Novaliq Announces Last Patient Enrolled in Phase 2 Clinical Trial of CyclASol® for the Treatment of Moderate to Severe Dry Eye Disease

HEIDELBERG, Germany–(BUSINESS WIRE)–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
proprietary 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 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.