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New clinical study – Novaliq NovaTears(R)+Omega-3 eye drops

Operational Update28 July 2021AFTHealthcare

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:

ARBN 609 017 969






29 July 2021


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 study

1

has found.

Dry Eye is multifactorial and common disease. The 2020 Vision Index showed 77% of

Australians have experienced dry eye

2

. More than 85% of patients suffer from some

form of evaporative DED

3

, 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 Australia

6

with sales growth from the NovaTears

®


range contributing to our growth.

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:

ARBN 609 017 969


“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 Richard Inder

Managing Director The Project

AFT Pharmaceuticals Tel: +64 21 645 643

Tel: +64 9488 0232


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

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:

ARBN 609 017 969


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.

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