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:

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

Novaliq and Laboratoires Théa Announce Partnership and EU Approval for Vevizye (Ciclosporin 0.1% Eye Drops Solution)

Heidelberg, Germany, Cambridge, MA, USA, and CLERMONT-FERRAND, France, October 2, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol^® water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group in Europe, announce European Commission approval of Vevizye^® (ciclosporin 0.1% eye drops solution) in Europe and the closing of a partnership under which Théa has acquired the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa (MENA).

Novaliq Receives Positive CHMP Opinion FOR Vevizye^® in Dry EYE Disease

Heidelberg, Germany, and Cambridge, MA, USA, July 29, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol^® water-free technology, announces that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for Vevizye^®, intended for the treatment of moderate to severe dry eye disease in adult patients, which has not improved despite treatment with tear substitutes.

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol^® (Ciclosporin eye drops, solution 1 mg/mL) for the Treatment of Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, USA, August 24, 2023 – Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU).

Harrow Acquires U.S. and Canadian Commercial Rights to VEVYE^® (Cyclosporine Ophthalmic Solution) 0.1% from Novaliq

VEVYE^® is the First and Only Cyclosporine-Based Product Indicated for the Treatment of Both Signs and Symptoms of Dry Eye Disease with Efficacy Demonstrated After Four Weeks VEVYE^® is the Only Water-Free Ophthalmic Product with Convenient Twice-Daily (BID) Dosing NASHVILLE, Tenn. & HEIDELBERG, Germany, July 18, 2023 – Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Novaliq GmbH, a German biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced an agreement under which Harrow will acquire the U.S. and Canadian commercial rights for VEVYE^® (cyclosporine ophthalmic solution) 0.1%, a patented, non-preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol^® water-free technology. VEVYE, which is dispensed topically in a unique 10 microliter per one drop and is labeled for twicedaily (BID) dosing, is the first and only cyclosporine-based product indicated for the treatment of both signs and symptoms of dry eye disease (DED). VEVYE was approved on May 30, 2023, by the U.S. Food and Drug Administration (FDA).

Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan

Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan Osaka, Japan & Heidelberg, Germany, and Cambridge, MA, USA, June 13, 2023 – Senju Pharmaceutical Co., Ltd., a researched-based Japanese pharmaceutical company focusing the field of ophthalmology, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on its unique EyeSol^® water-free technology, are pleased to announce the closing of a license agreement on Japan rights to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane ophthalmic solution), the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation.

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