Novaliq GmbH, a pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, announced today the completion of enrollment in its Phase 2 clinical trial that is evaluating the safety, efficacy and tolerability of CyclASol® for the treatment of moderate to severe dry eye disease (DED). CyclASol is a clear, preservative-free ophthalmic solution of cyclosporine A formulated using Novaliq’s proprietory EyeSol® technology.
The double-masked, placebo-controlled, multi-center Phase 2 trial enrolled 207 patients who were randomized to one of four treatment groups that included two CyclASol groups, a placebo (vehicle control) group and an open label cyclosporine A 0.05% ophthalmic emulsion group. Study subjects are selfadministering one drop twice daily, and returning for examination periodically and at the end of the trial at four months. The trial is being conducted in four sites in the U.S. Topline results are anticipated by the end of 2016.
“Completing patient enrollment in this Phase 2 trial represents a significant milestone in our clinical development plan,” says Bernhard Günther, managing director and CEO of Novaliq GmbH. “Given the limited treatment options currently available for patients with moderate to severe DED, there is a need for novel, effective treatments.”
“I’m pleased to be participating in this study,” says Gail Torkildsen, MD, Principal Investigator, Andover Eye Associates. “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.”