Supports continued advancement of first-in-class Ophthalmic Keratolytics for ocular surface diseases

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 the company’s U.S. 11,459,351 patent (the ‘351 patent) was granted by the U.S. Patent and Trademark Office. This patent strengthens the company’s extensive portfolio protecting its use of dual-action keratolytic drug conjugates in development for the treatment of ocular diseases associated with the eye lid margin and Meibomian Gland Dysfunction (MGD).

“The expansion of Azura’s IP portfolio to 12 U.S. and European patents, and at least 104 patents and patent applications worldwide, validates our novel approach to harness and develop first-in-class treatments that have the potential to completely change the treatment and outcomes of lid margin and ocular surface diseases,” said Marc Gleeson, Chief Executive Officer of Azura Ophthalmics. “By targeting the underlying cause of these conditions, we believe our pipeline of dual-action keratolytic drug conjugates has the potential to improve the signs, symptoms, and burden of numerous eye conditions being inadequately managed today. Our lead keratolytic, AZR-MD-001, is being investigated for the treatment of MGD in a Phase 2b trial and we look forward to sharing initial results from the study this quarter.”

Azura’s extensive IP portfolio protects various drug conjugates, including azithromycin-keratolytic dual drug conjugates protected in the ’351 patent; lifitegrast-keratolytic dual drug conjugates protected by previously granted U.S. Patent 10,875,845; as well as other disease modulating agents conjugated with keratolytic agents.

This class of conjugated drugs has the potential to expand the treatment options for patients who experience mixed disease mechanisms, including anterior surface Inflammation and meibomian gland hyperkeratosis, which affect their ocular surface.

Azura’s base IP coverage includes patents related to keratolytic method-of-use, manufacturing, formulation, instruction of use, and dosage spanning Meibomian Gland Dysfunction, Dry Eye Disease, Contact Lens Discomfort, blepharitis, Demodex, and immune-mediated ocular surface disease.

About Meibomian Gland Dysfunction

Meibomian Gland Dysfunction (MGD) is a chronic and progressive condition associated with blockage of the meibomian glands in the eye lids 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 on the eye lid. 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.

References

1. 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.

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

3. 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