Based on the results of the study, Vyluma plans to submit a New Drug Application for NVK002 to the U.S. Food and Drug Administration (FDA) as early as Q1 2023. If approved by the FDA, NVK002 would become the first FDA-approved atropine in the U.S. to slow the progression of myopia. Currently, atropine is only available off-label and compounded. To date, just two treatments for myopia management—CooperVision's MiSight and Johnson & Johnson Vision's Acuvue Abiliti—have been approved by the FDA.

“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,” said Navneet Puri, PhD, founder, chairman and CEO of Vyluma. “Myopia is a growing global epidemic that can have serious consequences for the vision of millions of children later in life, yet there are no currently available, regulatory approved pharmaceutical treatments. 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.”

CHAMP is a three-arm, randomized, double-masked, placebo-controlled Phase III clinical study conducted across the U.S. and Europe in nearly 600 children and adolescents aged 3 to 17 years at enrollment. NVK002 at a dose of 0.02% demonstrated efficacy at several time points across a 36-month period, including a statistically significant mean change in axial length compared to placebo at 36 months. The most common ocular adverse events were hyperemia, photophobia, allergic conjunctivitis, eye pruritis and eye irritation.

“The CHAMP study shows us that Vyluma’s novel formulation of low-dose atropine can make a clinically meaningful difference in treating children with myopia. This new evidence increases our scientific understanding of the safe and effective ways we can tackle this growing global burden,” said Karla Zadnik, OD, PhD, FAAO, lead investigator and Glenn A. Fry professor of Optometry and Physiological Optics and dean at The Ohio State University College of Optometry.

Vyluma has partnered with Laboratories Théa and Zhaoke Ophthalmology for commercialization of NVK002. Théa, the leading independent European pharmaceutical group in ophthalmology, will be responsible for the commercialization of NVK002 in Europe, and for the registration and commercialization in Canada, Mexico and selected South American countries.

Zhaoke Ophthalmology, a leading ophthalmic pharmaceutical company, will be responsible for the clinical development and commercialization of NVK002 in Greater China, South Korea, and certain select countries in Southeast Asia.