BRIDGEWATER, N. J., Oct. 27, 2022 (GLOBE NEWSWIRE) — Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets with regard to the treatment of refractive errors, today announced top-line results from its Stage III CHAMPION (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 plus efficacy regarding NVK002 as a potential treatment for the progression associated with myopia in children. The results were shared today in an oral presentation at the American Academy of Optometry annual meeting within 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 comes 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 that vision of millions of children later in life, yet there are no currently available, regulatory approved pharmaceutical treatments. While we are usually conducting analyses of the data to assess the full results, the top-line results represent a significant landmark within myopia management and signify a possible new and more hopeful era on the horizon. ”

Developed by Vyluma, NVK002 is the 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 intended 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 kids and adolescents aged 3 to seventeen years in enrollment. The study consists associated with two stages: a completed three-year treatment period in order to evaluate the particular safety plus efficacy of NVK002, after which enrolled patients were re-randomized for the masked, ongoing one-year therapy period to characterize cessation of therapy.

NVK002 from 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 through baseline within axial length at month 36. NVK002 at a dose of 0. 02% demonstrated efficacy with several time points, which includes a statistically significant imply change in axial size compared to placebo at 36 months. Responder analysis was not statistically significant at 30 days 36.

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

“Myopia is really a serious condition that impacts the eyesight of 30% of the world’s population today and is expected to impact an estimated 5 billion people simply by 2050. The earlier myopia will be addressed, the better, ” ^{1, 2} said Karla Zadnik, OD, PhD, FAAO, lead investigator and Glenn A. Fry Professor associated with Optometry plus 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 particular 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 pharmaceutic group within ophthalmology, will be responsible to get the commercialization of NVK002 in European countries, and for the particular registration plus commercialization in Canada, Mexico, and selected South United states countries. Zhaoke Ophthalmology, a leading ophthalmic pharmaceutical organization, will be responsible for the clinical development and commercialization of NVK002 in Greater China, South Korea, and certain select countries within Southeast Asia (Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the particular Philippines, Singapore, Thailand, plus Vietnam).

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

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

Vyluma plans to submit a New Drug Application pertaining to NVK002 to the Oughout. 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 development in children. For more information about Vyluma and NVK002, please visit www.vyluma.com .

About Vyluma, Inc.
Vyluma is the development-stage biopharmaceutical company along with a focus on pharmaceutic treatments meant for refractive mistakes of the vision. Vyluma has a robust pipeline associated with assets in various stages of development which address important unmet therapy needs associated with patients with refractive errors or attention pain. Vyluma itself is a subsidiary of Nevakar Incorporation., a holding company whose subsidiaries are also engaged in developing products for that injectable markets. For additional information please visit www.vyluma.com .

About Nevakar Inc.
Nevakar Incorporation. is a fully integrated privately held, commercial-stage biopharmaceutical business with an extensive portfolio of items within 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 tackle unmet medical needs, thereby improving patients’ quality of life plus healthcare outcomes. Nevakar utilizes the 505(b)(2) regulatory pathway, along with its proven expertise in the advancement of book and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for the products. Additional information is available at www.nevakar.com .

About Théa
Théa is the leading impartial European pharmaceutic group within ophthalmology. Dedicated to eye care and a pioneer in the development of preservative-free treatments, Théa may be the preferred partner of ophthalmologists in Europe due in order to the innovative and modern range associated with products it offers. Based in Clermont-Ferrand, France, it offers thirty-five affiliates and offices in European countries, North and South America, North Africa, plus 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
Started in 2017, Zhaoke Ophthalmology (SEHK: 6622) is the leading ophthalmic pharmaceutical firm dedicated to the particular research and development, manufacturing and commercialization of therapies that deal with significant unmet medical needs. The company was listed on the Main Table from the Hong Kong Stock Exchange on 29 April 2021. Zhaoke Ophthalmology has a comprehensive medication portfolio of innovative plus generic remedies covering six major eyesight diseases across both the front and back of the eyes. Many of the drugs are being produced in its state-of-the-art and fully functional development plus production facility in Nansha, Guangzhou. Zhaoke Ophthalmology’s goal is to become a leader in ophthalmology in the particular world. To find out more, please check out: www.zkoph.com .

Regarding Myopia
Myopia is a serious and irreversible condition that causes loss of vision because of eye elongation. It is definitely considered to be the growing global epidemic that will affect roughly half the world’s populace by 2050. ¹ Myopia prevalence is accelerating because associated with 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 particular risk associated with 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 building quickly. ⁵ Vision correction along with single eyesight disposable lenses plus spectacles will not slow myopia progression, leaving kids at danger of serious consequences later on. ^{6, 7 , two}

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References

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