You are here
Nevakar Completes Enrollment for its Phase III CHAMP Study of NVK-002
BRIDGEWATER, N.J., Sept. 11, 2019 /PRNewswire/ -- Nevakar Inc., a privately-held, late-stage specialty pharmaceutical company dedicated to developing innovative ophthalmic products, announced today that it has completed enrollment for its Phase III CHAMP (Childhood Atropine for Myopia Progression) study, evaluating the ability of NVK-002 to slow the progression of myopia in children. NVK-002 is a unique, proprietary, preservative-free, topical investigational therapy for patients aged 3 to 17 years.
The CHAMP trial builds upon prior ground-breaking studies conducted in Asia, which demonstrated the safety and efficacy of low doses of atropine and concluded that low-dose atropine slows the progression of myopia in children. The CHAMP study is a 576-subject, randomized, placebo-controlled, double-masked study evaluating the effects on myopia progression in children, with multiple study sites located in the United States and Europe. The study duration is 3 years, with an additional re-randomization for a 4th year of follow-up. Regulatory filing can take place after the 3-year endpoint has been reached. Management of Nevakar has held extensive discussions with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the protocol and study design and believes there is a clear path forward to regulatory submission in both the United States and in Europe. The CHAMP study represents the largest sponsored randomized controlled trial, to date, in myopia.
"Today marks the achievement of a key milestone in the development of NVK-002, which, if approved, would represent the first global pharmacologic treatment to slow the progression of myopia in children," stated Navneet Puri, PhD, founder, chairman and chief executive officer of Nevakar. "Pediatric myopia is a serious and irreversible condition for which there are currently no approved pharmacological treatments. The World Health Organization considers it to be a growing global epidemic that will affect roughly half the world's population, or approximately 2.5 billion people, by 2050. Left untreated, pediatric myopia can lead to significant vision loss and other eye complications later in life."
Raul Trillo, MD, MBA, Nevakar's chief commercial officer, added, "With the development of NVK-002, Nevakar has established a leadership position in the advancement of a novel pharmacological treatment for children with myopia and has built a runway to introduce additional, innovative ophthalmic products that address important unmet needs found in patients with other refractive disorders."
About Nevakar Inc.
Headquartered in Bridgewater, NJ and founded in 2015, Nevakar Inc. is a privately-held, fully integrated, late-stage specialty pharmaceutical company with an extensive pipeline focused on the development and commercialization of innovative products that address unmet medical needs. Nevakar utilizes the 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel, innovative and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information can be found at www.nevakar.com.
Chief Financial Officer
Managing Director, Rx Communications Group, LLC
SOURCE Nevakar Inc.