TEL AVIV, Israel--(BUSINESS WIRE)-- Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing a potential new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced multiple presentations highlighting positive efficacy and safety data from Phase 2 studies of the company’s lead drug candidate, AZR-MD-001, in Meibomian Gland Dysfunction (MGD). This includes new, long-term data at ASCRS of the company’s lead drug candidate, AZR-MD-001, showing improvement in both signs and symptoms in MGD and Contact Lens Discomfort (CLD). Data from 10 abstracts will be featured at the upcoming annual meetings for the American Society of Cataract and Refractive Surgery (ASCRS), April 5-8 in Boston, and the Association for Research in Vision and Ophthalmology (ARVO), May 5-9 in Seattle.

“Together, the data set we are presenting at these prestigious conferences show multiple potential patient benefits and mild, transient side effects in a topical medicine, supporting the potential of AZR-MD-001 as an entirely new approach targeting the underlying cause of many ocular surface diseases,” said Marc Gleeson, Chief Executive Officer of Azura. “We look forward to initiating our Phase 3 trial in Q2 2024 and working with investigators and patients to advance our goal of bringing symptom relief to people burdened by MGD and associated ocular surface conditions.”

Affecting about 100 million people in the U.S.,^5,6,7,8 MGD is a chronic and progressive condition characterized by abnormal keratin production, leading to blocked glands, impacting the quality and quantity of meibum secretions in the upper and lower eyelids. This causes inflammatory ocular surface conditions, ocular surface dryness, pain, irritation, and reduced quality of vision. It is also a leading cause of Dry Eye Disease and a contributor to CLD.^5,6

“With the data to be presented at ASCRS and ARVO, it’s encouraging to see AZR-MD-001 has the potential to improve the signs and symptoms of MGD for up to six months, with clinically meaningful improvements for people living with the progressive condition,” said Julie Schallhorn, M.D., M.S., ophthalmologist at University of California, San Francisco Health. “These data further support that by opening up blocked glands and improving the quality of the tear film, many downstream ocular surface conditions such as dry eye disease and contact lens discomfort may be resolved.”

Details for the poster presentations are as follows:

ASCRS sessions:

ARVO sessions:

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 which can result in glandular atrophy.⁴ It is a leading cause of Dry Eye Disease (DED) and a contributor to Contact Lens Discomfort.^5,6 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. Severe DED is associated with an increased risk of corneal ulcers and ocular infections. Approximately 30-40 million people are diagnosed with MGD in the U.S., with the total prevalent population estimated at 100 million Americans.^1,2,3,4

About Contact Lens Discomfort

Contact Lens Discomfort (CLD) is a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, that can lead to decreased wear time and discontinuation of contact lens use. CLD patients experience symptoms of ocular discomfort (e.g., dryness, irritation, discomfort, fatigue) that increase in severity over the day while the patient is wearing the contact lenses. CLD remains a major reason for discontinuation of contact lens use despite years of research into optimizing lens design and materials for the ocular environment. There are currently more than 140 million contact lens wearers worldwide and studies report that between 12% and 51% of lens wearers ‘‘drop out’’ of contact lens wear, citing CLD as the primary reason for discontinuation.⁸

About AZR-MD-001

Azura’s lead clinical-stage, investigational drug candidate AZR-MD-001 harnesses the power of selenium sulfide (SeS2) in an ophthalmic ointment preparation applied directly to the meibomian glands in the lower eyelid. It is transferred to the meibomian glands in the upper eyelid when the patient blinks. AZR-MD-001 is thought to have a multi-modal mechanism of action that treats the pathophysiology of MGD along with the resulting ocular surface symptoms.⁹ 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 quality and quantity of meibum produced by the meibomian glands.⁹

AZR-MD-001 is currently being studied to evaluate the safety, efficacy, and tolerability of the study drug in patients with clinical signs of MGD. This product has not been approved by the FDA.

About Azura Ophthalmics, Ltd.

Azura Ophthalmics is utilizing our deep understanding of ocular surface diseases and drug development to deliver a potential 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 X.

¹ MGD Prevalence: Molinari, J. F., & Stanek, S. (2000). Meibomian gland status comparison between active-duty personnel and US veterans. Military medicine, 165(8), 591-593.

² Hom, M.M. (1990) Prevalence of meibomian gland dysfunction. Optom Vis Sci, 67(9), 710-712.

³ Blackie C. A. Prevalence of meibomian gland dysfunction – a systematic review and analysis of published evidence. (2019) Investigative Ophthalmology and Visual Science – ARVO Abstract Issue. 60(9).

⁴ MGD Screening: American Optometric Association; Azura Primary Research.

⁵ 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.

⁶ Foulks GN, Bran AJ. Meibomian gland dysfunction: a clinical scheme for description, diagnosis, classification, and grading. Ocul Surf. 2003;1:107-126.

⁷ 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.

⁸ 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.

⁹ Data on File.

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