Clinical Trials

* On February 16 2016, Novaliq GmbH, a pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, announced that it has begun enrolling patients in a Phase 2 clinical trial that will evaluate the safety, efficacy and tolerability of CyclASol® for the treatment of moderate to severe dry eye disease (DED).  This Phase 2 study is a randomized, double-masked, placebo-controlled, multi-center trial, designed to evaluate the safety, efficacy and tolerability of topical CyclASol® for the treatment of moderate to severe DED. Patients will be randomized to one of four treatment groups that include two CyclASol® groups, a placebo (vehicle control) group and an open label cyclosporine A 0.05% ophthalmic emulsion group. Study subjects will self-administer one drop twice daily, returning for examination periodically and at the end of the trial at four months. The study is being conducted in approximately 4 sites in the U.S., and total planned enrollment is 200 patients.
* On September 23, 2014, Novaliq reported positive phase 1 results with the first and only clear cyclosporin solution eye drop formulation in clinical development for patients with dry eye syndrome. Objectives of the 18 patient phase 1, double-blind, randomized, placebo-controlled cross-over study were to investigate safety, local tolerability and systemic exposure of CyclASol® (cyclosporin solution) eye drops and vehicle following single and multiple ocular doses in healthy volunteers. No drug-related signs or symptoms of ocular discomfort or irritation were reported in particular no dryness, grittiness, burning, stinging, tiredness, blurred or foggy vision, redness, watery eyes, eye mucus or crusting. In slit-lamp examinations, no subjects revealed any clinically abnormal signs of the anterior and posterior eye structures. With dosing of up to 4 drops per eye per day, no systemic levels of cyclosporin were detected after any dose or at any time point when using a highly sensitive assay with a LLOQ as low as 0.1 ng/ml.

* On April 3, 2014, Novaliq has announced the commencement of a Phase 1 study for CyclASol (Cyclosporin solution) following US and European patent approval of the solution for the treatment of dry eye syndrome.

While conventional cyclosporin formulations are emulsions, CyclASol is the first and only 0.05% clear cyclosporin solution. CyclASol is available in multi-dose and preservative free bottles for the treatment of dry eye syndrome. CyclASol has demonstrated long-term stability plus superior wettability, pharmacokinetics, and biocompatibility compared to conventional emulsions.

CyclASol was developed from Novaliq’s broad range Semi Fluorinated Alkane (SFA) drug delivery platform EyeSol®, offering significant competitive advantages for multiple drug candidates within ophthalmology, primarily by enhancing the therapeutic effect of poorly soluble drugs.