Novaliq GmbH has received approval from the U.S. Food and Drug Administration (FDA) for VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of signs and symptoms of dry eye disease.
VEVYE™ (development name CyclASol®) is the first and only cyclosporine solution that has shown efficacy in alleviating dry eye disease after a 4-week treatment period.
“We are proud that FDA approved VEVYE. The safety and efficacy of VEVYE were assessed in a total of 1369 patients with dry eye disease, of which 738 received VEVYE. VEVYE and its novel vehicle were safe, well tolerated, and demonstrated early, consistent, and durable therapeutic effects,” said Sonja Krösser, PhD, Vice President Medical Science & Regulatory Affairs at Novaliq. “It is an exciting moment when you have followed science that finally led into a new category of water-free ocular therapies addressing unmet medical needs for patients suffering from dry eye disease.”
VEVYE is cyclosporine, solubilized in a novel, water-free excipient and was specifically developed to meet unfulfilled requirements, offering patients a rapidly effective and well-tolerated treatment for dry eye. The solution is free from water, antimicrobial preservatives, oils, and surfactants. Being a water-free product, it does not possess pH or osmolarity characteristics.
"VEVYE addresses the well documented underlying inflammatory root cause of dry eye disease, repeatedly demonstrating early and clinically meaningful efficacy upon both signs and symptoms,” said John D. Sheppard, MD, MMSc, FACS, professor of ophthalmology at Eastern Virginia Medical School, and Mid-Atlantic Medical Director for Eye Care Partners and investigator in the development program.
“The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis. VEVYE is an exceptionally well tolerated formulation, combining a novel, first-in-class vehicular delivery system with by far the most established and safe topical active pharmaceutical ingredient, cyclosporine, providing a major advancement for our patients,” John D. Sheppard added.
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