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Vyluma Announces Positive Results From Phase III CHAMP Study of NVK002 for Treatment of Myopia Progression in Children

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BRIDGEWATER, NJ, Oct. 27, 2022 (GLOBE NEWSWIRE) — Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, today announced top Phase III results CHAMP (clinical study of infant atropine for myopia progression). The analysis of this multicenter international study, carried out after three years of treatment and follow-up, demonstrates strong safety and efficacy of NVK002 as a potential treatment for the progression of myopia in children. The findings were shared today in an oral presentation at the American Academy of Optometry Annual Meeting in San Diego, California.

“CHAMP is the largest and longest prospective placebo-controlled pediatric myopia study conducted to date and we are very encouraged by the results from the first stage,” said Navneet Puri, PhD, Founder, President and CEO of the direction of Vyluma. “Myopia is a growing global epidemic that can have serious consequences for the vision of millions of children later in life, but there are currently no regulatory approved pharmaceutical treatments. As we perform analyzes of the data to assess the full results, the early results represent an important milestone in myopia management and signify a potential new and more promising era on the horizon.

Developed by Vyluma, NVK002 is a proprietary, experimental, low-dose, preservative-free atropine eye drop given nightly. NVK002 exploits 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 phase III, three-arm, randomized, double-blind, placebo-controlled clinical study in the United States and Europe of nearly 600 children and adolescents between the ages of three and seventeen at the time of enrollment. . The study consists of two stages: a full three-year treatment period to assess the safety and efficacy of NVK002, after which enrolled patients were re-randomized to a masked and continuous treatment period of one year to characterize the cessation of treatment.

NVK002 at a dose of 0.01% atropine achieved statistically significant and clinically significant differences from placebo in each key outcome, including responder analysis, mean change from baseline in refraction spherical equivalent (SER) and mean change from baseline in axial length at Month 36 NVK002 at 0.02% dose demonstrated efficacy at multiple time points, including a statistically significant mean change in axial length from baseline placebo at 36 months. Responder analysis was not statistically significant at month 36.

NVK002 at both doses demonstrated high safety and tolerability 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 in all treatment groups. The most common ocular adverse events were hyperemia, photophobia, allergic conjunctivitis, eye pruritus and eye irritation.

“Myopia is a serious condition that affects the vision of 30% of the world’s population today and is expected to affect approximately 5 billion people by 2050. The earlier myopia is treated, the better,” Karla said. Zadnik, OD, PhD, FAAO, Principal Investigator and Glenn A. Fry Professor of Optometry and Physiological Optics and Dean of The Ohio State University College of Optometry. “The CHAMP study shows us that Vyluma’s new low-dose atropine formulation can make a clinically meaningful difference in the treatment of children with myopia. This new evidence increases our scientific understanding of safe and effective ways to combat this growing global burden. »

Vyluma has partnered with Laboratoires Théa and Zhaoke Ophthalmology for the marketing of NVK002. Théa, the leading independent European pharmaceutical group in ophthalmology, will be responsible for the commercialization of NVK002 in Europe, as well as registration and commercialization in Canada, Mexico and certain 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 selected Southeast Asian countries (Brunei, Burma, Cambodia, Timor -Leste, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand and Vietnam).

“Vision correction with contact lenses and single vision glasses does not address the progression of myopia, 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 extensively studied in a large US and European population, in a well-controlled manner,” said Jean-Frédéric Chibret, President of Théa.

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

Vyluma expects 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 Progression of myopia in children. For more information on Vyluma and NVK002, please visit www.vyluma.com.

About Vyluma, Inc.Vyluma is a development-stage biopharmaceutical company focused on pharmaceutical treatments for refractive errors of the eye. Vyluma has a strong portfolio of assets in various stages of development that address significant unmet treatment needs for patients with refractive errors or eye pain. Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are also engaged in the development of products for the injectable markets. For more information, please visit www.vyluma.com.

