NovaTears® is a first-in-class, preservative-free eye lubricant and tear film stabilizer in evaporative dry eye disease.
What are the benefits of NovaTears®?
NovaTears® key benefits:
- prevents evaporation; same refractive index as water
- excellent spreading properties on the eye, long duration
- preservative-free eye lubricant for stabilization of the lipid layer
- small drops size (ca. 10µl) matching the dimensions of the eye
- no blurring, silky feeling
What is special about NovaTears®?
As the first-of-its kind, NovaTears® offers a new Mode of Action by acting as a lubricating lipid layer stabilizer and evaporative barrier for improving tear film stability and quality.
NovaTears® is clinically validated by significant improvement in signs & symptoms in evaporative dry eye disease and MGD patients (4 clinical trials). Approved and marketed in Europe under the brand name EvoTears® by Ursapharm. Recently NovaTears® was approved in New Zealand and in Australia; it is marketed under the brand name NovaTears® by AFT Pharmaceuticals (AFT).
What is the regulatory status of NovaTears®?
- In Europe the product is registered as CE-marked product under the medical device directive.
- In New Zealand and Australia, NovaTears® has received registrational approval as medical device in Oct 2017
- In the USA we are pursuing a New Drug Application (NDA) for NovaTears® with the next important milestone, a phase 2 study starting in 2017.
- In Japan, we have received the classification of NovaTears® as Medical Device from PMDA and will submit the approval dossier following a clinical study in Japan.
In which countries are NovaTears® currently available?
In Europe, NovaTears® is partnered with Ursapharm under the brand name EvoTears® and is quickly establishing a strong presence in the European dry eye market based on superior clinical data. Currently EvoTears® has been successfully launched in 7 European countries by Ursapharm, beginning in 2015 with in Germany & Austria. More countries of the European Economic Area (EEA) are expected to launch EvoTears® soon.
In Australia and New Zealand NovaTears® is marketed by AFT Pharmaceuticals (AFT).
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