Funding awarded by Brandon BioCatalyst’s CUREator

TEL AVIV, Israel & MELBOURNE, Australia--(BUSINESS WIRE)--Azura Ophthalmics Ltd. (Azura), a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced that the company was awarded a grant from CUREator, Australia’s national biomedical incubator managed by Brandon BioCatalyst. The grant will support Azura’s two-stage study evaluating the safety, tolerability and efficacy of the company’s lead clinical candidate, AZR-MD-001, in patients with contact lens discomfort (CLD) who show evidence of Meibomian gland dysfunction (MGD).

“We are excited to be awarded this CUREator grant and believe it further serves to validate our differentiated approach of combining ophthalmologic and dermatologic solutions to exploit the properties of keratolytics to treat the root cause of contact lens discomfort and other ocular surface indications,” said Marc Gleeson, CEO of Azura Ophthalmics. “Meibomian gland dysfunction is the primary cause of CLD and is directly implicated in the eye dryness and discomfort millions of contact lens wearers experience.”

Fiona Stapleton, Scientia Professor, School of Optometry and Vision Science at University of New South Wales Sydney, commented, “We are pleased Azura has been awarded this grant and look forward to continuing our collaborative evaluation of AZR-MD-001 for CLD. Our pilot study met its primary endpoints by showing statistically significant improvements in multiple measures of Meibomian gland secretion and patients’ ability to wear contact lenses as desired.”

Background on AZR-MD-001 in patients with CLD

It is estimated there are 140 million contact lens wearers worldwide and over 44 million wearers in the U.S. alone. Up to 51% of lens wearers "drop out" of contact lens wear citing CLD as the primary reason for discontinuation.1

Azura evaluated AZR-MD-001 ointment (1.0%) as a potential treatment for CLD in an early pilot study: SOVS2019-070 (the ECLIPTIC study). Significant improvements over baseline were observed in meibum gland secretion score (MGS) and number of meibomian glands yielding liquid secretion (MGYLS) following treatment with AZR-MD-001 for 3 months (p &< 0.0086 and p &< 0.0151, respectively). Analyses from the University of New South Wales (UNSW) conducted by Professor Fiona Stapleton found that AZR-MD-001 showed a statistically significant improvement over baseline in CLDEQ-8 score at 1 and 4 months (p&<0.01) and an improvement in the visual symptoms subscale (frequency and severity of fluctuating vision) of the CLDEQ-8 (p=0.02) for the same periods.2 This impact of AZR-MD-001 on visual function was also found in an integrated Phase 2a analysis across four studies conducted by Azura in patients with MGD. Results from the integrated analyses indicated significant drug effects on the Visual Function subscale of the Ocular Surface Disease Index (OSDI).

The significant impact of AZR-MD-001 on visual function observed across the studies is hypothesized to be the result of increasing meibum release and/or production. Increasing meibum release and/or production strengthens the lipid layer of the tear film which in turn should increase the stability of the precorneal tear film. Since the precorneal tear film is the first major refractive surface in the eye, this should stabilize visual quality and could explain the observed improvements in vision-related patient-reported outcomes.

About Meibomian Gland Dysfunction

Meibomian gland dysfunction (MGD) is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum. It is the leading cause of Dry Eye Disease (DED) and contact lens discomfort (CLD).3,4 MGD is commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion.5 There are no approved prescription pharmaceutical agents that specifically treat these glandular changes. If left untreated, MGD will alter the tear film, resulting in damage to the front of the eye and severe discomfort from associated ocular surface diseases.

About Contact Lens Discomfort

Contact lens discomfort (CLD) is a condition where lens wearers experience pain and irritation, causing them to reduce their lens-wearing time or completely stop wearing them. The use of contact lenses can stress the tear film, resulting in instability and alterations of the lipid layer, and can cause symptoms to unexpectedly manifest in patients with mild MGD who are otherwise asymptomatic.6 There are currently no approved pharmacologic treatments for CLD and there are no treatments available that can significantly improve the debilitating symptoms associated with CLD such as blurred, fluctuating vision and discomfort.

