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

Novaliq Announces Positive Topline Results for Second Phase 3 Trial (Essence-2) of CyclASol® in Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, USA, December 21, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced key results of the second pivotal Phase 3 trial (ESSENCE-2) evaluating the investigational drug CyclASol® for the treatment of dry eye disease (DED).

Phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) conducted by Jiangsu Hengrui Pharmaceuticals in the People’s Republic of China shows statistically significant topline results

Heidelberg, Germany, and Cambridge, MA, USA, December 16, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today provided a development update on the phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) for the treatment of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD) conducted by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”) (SSE: 600276) in the People’s Republic of China showing statistically significant topline results compared to 0.6% sodium chloride solution.1

Novaliq receives EU Quality Management Certificate according to new Medical Device Regulation (MDR)

Heidelberg, Germany, October 12, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that it has implemented and applies a quality management system in accordance with Annex IX, Chapter I of the EU Medical Device Regulation (MDR), for conformity assessment of its medical devices NovaTears®, NovaTears®+Omega-3 and EvoTears™ OMEGA.

Bausch + Lomb announces statistically significant Topline Results from the Second Phase 3 Trial of NOV03 (perfluorohexyloctane) in Dry Eye Disease associated with Meibomian Gland Dysfunction

LAVAL, QC and HEIDELBERG, Germany, Sept. 30, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Novaliq GmbH (“Novaliq”), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the second Phase 3 (MOJAVE) trial evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The companies announced statistically significant topline data from the first Phase 3 trial (GOBI trial) in April 2021.

Novaliq Completes Enrollment of Second Phase 3 Study for CyclASol® for the Treatment of Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, August 10, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the second of two Phase 3 (ESSENCE-2) studies, evaluating the investigational drug CyclASol® to treat the signs and symptoms of dry eye disease DED, has been completely enrolled with a total of 834 participants.