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 on they eye 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 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 (CYS-002): Wirta et al., Ophthalmology 2019

In the ESSENCE-1, the phase 2b/3 CYS003 trial (NCT03292809), 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 data of the ESSENCE-1 trial, 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 2020, leading to NDA submission in 2022.

*In November 2019, Jiangsu Hengrui Medicine (SHA 600276) announced the closing of an exclusive license agreement to develop, manufacture, and commercialize NOV03 and CyclASol® for the treatment of dry eye disease in People’s Republic of China including mainland China, Hong Kong, Macau and Taiwan. Jiangsu Hengrui Medicine will be responsible for all development, regulatory and commercialization activities and related expenses in the territory.

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