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Novaliq’s NovaTears® Treatment for Evaporative Dry Eye Disease Launches in New Zealand and Receives Registrational Approval in Australia

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Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced the launch of NovaTears® in New Zealand and registrational approval in Australia.

According to McCarty, the prevalence of dry eye disease (DED) is approximately 7.4 percent in Australia and New Zealand; counting for more than 2 million people suffering from dry eye disease in this region1.

In March 2017, Novaliq and AFT Pharmaceuticals (AFT) signed an exclusive licensing partnership agreement for the commercialization of NovaTears® across Australasia. AFT Pharmaceuticals Ltd (AFT), a New Zealand-based pharmaceutical company listed on ASX and NZX, will commercialize NovaTears®, the first and only water-free topical eye drop treatment specifically developed to treat patients with DED. According to the latest TFOS DEWS II definition and classification report2, patients with tear-lipid dysfunction account for the greater proportion of all DED patients and no adequate treatment option was available in New Zealand until now.

NovaTears® immediately stabilizes the lipid layer without causing vision blurring. Clinically validated in four clinical trials, NovaTears® eye drops are proven to be safe and effective. Results from these trials showed that NovaTears® is safe and efficacious for treating the signs and symptoms of DED and Meibomian Gland Dysfunction (MGD). A large number of objective disease parameters such as tear film breakup time, corneal and conjunctival fluorescein staining but also a number of expressible Meibomian glands and Meibom quality have been improved under NovaTears® treatment.

“NovaTears® is a first-in-class treatment for this common and highly underserved ophthalmic disease,” said Christian Roesky, PhD, managing director and CEO, Novaliq GmbH. “NovaTears® is a clinically validated treatment that significantly improves signs and symptoms of patients suffering from dry eye disease. We know from our clinical studies that NovaTears® immediately stabilizes the lipid layer and restores the natural tear film of the eye over time. I am confident that dry eye patients in Australasia will greatly benefit from this breakthrough innovation.”

For patients, NovaTears® eye drops combine high efficacy with great comfort. Signs and subjective symptoms of DED are significantly reduced without causing blurry vision after application. NovaTears® is pure, and therefore has no side effects related to preservatives or other additives.

For healthcare professionals, NovaTears® expands the established treatment portfolio with a new option of a water-free formulation and a new mode of action to treat more patients effectively. NovaTears® increases patients’ compliance due to proven clinical effectiveness and tolerability.

“We are thrilled to be able to offer patients a novel ophthalmic treatment that addresses signs and symptoms of evaporative DED and MGD,” said Hartley Atkinson, PhD, CEO, AFT. “NovaTears® is a first-in-class, water-free and preservative-free treatment that strengthens the lipid layer of the tear film thereby preventing evaporation. It is a welcome addition to our eye care line, one that will provide superior benefits to patients.”

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 has developed a tiered and long-term sustainable dry eye family of truly differentiated products that addresses the different needs of dry eye patients. Novaliq’s most advanced product is NovaTears® with CE-approval marketed under the brand name EvoTears® in Europe. CyclASol® a second-generation prescription drug is currently in preparation for a pivotal trial. More on www.novaliq.com.

About AFT Pharmaceuticals – AFT founded in 1997 is an Auckland, New Zealand-based pharmaceuticals company operating in Australia, New Zealand and the Pacific Islands. AFT has been listed on the Australian [ASX] and New Zealand [NZX] stock exchanges since December 2015 and has significant local sales operations in Australasia together with R&D activities in pain, orphan drugs and medical devices.

Sources:

1. McCarty CA, Bansal AK, Livingston PM, Stanislavsky YL, Taylor HR. The epidemiology of dry eye in Melbourne, Australia. Ophthalmology 1998;105(6):1114-9
2. TFOS DEWS II Definition and Classification Report 2017

Contact information

NOVALIQ GmbH
For US:
Michael O’Rourke, + 1 813 323 1438
Strategic Consultant, ext.
mrourke@novaliq.com
or
For EU/Asia:
Heidrun Kirsch, + 49 6221 50259 243
VP Marketing
hkirsch@novaliq.com

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