CyclASol®

Preservative-free, clear cyclosporine A solution in phase 3
for the treatment of moderate to severe dry eye disease

Novaliq Product CyclaSol

CyclASol® is a topical, preservative-free ophthalmic solution containing the active pharmaceutical ingredient (API) Cyclosporine A at a concentration of 0.1% in EyeSol® which is under clinical evaluation. It is an anti-inflammatory and immunomodulating drug for the treatment of dry eye disease (DED) with a demonstrated early onset of action and excellent tolerability.

CyclASol® is designed to increase residual time and enables high bioavailability to unfold the full potential of cyclosporine A on the ocular surface. The EyeSol® vehicle ensures excellent tolerability and overall safety avoiding the use of oils, surfactants and preservatives.

Cyclosporine A has a critical and known mode-of-action in DED and has been proven to be the a successful API for the treatment of DED in the U.S.A..

In January 2017 Novaliq announced positive phase 2 results evaluating CyclASol® in 207 patients with moderate to severe DED (CYS002): Wirta et al., Ophthalmology 2019

In the ESSENCE-1, the phase 2b/3 CYS003 trial, CyclASol® 0.1% confirmed unprecedented efficacy for ocular healing including impact on visual symptoms and improvement of visual function, early onset of action and excellent tolerability.

What is the regulatory status of CyclASol®?

Based on the positive topline data of the ESSENCE-1 trial (presented in October 2018), Novaliq has accelerated its development program to make a drug treatment with CyclASol® available soon.

The final pivotal clinical trial (ESSENCE-2, CYS004) is expected to start in 2019, leading to NDA submission in 2021.

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