German-based pharmaceutical company Novaliq has completed enrolment for its Phase ll clinical trial of cyclASol to treat moderate to severe dry eye disease (DED).
CyclASol is a clear, preservative-free ophthalmic solution of cyclosporine A formulated using Novaliq’s proprietary EyeSol technology.
The technology is designed to improve the topical bio availability, stability and safety of traditionally insoluble or unstable drugs improving the delivery, efficacy and convenience of treatments for ocular surface diseases including dry eye through preservative free and multi-dose formulations.
Novaliq noted that the double-masked, placebo-controlled, multi-centre, Phase ll trial is evaluating the safety, efficacy and tolerability of cyclASol to treat DED.
The trial enrolled 207 patients who were randomised to one of four treatment groups, including two cyclASol groups, a placebo (vehicle control) group and an open label cyclosporine A 0.05% ophthalmic emulsion group.
During the study, subjects are self-administering one drop twice daily, and returning for examination periodically and at the end of the trial at four months.
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The trial is being conducted in four US sites, with results expected by the end of this year.
Andover Eye Associates principal investigator Dr Gail Torkildsen said: "Dry eye is a common condition and one that often develops as a person ages.
"Due to its novel vehicle, aqueous-free formulation, and improved tolerability, CyclASol has the potential to make a difference for those who suffer from dry eye disease."
Established in 2007, Novaliq aims to transform poorly soluble drugs into effective ocular therapeutics for both the front and back of the eye.