Novaliq Announces FDA Approval of VEVYE (Cyclosporine Ophthalmic Solution) 0.1% for the Treatment of the
Benzinga VEVYE is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks
Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved VEVYE (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE (development name CyclASol) is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment.
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Novaliq Announces FDA Approval of VEVYE (Cyclosporine Ophthalmic Solution) 0.1%, for the Treatment of the Signs and Symptoms of Dry Eye Disease (Photo: Business Wire)
"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 Krsser, 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."