About Nevakar Inc.Nevakar Inc. is a privately-held, commercial-stage, fully integrated biopharmaceutical company with an extensive product portfolio 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 patient quality of life and healthcare outcomes. Nevakar uses the 505(b)(2) regulatory pathway, along with its proven expertise in the development of new and proprietary sterile pharmaceutical products to identify, develop and obtain regulatory approval for its products. Additional information is available at www.nevakar.com.

About TheaThéa is the leading independent European pharmaceutical group in ophthalmology. Dedicated to eye care and a pioneer in the development of preservative-free care, Théa is the preferred partner of ophthalmologists in Europe thanks to the innovative and modern range of products it offers. Based in Clermont-Ferrand, France, it has thirty-five subsidiaries and offices in Europe, North and South America, North Africa and the Middle East. Today, its network has more than 1,600 employees and its products are available in 75 countries. Visit https://www.laboratoires-thea.com/en.

About Zhaoke OphthalmologyFounded 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 April 29, 2021. Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases both front and back. back of the eye. Many drugs are produced at 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, visit: www.zkoph.com.

About MyopiaMyopia is a serious and irreversible disease that causes loss of vision due to the elongation of the eyes. It is believed to be a growing global epidemic that will affect approximately half of the world’s population by 2050.1 The prevalence of myopia is accelerating due to increased exposure to close-up work on digital screens and reduced time outdoors, two factors that 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 diseases.4 Myopia progresses most rapidly between the ages of 5 and 15, when the eyes develop rapidly.5 Vision correction with single vision contact lenses and glasses do not slow the progression of myopia, leaving children at risk of serious consequences later in life.6,7,2

Media Contact:Theresa Masnik SHIFT Communications[email protected]

Investor contacts:Marshall WoodworthChief Financial Officer[email protected]

References

  1. Holden, BA, Fricke, TR, Wilson, DA, Jong, M., Naidoo, KS, Sankaridurg, P., Wong, TY, Naduvilath, TJ & Resnikoff, S. (2016). Global prevalence of myopia and high myopia and temporal trends from 2000 to 2050. Ophthalmology, 123(5), 1036-1042. https://doi.org/10.1016/j.ophtha.2016.01.006.
  2. Sankaridurg, P., Tahhan, N., Kandel, H., Naduvilath, T., Zou, H., Frick, KD, Marmamula, S., Friedman, DS, Lamoureux, E., Keeffe, J., Walline, JJ, Fricke, TR, Kovai, V., & Resnikoff, S. (2021). IMI impact of myopia. Investigative ophthalmology and visual sciences, 62(5), 2. https://doi.org/10.1167/iovs.62.5.2.
  3. Rusnak, S., Salcman, V., Hecova, L. and Kasl, Z. (2018). Risk of myopia progression: seasonal and lifestyle variations in axial length growth in Czech children. Journal of Ophthalmology, 2018, 1–5. https://doi.org/10.1155/2018/5076454.
  4. Ritchey, OED, PhD. (2020, September 18). Myopia increases the risk of serious sight-threatening eye disease. Review of myopia management. https://reviewofmm.com/myopia-increase-the-risk-of-serious-sight-mechanism-eye-disease/.
  5. Verkicharla, PK, Kammari, P., & Das, AV (2020). The progression of myopia varies with age and severity of myopia. PLOS ONE, 15(11), e0241759. https://doi.org/10.1371/journal.pone.0241759.
  6. Deere, K., Williams, C., Leary, S., Mattocks, C., Ness, A., Blair, SN and Riddoch, C. (2009). Myopia and subsequent physical activity in adolescence: a prospective study. British Journal of Sports Medicine, 43(7), 542–544. https://doi.org/10.1136/bjsm.2008.049288.
  7. Wolffsohn, JS, Jong, M., Smith, EL, Resnikoff, SR, Jonas, JB, Logan, NS, Morgan, I., Sankaridurg, P. and Ohno-Matsui, K. (2021). IMI 2021 Reports and Summary – Reflections on Implications for Clinical Practice. Investigative ophthalmology and visual sciences, 62(5), 1. https://doi.org/10.1167/iovs.62.5.1.

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Source: Vyluma, Inc.

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