HEIDELBERG, Germany--(BUSINESS WIRE)--Novaliq GmbH, a drug delivery company focusing on the topical application of ophthalmic technologies for poorly soluble drugs, today announced that its observational study NT-001, which placed NovaTears® OTC eye drops in 30 patients with symptoms of mild to moderate evaporative dry eye disease, successfully demonstrated effectiveness and safety in relief of dry eye symptoms.
The primary objective of the open, prospective, uncontrolled post-market clinical follow-up study (treatment survey) was to confirm whether NovaTears® was able to successfully lubricate the ocular surface, stabilize the eye's tear film, and relieve adverse symptoms associated with dry eye disease. Additionally, local tolerability and safety of NovaTears® was assessed when used in accordance with its approved labeling.
Tear film fluid and stability improved over the study period (measured using industry-standard Schirmer I and TFBUT tests), tear osmolarity remained unchanged and assessment by a subjective dry eye questionnaire revealed that patient symptom severity decreased after use of NovaTears® over a 5-7 week period. Corneal staining (measured using the Oxford Grading Scheme) indicated less corneal damage after treatment, as demonstrated by patient shift towards Grade 0 at follow-up. No changes were observed in either visual acuity or intraocular pressure, indicating that use of NovaTears® eye drops is safe.The primary objective of the open, prospective, uncontrolled post-market clinical follow-up study (treatment survey) was to confirm whether NovaTears® was able to successfully lubricate the ocular surface, stabilize the eye's tear film, and relieve adverse symptoms associated with dry eye disease. Additionally, local tolerability and safety of NovaTears® was assessed when used in accordance with its approved labeling.
"We are very pleased by the positive outcomes of our NT-001 study across all parameters tested," said Bernhard Guenther, Novaliq's President & CEO. "We are convinced that ophthalmologists and patients will embrace NovaTears®as a truly innovative solution among existing eye-drop products".
Philipp Steven, MD, PhD, Center for Ophthalmology, University Hospital of Cologne and coordinating investigator of study NT-001, added: "All results of the study point towards excellent clinical performance, safety and very high convenience and acceptance of NovaTears® for patients suffering from hyper-evaporative dry eye." Investigator and ophthalmologist Thomas Kaercher, MD, Heidelberg noted: "Most of my patient experiences were very positive, and patients frequently requested to continue on NovaTears®treatment following the study's cessation."
Novaliq is currently preparing NovaTears® for market entry in several geographic regions with dedicated ophthalmic partners.
NovaTears® OTC, the first product based on Novaliq's proprietary EyeSol®-Technology, is an innovative multi-dose, non-aqueous, non-blurring and preservative-free topical eye drop formulation for lubrication of the ocular surface. It is intended for use as a wetting agent for the ocular surface and for stabilization of the tear film for the relief of dry eye and irritated eyes symptoms. NovaTears® has been classified as a class IIa medical device and received CE mark approval in Europe in July 2013.
About Novaliq GmbH
Novaliq is a drug delivery company whose goal is to develop innovative pharmaceutical formulations. Novaliq's proprietary semi fluorinated alkanes (SFAs) technology can be used in various routes of administration for the transport of drugs or oxygen for therapeutic purposes. Based on its unique physicochemical properties, Novaliq currently develops innovative ophthalmic formulations and has several product candidates with excellent market potential in various stages of development.
Novaliq welcomes invitations from interested parties to enter into discussions about significant additional development or partnership opportunities.