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.
Investor Contacts:
Marshall Woodworth
Nevakar Inc.
Chief Financial Officer
(908) 367-7413
Media:
Paula Schwartz
Managing Director, Rx Communications Group, LLC
(917) 322-2216
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SOURCE Nevakar Inc.