Cis-UCA eye drops for dry eye

45 million people in Europe and the USA are estimated to suffer from dry eye syndrome. Up to 40% of those cases are moderate to severe.1

herantis_image_09Dry eye syndrome is the most common cause of irritation in the eye. Patients with dry eye often experience discomfort in a variety of forms including irritation, inflammation, or the sensation of a foreign body in the eye. The condition may be temporary or chronic. Dry eye is highly prevalent in women at the age of 40 and the incidence of dry eye syndrome is expected to grow with aging population and increasing use of computers.

Yet today only one prescription medicine, cyclosporine (Restasis), is available in the USA and none in Europe for the treatment of dry eye. Cyclosporine fails to provide relief for all patients and has side effects such as eye burning. Current treatments for dry eye are almost exclusively based on the use of topically applied artificial tear products/lubricants to restore or maintain the tear film over the eyes, which have little effect on the inflammation causing the symptoms.

Cis-urocanic acid (cis-UCA) has been demonstrated to suppress the inflammatory response in ocular epithelial cells. Cis-UCA also has shown a strong cytoprotective effect on the ocular epithelial cells, reversing the loss of cell viability in response to the UVB stress. This observation has important implications in the treatment of inflammatory eye conditions since chronic stress (e.g., inflammation at the ocular surface) is directly linked to cytotoxicity in epithelial cells. Preclinical studies in relevant animal models of eye inflammation also demonstrate strong proof-of-concept for the cis-UCA eye drops.

Clinical development

A multiple dose Phase I study of Cis-UCA Eye Drops was conducted in the EU in 37 healthy volunteers. Cis-UCA Eye Drops were administered twice daily over 14 days. The results showed excellent local and systemic tolerability without any functional effects on the eyes.

Phase II study in patients with dry eye syndrome was completed in the US in 2015. While this placebo-controlled, randomised and blinded study in 161 patients failed to meet its primary endpoints it suggested that Cis-UCA Eye Drops are safe and as well tolerated as placebo while they showed a significant benefit compared to placebo in certain secondary endpoints.

1 Market Scope 03/2013