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
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.
Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023
VAUGHAN, Ontario, and HEIDELBERG, Germany, March 22, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.Heidelberg, Germany, and Cambridge, MA, USA, Feb 8, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.