“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
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
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
Vyluma has partnered with Laboratories Théa and
“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
“In China, hundreds of millions of children and adolescents suffer from myopia. We are excited by the encouraging data in the
Vyluma plans to submit a New Drug Application for NVK002 to the
About
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
About
About Théa
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
About
Founded in 2017,
About Myopia
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
Media Contact:
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Investor Contact:
Chief Financial Officer
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References
- Holden, B. A., Fricke, T. R., Wilson, D. A., Jong, M., Naidoo, K. S., Sankaridurg, P., Wong, T. Y., Naduvilath, T. J., & Resnikoff, S. (2016). Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology, 123(5), 1036–1042. https://doi.org/10.1016/j.ophtha.2016.01.006.
- Sankaridurg, P., Tahhan, N.,
Kandel , H., Naduvilath, T., Zou, H., Frick, K. D., Marmamula, S., Friedman, D. S., Lamoureux, E., Keeffe, J., Walline, J. J., Fricke, T. R., Kovai, V., & Resnikoff, S. (2021). IMI Impact of Myopia. Investigative Opthalmology & Visual Science, 62(5), 2. https://doi.org/10.1167/iovs.62.5.2. - Rusnak, S., Salcman, V., Hecova, L., & Kasl, Z. (2018). Myopia Progression Risk: Seasonal and Lifestyle Variations in Axial Length Growth in Czech Children.
Journal of Ophthalmology , 2018, 1–5. https://doi.org/10.1155/2018/5076454. - Ritchey, O. E. D., 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-threatening-eye-disease/. - Verkicharla, P. K., Kammari, P., & Das, A. V. (2020). Myopia progression varies with age and severity of myopia. PLOS ONE, 15(11), e0241759. https://doi.org/10.1371/journal.pone.0241759.
Deere , K., Williams, C., Leary, S., Mattocks, C., Ness, A., Blair, S. N., &Riddoch , C. (2009). Myopia and later physical activity in adolescence: a prospective study.British Journal of Sports Medicine , 43(7), 542–544. https://doi.org/10.1136/bjsm.2008.049288.- Wolffsohn, J. S., Jong, M., Smith, E. L., Resnikoff, S. R., Jonas, J. B., Logan, N. S., Morgan, I., Sankaridurg, P., & Ohno-Matsui, K. (2021). IMI 2021 Reports and Digest – Reflections on the Implications for Clinical Practice. Investigative Opthalmology & Visual Science, 62(5), 1. https://doi.org/10.1167/iovs.62.5.1.
Source:
2022 GlobeNewswire, Inc., source