Vyluma announced topline results from its phase 3 CHAMP (Childhood Atropine for Myopia Progression) clinical study. Analysis of this multicenter, international study, performed after 3 years of treatment and follow up, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children, according to Vyluma. The results were shared in an oral presentation at the American Academy of Optometry annual meeting in San Diego, CA.

“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 Chief Executive Officer, 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.”

Developed by Vyluma, NVK002 is a proprietary, investigational, low-dose, preservative-free atropine eye drop administered nightly. NVK002 leverages what is known about a well-characterized therapeutic agent, atropine, in a new low-dose, preservative-free formulation to help address the urgent need for pharmacological control of myopia. CHAMP is a three-arm, randomized, double-masked, placebo-controlled phase 3 clinical study conducted across the U.S. and Europe in nearly 600 children and adolescents aged 3 to 17 years at enrollment. 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.

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 (SER), and mean change from baseline in axial length at month 36. NVK002 at a dose of 0.02% demonstrated efficacy at several time points, including a statistically significant mean change in axial length compared to placebo at 36 months. Responder analysis was not statistically significant at month 36.

NVK002 at both doses demonstrated strong safety and tolerability which were comparable to placebo. There were no ocular serious adverse events (SAEs) and the incidences of non-ocular SAEs and discontinuations due to non-ocular SAEs were similar across treatment groups. The most common ocular adverse events were hyperemia, photophobia, allergic conjunctivitis, eye pruritis, and eye irritation.

“Myopia is a serious condition that impacts the vision of 30% of the world’s population today and is expected to impact an estimated 5 billion people by 2050. The earlier myopia is addressed, the better,”[1,2] 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. “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.”

Vyluma has partnered with Laboratories Théa and Zhaoke Ophthalmology for commercialization of NVK002. Théa, an independent European pharmaceutical group, 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 will be responsible for the clinical development and commercialization of NVK002 in Greater China, South Korea, and certain select countries in Southeast Asia (Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam).

“Vision correction with single vision contact lenses and eyeglasses does not treat myopia progression, leaving children at risk of serious consequences later in life, so there is a clear unmet need. The CHAMP study is the first time that low-dose atropine has been studied extensively in a large U.S. and European population, in a well-controlled manner,” said Jean-Frédéric Chibret, President, Théa.

“In China, hundreds of millions of children and adolescents suffer from myopia. We are excited by the encouraging data in the U.S. and Europe. This adds to the evidence for the NVK002 NDA submission to the Chinese regulator. Our intention is to bring this drug to market as soon as possible and these results take us one step closer in our mission to transform visual health in China,” said Dr. Li Xiaoyi (Benjamin), Chairman of the Board of Directors, Executive Director and CEO, Zhaoke Ophthalmology.

Vyluma plans to submit a new drug application for NVK002 to the FDA as early as Q1 2023. If approved by the FDA, NVK002 would be a first-in-class, clinically proven pharmaceutical agent for the treatment of myopia progression in children. For more information about Vyluma and NVK002, please visit www.vyluma.com.

References

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