Azura Ophthalmics Announces Enrollment of First Patient in Phase 3 Clinical Trial for AZR-MD-001 in Patients with Meibomian Gland Dysfunction (MGD)

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 that the first patient has been enrolled in the ASTRO study – a Phase 3 clinical trial assessing the efficacy and safety of AZR-MD-001 in patients with clinical signs and symptoms of Meibomian Gland Dysfunction (MGD).

Affecting about 100 million people in the U.S.,^1,2,3,4 MGD is a chronic and progressive condition associated with blockage of the meibomian glands, impacting the quality and quantity of meibum secretions in the upper and lower eyelids. The condition causes inflammatory ocular surface conditions, ocular surface dryness, pain, irritation, and reduced quality of vision. MGD is also a leading cause of Dry Eye Disease (DED) and a contributor to Contact Lens Discomfort (CLD).^5,6

“AZR-MD-001 has already demonstrated efficacy against a variety of clinical endpoints indicating that the product has the potential to improve the signs and symptoms of MGD for up to six months,” said Dr. Francis Mah, Director of Cornea and External Disease and Co-Director, Refractive Surgery at Scripps Clinic Medical Group, La Jolla, California. “The ASTRO study, the second confirmatory efficacy study, will reveal important additional new findings on the use of AZR-MD-001 as a foundational treatment for MGD, and I look forward to learning more about the potential of this ophthalmic keratolytic to restore meibomian gland function in patients.”

About the ASTRO (Assessment of Secretions and Treatment for Restoring Ocular surface health in patients with Meibomian Gland Dysfunction) Trial

The Phase 3 trial is a multicenter, double-masked, vehicle-controlled, randomized trial to evaluate the efficacy, safety, and tolerability of AZR-MD-001 sterile ophthalmic ointment 0.5% compared to vehicle in patients with abnormal meibomian gland function and associated symptoms of DED. Approximately 500 patients will be dosed twice weekly at bedtime for up to 12 months. Following a screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio. Study follow-up visits will be conducted on day 14, month 1.5, month 3, month 4.5, month 6, month 9, and month 12. Patients will exit the study approximately 13 months after the baseline visit. Any ongoing treatment-emergent adverse events at month 12 will be followed for an additional 30 days.

Primary study endpoints:

• The primary efficacy sign is the change from baseline to month 3 in meibomian glands yielding liquid secretion (MGYLS; 0 to 15 scale) which counts the number of glands secreting liquid meibum.
• The primary efficacy symptom is the change from baseline to month 3 in the total Ocular Surface Disease Index⁷ (OSDI^©) score (0 to 100 scale).

Secondary endpoint:

• Change from baseline to month 3 in Standard Patient Evaluation of Eye Dryness (SPEED) score (0 to 28 scale).

Secondary objectives of the study are to evaluate the ability of AZR-MD-001 to improve additional sign and symptom measures, compared to vehicle and to evaluate the safety and tolerability of AZR-MD-001 applied to the lower eyelid twice-weekly through month 12.

“We are pleased to enroll the first patient in our U.S.-based Phase 3 clinical trial which we anticipate will add to the growing body of evidence demonstrating AZR-MD-001’s potential as a safe and effective treatment for patients,” said Marc Gleeson, Chief Executive Officer of Azura. “We look forward to working with investigators and patients in advancing our goal of bringing symptom relief to people burdened by MGD and associated ocular surface conditions.”

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 (CLD).^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 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.⁸ It breaks down the bonds between abnormal keratin proteins to soften glandular blockage, slows down the production of keratin to prevent future blockages, and increases the quality and quantity of meibum produced by the meibomian glands.⁸

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 and symptoms of DED. This product has not been approved by the U.S. 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 represents 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.

References:
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, 6(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 Ocular Surface Disease Index (OSDI) Version 1; © 1995 Allergan, All Rights Reserved.
⁸ Data on File.

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