Skip to main content

In Australia, NovaTears® eye drops are available on the Pharmaceutical Benefits Scheme (PBS) from now on

  • Using innovative new technology, NovaTears® effectively establishes a new class of treatment for Evaporative Dry Eye.
  • Free from preservatives, water and phosphates, and can be used for up to six months after opening.

Heidelberg, Germany – Sep 12, 2018 – Novaliq GmbH, a specialty pharmaceutical company with the first water-free technology platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, is the manufacturer of NovaTears®, a novel topical treatment of dry eye disease (DED) and meibomian gland dysfunction (MGD).

AFT Pharmaceuticals Ltd (AFT) commercializes NovaTears® across Australasia. AFT just announced that NovaTears®, its new preservative-free eye lubricant and tear film stabiliser for the treatment of Evaporative Dry Eye (EDE), has been listed on the Australian Pharmaceutical Benefits Scheme (PBS) from 1st September 2018.
In Australia, NovaTears® is currently available over-the-counter from pharmacies, but from September 1st it can also be prescribed on the PBS, enabling more dry eye patients to benefit from using it.

Research has shown that EDE is by far the most common type of Dry Eye Disease (DED), impacting approximately 86% of DED sufferers (50% experiencing EDE alone and a further 36% experiencing a combination of EDE and aqueous deficiency).i

“NovaTears® is a new class of dry eye therapy based on patented EyeSol® technology, which can provide relief for EDE sufferers, and fulfil a significant patient need,“ explains Dr Hartley Atkinson, pharmacologist and CEO of AFT Pharmaceuticals. “It is long-lasting and spreads very easily across the eye, providing relief without blurred vision, stinging or burning.”
Being water-free is one of the major benefits of NovaTears®, as it means there is no microbial growth possible in the solution and allows for the delivery of preservative-free drops in a convenient multi-dose bottle. NovaTears® also has a much smaller droplet size (ca. 4x smaller) than traditional water-based eye drops, which minimises spill-over.

“Clinical studies of Evaporative Dry Eye Disease and Meibomian Gland Dysfunction patients have shown significant improvement in objective signs and subjective symptoms after using NovaTears® ii”, continues Dr Atkinson. “We are very pleased to see NovaTears® listed on the PBS, allowing greater access to EDE sufferers, particularly those who are sensitive to preservatives.”
“With the positive PBS listing of NovaTears®, more dry eye patients can benefit from this new and highly efficacious treatment for Dry Eye Disease,” said Christian Roesky, CEO of Novaliq GmbH. I am confident that patients will welcome this breakthrough.”

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
i) Lemp, M.A., Crews, L.A., Bron, A.J., Foulks, G.N. and Sullivan, B.D., 2012. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea, 31(5), pp.472-478.
ii) Steven, Philipp, et al. “Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease – A Prospective, Multicenter Noninterventional Study.” Journal of Ocular Pharmacology and Therapeutics 31 (8), 498-503(2015) and Steven, Philipp, et al. “Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease.” Journal of Ocular Pharmacology and Therapeutics. 33(9), 678-685(2017). Sponsored by Novaliq GmbH.

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).
Read more

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.

Read more

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).
Read more

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).
Read more

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.
Read more