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 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.

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.

Enrollment of second phase 3 trial for NOV03 completed

LAVAL, QC and HEIDELBERG, Germany, July 7, 2021 /PRNewswire/ — Bausch + Lomb, a leading global eye health business of BauschHealth Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”), and Novaliq GmbH, a biopharmaceutical companyfocusing on first- and best-in-class ocular therapeutics, today announced the second of two Phase 3 (MOJAVE) studies evaluating theinvestigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs andsymptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD), has been completely enrolled with a total of622 participants.

Novaliq Announces More than 50% Patients Enrolled in CyclASol® Phase 3 Dry Eye Disease Trial ESSENCE-2

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Heidelberg and Cambridge, MA – April 28, 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 the second Phase 3 clinical trial evaluating CyclASol® to treat the signs and symptoms of dry eye disease (DED) has randomized more than 50% out of 834 targeted patients, with top-line results expected in the 2nd half of 2021.

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TAMPA, FL, UNITED STATES, April 20,2021 /EINPresswire.com/ — Betaliq, Inc., a clinical-stage ophthalmic company focused on developing therapies for the treatment of glaucoma, today announced enrollment of the first subject in their Phase 2 clinical trial. Betaliq’s pipeline consists of two preservative-free and water-free glaucoma drug candidates based on Novaliq GmbH’s EyeSol® technology. EyeSol is the worldwide first and only water-free technology for topical ophthalmology products. Two EyeSol based ophthalmic products are currently approved in Europe and Australia and two active INDs are in late-stage development in the United States.