Skip to main content

New clinical study shows Novaliq NovaTears®+Omega-3 eye drops is a significantly effective treatment for dry eye disease

NovaTears®+Omega-3, an innovative dry eye treatment in-licensed and distributed in Australia and New Zealand by AFT Pharmaceuticals, is a significantly effective treatment for evaporative Dry Eye Disease (DED), a new clinical study1 has found.

Dry Eye is multifactorial and common disease. The 2020 Vision Index showed 77% of Australians have experienced dry eye2. More than 85% of patients suffer from some form of evaporative DED3, yet currently there are a limited number of medicines available to specifically target evaporative DED and relieve ocular symptoms, which include reddened and inflamed eyes and eyelid margins or encrusted eyelids.

Evaporative DED is caused by excessive tear evaporation due to an abnormal tear film lipid layer, or dysfunction of the meibomian glands, the sole natural source of tear lipids producing glands which line the margin of eyelids.

NovaTears®+Omega-3 combines for first time the highly effective tear film stabilizer perfluorohexyloctane with a high quality, vegan sourced Omega-3 fatty-acid. It was developed by Germany’s Novaliq and was shown to deliver clinically relevant and statistically significant improvements in dry eye symptoms in a recent study of 36 patients over eight weeks.

The improvements were evident on a broad range of measures including total corneal staining (NEI scale)4 and Tear Film Break-up Time (TBUT)5 over the course of the study.

Of particular interest was the Meibomian Gland Assessment (MGD) score which improved from an entry level score of 7.1 to 3.0 (p<0.0001) over the course of the study. The latter result supports the hypothesis that the treatment might liquify meibum secretion excreted from the meibomian glands.

AFT Managing Director Hartley Atkinson said: “Since launching Novaliq’s NovaTears® in 2018 and NovaTears®+Omega-3 in 2020, demand for the products has grown rapidly.

“In the last year alone, we have moved from the number three to number two position in the lubricating eyecare category in Australia6 with sales growth from the NovaTears® range contributing to our growth.

“This study confirms what our customers already know: NovaTears®+Omega-3 and NovaTears® are effective treatments that deliver significant improvements in the symptoms of DED.

“AFT works to improve health by identifying health needs and working with industry leaders such as Novaliq to distribute clinically proven solutions to improve health outcomes in our markets.

“Novaliq is leading the way with high quality DED products that are the first of their kind and offer a significant point of difference to competitors. It is gratifying to be able to help people who suffer from this debilitating disease.”

Novaliq Managing Director and CEO Christian Roesky Ph.D. said: “Novaliq is focused on the development and commercialisation of first-and best-in-class ocular therapeutics. We are delighted with the results of this study, which further affirm our confidence in NovaTears+Omega-3 and clinical value we bring to patients.

“The product is the only one of its type available and it highlights the success of our drive to provide enhanced solutions for addressing dry eye. We are delighted our partner AFT has been so successful in bringing our products to people in Australasia.”

For and on behalf of AFT Pharmaceuticals Limited, Malcolm Tubby, CFO

Footnotes

  1.  Novaliq multi-centre, single arm, post-market clinical follow-up study to evaluate the safety and efficacy of NovaTears + Omega-3 (0.2%) eye drops on signs and symptoms of dry eye
  2. The 2020 Vision Index, an Optometry Australia initiative “Taking a closer look at Australia’s eye health”, pp.10.
  3. 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.
  4. NEI Corneal staining is a measure of corneal and conjunctival damage
  5. Tear Film Break Up Time is a measure tear stability and rate of tear loss by evaporation
  6. iRi Report MAT 04/07/21 Australia Pharmacy Value

For more information:

Dr Hartley Atkinson Managing Director AFT Pharmaceuticals Tel: +64 9488 0232
About AFT Pharmaceuticals

Richard Inder
The Project
Tel: +64 21 645 643

About AFT Pharmaceuticals

AFT is a growing multinational pharmaceutical company that develops, markets and distributes a broad portfolio of pharmaceutical products across a wide range of therapeutic categories which are distributed across all major pharmaceutical distribution channels: over-the-counter (OTC), prescription and hospital. Our product portfolio comprises both proprietary and in-licensed products, and includes patented, branded and generic drugs. Our business model is to develop and in-license products for sale by our own dedicated sales teams in our home markets of Australia and New Zealand and in certain Asian markets, and to out-license our products to local licensees and distributors to the rest of the world. For more information: aftpharm.com

About Novaliq

Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on www.novaliq.com.

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.