Novaliq Submits NDA for Novel Dry Eye Disease Treatment

Armed with positive results from two late-stage studies, Germany’s Novaliq has submitted a New Drug Application (NDA) to the FDA for its novel treatment for dry eye disease.

CyclASol (cyclosporine ophthalmic solution) is an anti-inflammatory and selective immunomodulatory drug that is soluble in the company’s EyeSol water-free technology, which enables high bioavailability of active pharmaceutical ingredients.

In the multicenter studies, CyclASol showed clinical meaningful improvement of ocular surface damage and in patients’ ability to produce tears.

The effects were maintained and even improved over 12 months, the company said.