About AZR-MD-001

Azura’s lead clinical-stage drug candidate, AZR-MD-001, is a topical ointment that has been developed to yield properties ideal for ophthalmic use. The formulation is applied to the lower lid margin twice a week before bedtime.

AZR-MD-001 leverages Selenium Sulfide (SeS2) as the active ingredient. SeS2 has been identified to be an ideal candidate for treating Meibomian gland dysfunction (MGD) due to its multi-mechanism of action targeting the pathophysiology of MGD. It breaks down the bonds between abnormal keratin proteins to soften the blockage, slows down the production of keratin to prevent future blockages and increases the quantity of lipid produced by the meibomian glands.

AZR-MD-001 is currently being studied in a Phase 2 trial to evaluate the safety, tolerability and efficacy of the study drug in patients with MGD and Evaporative Dry Eye Disease (DED). Azura expects to report topline data in the fourth quarter of 2022.

About Azura Ophthalmics, Ltd.

Azura Ophthalmics is utilizing our deep understanding of ocular surface diseases and drug development to deliver a new therapeutic class of Ophthalmic Keratolytics. Our differentiated approach combines ophthalmologic and dermatologic solutions to exploit the unique properties of keratolytics to treat the root cause of numerous underserved ocular indications. Led by our clinical-stage program, initially focused on resolving the signs and dramatically improving the symptoms of Meibomian gland dysfunction (MGD), our internally developed pipeline addresses the full spectrum of lid margin and ocular surface diseases. For more information visit: www.azuraophthalmics.com and follow Azura on LinkedIn.

About CUREator

Delivered by Brandon BioCatalyst, CUREator is backed by the Australian Federal Government’s Medical Research Future Fund. The MRFF’s $80 million Early Stage Translation and Commercialisation Support Grant (ESTAC) aims to assist businesses to develop projects that support medical innovation in Australia through to proof-of-concept and beyond, providing opportunities for commercialisation. CUREator is responsible for managing $40m of this fund, dedicated to supporting commercialisation of both preclinical medical innovations and early clinical development of therapeutics.

For more information about CUREator visit: https://brandonbiocatalyst.com/cureator/

References

1. Nichols JJ, Willcox MDP, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: Executive Summary. Invest Ophthalmol Vis Sci. 2013;54:TFOS7–TFOS13.

2. Stapleton F, Tan J, Jia T, DrPuy V, Gleeson M and Bosworth C. The effect of a novel sulfide-containing topical treatment on ocular signs and symptoms in symptomatic contact lens wearers: an exploratory study. ARVO Abstract, Inv Ophthal & Vis Sci, 2021; 62:1259.

3. Milner, M. S., Beckman, K. A., Luchs, J. I., Allen, Q. B., Awdeh, R. M., Berdahl, J., Boland, T. S., Buznego, C., Gira, J. P., Goldberg, D. F., Goldman, D., Goyal, R. K., Jackson, M. A., Katz, J., Kim, T., Majmudar, P. A., Malhotra, R. P., McDonald, M. B., Rajpal, R. K., Raviv, T., … Yeu, E. (2017). Dysfunctional tear syndrome: dry eye disease and associated tear film disorders – new strategies for diagnosis and treatment. Current opinion in ophthalmology, 27 Suppl 1(Suppl 1), 3–47. https://doi.org/10.1097/01.icu.0000512373.81749.b7.

4. Foulks GN, Bran AJ. Meibomian gland dysfunction: a clinical scheme for description, diagnosis, classification, and grading. Ocul Surf. 2003;1:107-126.

5. Efron N, Jones L, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Interactions With the Ocular Surface and Adnexa Subcommittee. Invest Ophthalmol Vis Sci. 2013;54:TFOS98–TFOS122.

6. Blackie CA, Korb DR, Knop E, Bedi R, Knop N, Holland EJ. Nonobvious obstructive meibomian gland dysfunction. Cornea. 2010;29(12):1333-45.

Contacts

Investor: Ashwin Agarwal Chief Financial Officer 949-439-1865 ashwin.agarwal@azuraophthalmics.com

Media: Tara Mulloy MacDougall Advisors 781-235-3060 tmulloy@macdougall.bio