FDA Approves Novaliq's Cyclosporine Eye Drop Vevye for Treatment of Dry Eye Disease

Just 3 weeks after receiving FDA approval for dry eye drug Miebo, Novaliq has received FDA approval for Vevye (cyclosporine ophthalmic solution; formerly known as CyclASol) 0.1% for the treatment of the signs and symptoms of dry eye disease. Novaliq says 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 of treatment.

“We are proud that FDA approved Vevye. The safety and efficacy of Vevye were assessed in a total of 1,369 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,” Sonja Krösser, PhD, Vice President Medical Science & Regulatory Affairs at Novaliq, said in a company news release. “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 designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy, according to Novaliq. The solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity.

"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.”

The NDA was supported by safety and efficacy results in over 1,000 patients with DED from a phase 2 dose finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study, and its open label extension study. CyclASol has demonstrated in two independent adequate and well-controlled, multicenter studies (ESSENCE-1 and ESSENCE-2) clinically meaningful and statistically significant improvements in the indication.

Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining (tCFS) score favoring CyclASol in both studies at Days 15 and 29. Up to 71.6% of patients responded within 4 weeks with a clinically meaningful improvement of ≥ 3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies.

In both studies, compared to vehicle at the end of treatment, there was a statistically significant (P<0.05) higher percentage of patients with increases of 10 mm from baseline in Schirmer’s tear test score at Day 85 and Day 29, respectively, confirming a known effect of the active ingredient cyclosporine. 

The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. 

“The US FDA approval of Vevye marks a milestone for patients and care takers by addressing a significant unmet need for millions of people suffering with this disease,” said Christian Roesky, PhD, CEO Novaliq. “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 on our mission to transform ocular therapies by developing breakthrough novel EyeSol therapies way beyond dry eye disease.”

Click here for full Prescribing Information for Vevye.

The approval of Vevye comes just 3 weeks after the FDA approved Miebo (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) for the treatment of the signs and symptoms of dry eye disease (DED). Miebo was developed by Novaliq and Bausch + Lomb. The companies said Miebo is the first and only FDA-approved treatment for DED that directly targets tear evaporation.