FDA Approves Novel Cyclosporine for Dry Eye Disease

The FDA has approved Novaliq’s Vevye (cyclosporine) 0.1% to treat patients with dry eye disease. Vevye (which had development name CyclASol) is a water-free, preservative-free solution based on EyeSol technology. Cyclosporine is not water-soluble, but the EyeSol excipient perfluorobutylpentane allows for improved bioavailability and better efficacy on the target tissue. The product contains no oils, no surfactants and is preservative-free due to the novel carrier.

Dry eye is one of the most common ocular surface disorders, with about 18 million Americans diagnosed with dry eye disease. Inflammation and immunologic processes play a key role in the pathology of the disease.

John D. Sheppard, M.D.

“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,” John D. Sheppard, M.D., 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, said in a press release.

Novaliq submitted its NDA in August 2022, and the application was based on two pivotal studies in more than 2,000 patients. The trials that showed Vevye delivered a fast onset of therapeutic effect, clinical meaningful improvement of ocular surface damage, and tolerability. Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining (tCFS) score favoring Vevye in both studies at days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement.

Related: Bausch + Lomb Exec Discusses Novel Dry Eye Disease Treatment

Additionally, last month, Novaliq and development partner Bausch + Lomb announced the FDA approval for a different dry therapy: Miebo (perfluorohexyloctane; formerly known as NOV03). Miebo is the first treatment for dry eye that directly targets tear evaporation. A leading cause of DED is excessive tear evaporation, which due to an altered tear lipid layer, is often associated with the clinical signs of Meibomian gland dysfunction (MGD).

Company executives said Miebo will be available in the second half of 2023.

This approval was based on two pivotal phase 3 trials, (GOBI and MOJAVE), both of which demonstrated statistically significant improvement vs. control for both primary and key secondary sign and symptom endpoints as early as day 15 and through day 57. Miebo was well tolerated in both studies.