Multi-center, international clinical study designed to assess the safety and efficacy of novel investigational low-dose atropine eye drops in children 3-17 years old with myopia
Bridgewater, NJ – September 1, 2022 – Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced today that the last patient visit has been completed for the primary analysis of the pivotal Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study. The CHAMP study has been designed, in collaboration with FDA, to evaluate whether NVK002 eye drops are safe and effective as a treatment for the progression of myopia in children. With this milestone, Vyluma remains on track for primary analysis readout later this year and regulatory submission in 2023. NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly, which, if approved, would be the first-in-class pharmaceutical treatment for myopia progression in children.
The CHAMP clinical study, conducted in multiple centers across the U.S. and Europe, follows ground- breaking studies conducted in Asia which concluded that low doses of atropine could be used to slow the progression of myopia in children. CHAMP is a three-arm, randomized, double-masked, placebo- controlled, Phase III study consisting of two stages: a three-year study period to evaluate the safety and efficacy of NVK002, followed by a re-randomized, masked, one-year study period to characterize cessation of therapy.
“This milestone brings us very close to the end of this important first stage of the Phase III CHAMP study,” said Navneet Puri, PhD, Founder, Chairman and Chief Executive Officer, Vyluma. “We look forward to sharing the results soon. In the meantime, we remain committed to following the science in the hope that, with these new data, NVK002 could hold the key to a potential first-ever clinically proven and approved pharmaceutical treatment option for children with myopia.”
Myopia, a serious and irreversible condition, is a growing global epidemic that will affect roughly half the world’s population by 2050.1 If left untreated, childhood myopia increases the risk of vision loss and eye complications later in life due to cataracts, glaucoma, and retinal disease.2 Myopia progresses most rapidly between the ages of 5 and 15 when eyes are developing quickly.3
“Myopia prevalence is accelerating among children because of increased exposure to close work on digital screens and reduced time outdoors,” explained Eric Lang, MD, Chief Medical Officer, Vyluma. “Vision correction with single vision contact lenses and eyeglasses does not treat myopia progression, leaving children at risk of serious consequences later in life. After almost five years, we now stand on the all-important cusp of the conclusion of the first stage of the CHAMP study. This represents a momentous landmark – bringing NVK002 a critical step closer to its potential in addressing this increasingly critical global unmet need.”
About Vyluma, Inc.
Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma’s pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to treat the progression of myopia in children. NVK002 is currently in late Phase III clinical development in the United States, Europe, and Asia.
Vyluma has a robust pipeline of other 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 engaged in developing products for the ophthalmic and 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.
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Vekicharla PK, Kammar P, Das AV. Myopiaprogression varies with age and severity of myopia. PLoS ONE. 2020;15(11): e0241759.