VEVYE, whose development name is CyclASol, is said to be the first and only cyclosporine solution indicated to treat dry eye disease with efficacy shown after four weeks of treatment
VEVYE is intended to treat signs and symptoms of dry eye disease. (Credit: Business Wire/Novaliq GmbH)
Biopharmaceutical company Novaliq announced that its VEVYE (cyclosporine ophthalmic solution) 0.1% has received approval from the US Food and Drug Administration (FDA) to treat signs and symptoms of dry eye disease.
VEVYE, whose development name is CyclASol, is said to be the first and only cyclosporine solution indicated to treat dry eye disease with efficacy shown after four weeks of treatment.
Novaliq CEO Christian Roesky said: “The US FDA approval of VEVYE marks a milestone for patients and caretakers by addressing a significant unmet need for millions of people suffering from this disease.
“With now two EyeSol-based and water-free dry eye drug therapies approved by FDA Novaliq has established a novel category of non-aqueous, non-preserved ophthalmic drugs with the opportunity to become a standard of care in ophthalmology in the future.
“We will continue to execute our mission to transform ocular therapies by developing breakthrough novel EyeSol therapies way beyond dry eye disease.”
Designed to address unmet needs, the ophthalmic solution is cyclosporine, solubilised in a water-free excipient. It provides patients with fast-acting and well-tolerable dry-eye drug therapy.
According to Germany-based Novaliq, the solution does not contain water or anti-microbial preservatives, oils, or surfactants. So, there is no associated pH and no osmolarity.
Novaliq Medical Science & Regulatory Affairs VP Sonja Krösser said: “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.
“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.”