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.
“Completing patient enrollment in this Phase 2 trial represents a significant milestone in our clinical development plan”
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 self-administering 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.”
About Novaliq – Novaliq GmbH, founded in 2007, is a Heidelberg based specialty pharmaceutical company focused on ophthalmology. Its mission is to transform poorly soluble drugs into effective ocular therapeutics for both the front and the back of the eye. Novaliq’s proprietary EyeSol technology enhances 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’s most advanced product is NovaTears® with CE-marking based on Novaliq’s proprietary EyeSol Technology. NovaTears is marketed under the brand name EvoTears™ in Europe. More on www.novaliq.com.
Bernhard Günther, + 49 6221 502 5911
Managing Director, CEO
Oliver Schlüter, PhD: + 49 6221 502 59155
Managing Director, CFO
Scotia Vision Consultants
Michael O’Rourke, + 1 813 323 1438