Receives IND clearance for Phase 2b program in U.S.

Topline data from ongoing Phase 2b clinical trial to be reported in Q4 2022

TEL AVIV, Israel & MELBOURNE, Australia--(BUSINESS WIRE)--Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its Phase 2 clinical study protocol of AZR-MD-001 in Meibomian Gland Dysfunction (MGD). AZR-MD-001 is currently being studied in an ongoing multi-center Phase 2b clinical trial and topline data is expected in the fourth quarter of 2022.

“Meibomian Gland Dysfunction is the leading cause of Dry Eye Disease and Contact Lens Discomfort impacting millions of people in the U.S. alone,” said Marc Gleeson, CEO of Azura Ophthalmics. “We believe twice-weekly treatment with AZR-MD-001 has the potential to restore the normal flow of meibomian gland secretions and address the high unmet needs existing in eye health. The unique keratolytic properties of AZR-MD-001 enable the agent to not only target the signs and symptoms of ocular surface diseases, but also address the underlying root cause of these underserved conditions. We look forward to the continued clinical advancement of AZR-MD-001 to bring a new class of Ophthalmic Keratolytics to millions of patients who are central to our work here at Azura.”

Azura is currently conducting a multi-center, double-masked, vehicle-controlled Phase 2b study that will evaluate the safety and efficacy of AZR-MD-001 in patients with MGD. Primary endpoints will include patient-reported symptoms as measured by the Ocular Surface Disease Index©1 (OSDI) score, the quality of fluid secretion as measured by the Meibomian Gland Score (MGS) and the number of glands secreting meibum as measured by the Meibomian Glands Yielding Liquid Secretion (MGYLS) score. The ongoing study builds upon previous findings from a successful Phase 2a clinical trial evaluating AZR-MD-001 in the same patient population.

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).1,2 MGD is commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion.3 There are no approved prescription pharmaceutical agents that specifically treat these glandular changes. If left untreated, MGD will alter the tear film, which can initiate or exacerbate additional ocular surface diseases such as DED, resulting in corneal ulcers, ocular infections, and blindness.

About AZR-MD-001

Azura’s lead clinical-stage drug candidate, AZR-MD-001 harnesses the power of selenium sulfide (SeS2) in an easy-to-use ophthalmic ointment preparation applied directly to the meibomian glands. AZR-MD-001 is thought to have a multi-modal mechanism of action that treats the pathophysiology of Meibomian Gland Dysfunction (MGD) along with the resulting ocular surface symptoms. 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, efficacy and tolerability of the study drug in patients with MGD and Evaporative Dry Eye Disease (DED). Azura expects to report Phase 2b three-month 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 to treat underserved ophthalmic conditions. Our differentiated approach combines ophthalmologic and dermatologic solutions to harness the unique properties of keratolytics to treat the root cause of numerous underserved ocular indications. Our internally discovered pipeline of new chemical entities allows us to develop a portfolio of first-in-class ophthalmic therapeutics for significant unmet needs. For more information visit: www.azuraophthalmics.com and follow Azura on LinkedIn and Twitter.

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References

1. Ocular Surface Disease Index (OSDI) Version 1 © 1995 Allergan All Rights Reserved.

2. 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.

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

4. 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.

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