Preliminary data from landmark, three-year, international study demonstrate safety and efficacy of NVK002 as a potential treatment for the progression of myopia in children
Bridgewater, NJ – October 27, 2022 – Vyluma, Inc (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, today announced top-line results from its Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study. Analysis of this multi-center, international study, performed after three years of treatment and follow up, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children. The results were shared today 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 III clinical study conducted across the U.S. and Europe in nearly 600 children and adolescents aged three to seventeen years at enrollment. The study consists of two stages: a completed three-year treatment period to evaluate the safety and efficacy of NVK002, after which enrolled patients were re-randomized for a masked, ongoing one-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, 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 (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 U.S. Food and Drug Administration (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.
About Vyluma, Inc.
Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma has a robust pipeline of assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain. Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are also engaged in developing products for the injectable markets. For additional information please visit www.vyluma.com.
About Nevakar Inc.
Nevakar Inc. is a fully integrated privately held, commercial-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater, New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patients’ quality of life and healthcare outcomes. Nevakar utilizes the 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at www.nevakar.com.
Théa is the leading independent European pharmaceutical group in ophthalmology. Dedicated to eye care and a pioneer in the development of preservative-free treatments, Théa is the preferred partner of ophthalmologists in Europe due to the innovative and modern range of products it offers. Based in Clermont-Ferrand, France, it has thirty-five affiliates and offices in Europe, North and South America, North Africa, and the Middle East. Today, its network includes more than 1,600 employees, and its products are available in 75 countries, visit https://www.laboratoires-thea.com/en.
About Zhaoke Ophthalmology
Founded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs. The company was listed on the Main Board of the Hong Kong Stock Exchange on 29 April 2021. Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou. Zhaoke Ophthalmology’s goal is to become a leader in ophthalmology in the world. For more information, please visit: www.zkoph.com.
Myopia is a serious and irreversible condition that causes loss of vision due to eye elongation. It is considered to be a growing global epidemic that will affect roughly half the world’s population by 2050.1 Myopia prevalence is accelerating because of increased exposure to close work on digital screens and reduced time outdoors, both of which have been exacerbated by COVID-19.3 If left untreated, childhood myopia increases the risk of vision loss and eye complications later in life, due to cataracts, glaucoma and retinal disease.4 Myopia progresses most rapidly between the ages of 5 and 15 when eyes are developing quickly.5 Vision correction with single vision contact lenses and spectacles does not slow myopia progression, leaving children at risk of serious consequences later in life.6,7,2
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