Novaliq’s NovaTears® Treatment for Evaporive Dry Eye Disease is now available across Australia and New Zealand

Heidelberg, Germany – June 28, 2018 – 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 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. Janine A. Clayton, N Engl J Med 2018;378:2212-23
  2. https://www.myvmc.com/diseases/dry-eye-syndrome-keratoconjunctivitis-sicca/
  3. TFOS DEWS II Definition and Classification Report 2017

Sonja Kroesser named Top 25 Women Leaders in Biotechnology of 2022

Heidelberg, Germany, and Cambridge, MA, USA, November 15, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, is proud to announce that today our own Sonja Kroesser, Vice President and Head of Preclinical and Clinical Development, was named as a Top 25 Women Leaders in Biotechnology of 2022 by the Healthcare Technology Report.

Novaliq announces FDA acceptance of the new drug application for CyclaSol® for the treatment of dry eye disease

• PDUFA target action date is June 8, 2023

HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, October 24, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).

FDA accepts NDA filing for NOV03

VAUGHAN, Ontario, and HEIDELBERG, Germany, Sept. 6, 2022 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

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Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Heidelberg, Germany, and Cambridge, MA, USA, August 09, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol® (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).