Water-Free Dry Eye Disease Therapy Vevye Gets FDA Approval

The 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 contains cyclosporine, a calcineurin inhibitor. According to Novaliq, the drug’s bioavailability is improved using its proprietary water-free technology. The product does not contain oils or surfactants and is preservative-free.

The approval was based on data from multiple clinical studies, including 2 multicenter, randomized, adequate and well-controlled studies (ClinicalTrials.gov Identifier: NCT02617667 [CYS-002] and NCT04523129 [CYS-004]). Efficacy and safety were evaluated in 1369 patients with dry eye disease, of which 738 participants received Vevye.

In both studies, a statistically significantly greater percentage of patients treated with Vevye had increases of 10mm or greater from baseline in Schirmer tear test score compared with vehicle (CYS-002: difference, 7.8% [95% CI, 0.5-15]; P =.04; CYS-004: difference, 3.9% [95% CI, 0.02-7.8]; P =.05). The most common adverse reactions reported were instillation reactions, which were mostly mild in severity.

“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 supplied as a 5mL multiple-dose eye drop bottle containing 2mL of solution. Each drop (0.01mL) delivers 0.01 mg of cyclosporine.