Novaliq Submits NDA for Dry Eye Treatment

Novaliq has submitted a new drug application (NDA) to the FDA for CyclASol (cyclosporine ophthalmic solution) to treat patients dry eye disease (DED). CyclASol is a preservative-free, water-free, anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine. While it is not water-soluble, cyclosporine can be soluble in the excipient perfluorobutylpentane using Novaliq’s EyeSol technology. The technology allows for improved bioavailability and better efficacy.

Christian Roesky, Ph.D.

“This is the first submission of a novel product category of water-free, topical drug therapies utilizing EyeSol as a drug carrier,” Christian Roesky, Ph.D., chief executive officer of Novaliq, said in a press release.

The NDA is supported by safety and efficacy results in more than 1,000 patients with dry eye disease 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. In ESSENCE-1 and ESSENCE-2, the effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining score favoring CyclASol in both studies at days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement. Responders showed also statistically significant improvements in a variety of symptoms compared with non-responders at day 29.

Data were presented at the American Cataract and Refractive Surgery (ASCRS) annual meeting in Washington D.C., in April 2022.

Head-to-head data versus AbbVie’s Restasis (cyclosporine) from the phase 2 study suggest that CyclASol has a stronger and faster therapeutic effect on the ocular surface.

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. Dry ey negatively affects the quality of life for millions of people. Progressive corneal surface damage secondary to dry eye can lead to visual impairment and has a measurable impact on activities requiring sustained visual attention.

Additionally, in July 2022 Novaliq submitted an NDA seeking approval for NOV03 (perfluorohexyloctane), for the proposed indication of treating the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction. In addition to CyclASol, the company continues to progress multiple additional pipeline opportunities based on its validated EyeSol platform, both in ophthalmology and adjacent indications like dermatology.