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NovaTears®

Novaliq GmbH, a specialty pharmaceutical company with the first water-free technology platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, announced that NovaTears®, a novel topical treatment of dry eye disease (DED) and meibomian gland dysfunction (MGD), is now also available in Australia.

Dry eye is a chronic condition affecting about one third of Australian adults and half of those aged over 50. At a minimum, dry eye causes discomfort, but it can also cause disabling pain and fluctuating vision, substantially affecting vision-related quality of life by limiting such activities as driving and reading, as well as recreation. Dry eye also influences productivity in the workplace by making it more difficult to use a computer or read for extended periods, decreasing tolerance for certain environments, and reducing work time.1

Approximately 20 % of the Australian adult population suffers from DED. Research suggests that up to 48 % of office workers could experience dry eye, due to their long exposure to air-conditioning and computer screens.2

Just eight months after launching in New Zealand, AFT Pharmaceuticals Ltd (AFT) has achieved registration of NovaTears® in Australia. AFT, a New Zealand-based pharmaceutical company listed on ASX and NZX, is an ophthalmic leader in the region and commercializes NovaTears® across Australasia.

NovaTears® is 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 report3, patients with tear-lipid dysfunction account for the greater proportion of all DED patients. With the distribution of NovaTears® an adequate treatment option for evaporative dry eye is available in Australia now.

NovaTears® has a unique mode of actions: one drop immediately stabilizes the lipid layer without causing vision blurring for several hours. Clinically validated in four clinical trials, NovaTears® eye drops have been proven to be safe and efficacious for treating the signs and symptoms of DED and 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 meibum quality have been improved under NovaTears® treatment.

“With the introduction of NovaTears®, dry eye sufferers in Australia now have a new and highly efficacious treatment option that provides significant improvement to the signs and symptoms of evaporative DED,” said Christian Roesky, PhD, managing director and CEO, Novaliq GmbH. “Unlike other currently available DED products, NovaTears® provides more than comfort: it stabilizes the lipid layer several hours and

restores the natural tear film of the eye over time. I am confident that patients will welcome this breakthrough.”

“We are delighted to be able to offer patients a novel DED treatment, that is preservative and water-free, with no blurring or stinging, and provides no further irritation to the eye surface,” said Hartley Atkinson, PhD, CEO, AFT. “NovaTears® is a welcome addition to our eye care line.”

About Novaliq :

Novaliq is an ophthalmic pharmaceutical company based in Heidelberg, Germany with an office in Cambridge, U.S. Novaliq’s mission is to transform ocular therapeutics based on EyeSol®, the first and only water-free technology, enhancing the topical bio-availability, stability and safety of traditionally insoluble or unstable drugs. Novaliq has developed a tiered portfolio of differentiated products addressing the needs of eye patients: NovaTears®, marketed under CE-approval in Europe as EvoTears® by Ursapharm and in Australia/NewZealand as NovaTears® by AFT is improving the signs and symptoms of dry eye disease (DED). Two prescription drugs are in late stage clinical development: CyclASol®, an anti-inflammatory and immunomodulating drug for the treatment of DED with a demonstrated early onset of action and excellent tolerability, is evaluated in the pivotal ESSENCE phase 2b/3 trial. NOV03, the first drug addressing evaporative DED associated with meibomian gland dysfunction (MGD), is evaluated in the SEECASE phase 2 trial. Results for both U.S. trials are anticipated in Q3 2018. More on www.novaliq.com