Study met its primary endpoint and showed significant and clinically meaningful improvements in multiple symptoms of Contact Lens Discomfort and signs of concomitant Meibomian Gland Dysfunction

Patients in the AZR-MD-001 arm gained at least three hours of comfortable contact lens wear time daily and had improvements in both tear break up time and ocular surface staining

Azura is advancing AZR-MD-001 into Phase 3 studies

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 positive topline efficacy and safety results from a Phase 2 study of AZR-MD-001 in patients with Contact Lens Discomfort (CLD) who could not comfortably wear their lenses as desired and who demonstrated signs of Meibomian Gland Dysfunction (MGD). The trial met its primary endpoint of showing a statistically significant improvement in Meibomian Glands Yielding Liquid Secretion (MGYLS; number of open glands).

The study also met additional secondary and clinically meaningful endpoints, including significant improvements in meibum quality (measured by Meibomian Gland Score, MGS); tear stability (measured by tear break up time, TBUT); ocular surface staining (measured by both fluorescein and lissamine green staining); and contact lens wear time. AZR-MD-001 was safe and well tolerated. All observed adverse events were mild to moderate in severity and none resulted in treatment discontinuation. This is the second positive Phase 2 study of AZR-MD-001 to demonstrate statistically significant improvements across multiple sign and symptom endpoints in patients with MGD.

“MGD is the root cause of many downstream ocular surface conditions that impact quality of life and vision for patients, including Contact Lens Discomfort. By opening up blocked glands and improving the quality of the tear film, we believe many of these ocular surface conditions can be resolved,” said Marc Gleeson, Chief Executive Officer of Azura. “In addition to meeting its primary MGYLS endpoint, we are especially encouraged that AZD-MD-001 allowed patients who had given up using contacts to wear their contacts again – safely and comfortably – for an additional three hours every day over their normal wear time. We now have two studies showing AZR-MD-001 can improve the signs and symptoms of MGD and we look forward to discussing these results with the FDA as we advance our Phase 3 development program.”

MGD is a chronic condition that causes the glands in the eyelids to become blocked, impacting the quality and quantity of meibum secretions in the upper and lower eyelids. This leads to several downstream ocular surface symptoms including dryness, pain, irritation, reduced quality of vision, and Contact Lens Discomfort. Many patients who have signs of ocular surface disease including MGD and who would like to wear contact lenses find they cannot wear them for as long as desired and may stop using contact lenses if wearing them becomes too bothersome or uncomfortable.

“MGD is one of the causes of Contact Lens Discomfort, and many patients give up on wearing contact lenses altogether due to the irritation they experience. Innovation in contact lens design and materials intended to offer a more comfortable patient experience has stalled, with reports of discomfort at the end of the day being similar for the past 20 years. This leaves patients frustrated and seeking alternative vision correction options,” said Lyndon Jones, Ph.D., Director and Professor at the Centre for Ocular Research & Education in Ontario, Canada. “With these AZR-MD-001 data, I’m encouraged to see a potential treatment that may address the underlying cause of Contact Lens Discomfort, and I believe my patients would find an extra three hours of comfortable contact lens wear time to be very meaningful.”

About the Contact Lens Discomfort Study (ClinicalTrials.gov ID NCT05548491)

The Phase 2 trial was a multi-center, vehicle-controlled study that evaluated the safety and efficacy of AZR-MD-001 0.5% compared to its vehicle in 67 patients diagnosed with Contact Lens Discomfort who could not comfortably wear their contact lenses as desired and who had signs of MGD. Patients self-administered AZR-MD-001 or its vehicle to the lower eyelid at bedtime twice weekly for 3 months. The prospectively defined primary efficacy endpoint was the number of open glands as measured by the MGYLS score. Secondary endpoints included comfortable contact lens wear time reported in minutes, corneal and conjunctival staining using the Oxford scale, and responder analyses based upon published thresholds for MGYLS and MGS. The trial was supported by a clinical stream (Medical Research Future Fund ESTAC) grant from CUREator, a biotechnology incubator run by Brandon BioCatalyst to support and accelerate the development of Australian biomedical research and innovations.

AZR-MD-001 0.5% achieved statistically significant differences compared to vehicle in both signs and symptoms at month 3:

• Primary endpoint:
  • Significant improvements in MGYLS score, with patients experiencing significantly more open glands on AZR-MD-001 than vehicle (5.0 glands vs 1.6 glands, p<0.0001).
• Secondary endpoints:
  • Significantly more patients treated with AZR-MD-001 had at least 5 more glands opened, as measured by MGYLS responder rate, compared to vehicle (58.2% vs 6.1%, p< 0001).
  • Significantly more patients treated with AZR-MD-001 had their meibum quality return to normal levels, as measured by MGS responder rate, compared to vehicle (97.1% vs. 33.6%, p<0.0001).
  • Comfortable contact lens wear time increased by 192 minutes for AZR-MD-001 treated patients compared to 0.65 minutes for vehicle treated patients (p<0.0001).
  • AZR-MD-001 significantly decreased fluorescein and lissamine green ocular surface staining:
    • AZR-MD-001 was associated with a significant shift toward lower fluorescein staining scores with 67.1% of patients achieving a score of 0 compared to 15.2% of patients treated with vehicle (p=0.0001).
    • AZR-MD-001 was associated with a significant shift toward lower nasal lissamine green staining scores with 32.4% of patients achieving a score of 0 compared to 18.1% of patients treated with vehicle (p=0.0038).
    • AZR-MD-001 was associated with a significant shift toward lower temporal lissamine green staining scores with 35.5% of patients achieving a score of 0 compared to 12.1% of patients treated with vehicle (p=0.0205).

All Treatment-Emergent Adverse Events (TEAEs) were mild to moderate with no serious treatment-related AEs. No patients discontinued the study due to adverse events.

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.¹

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 end in gland atrophy. It is a leading cause of Dry Eye Disease and contributor to Contact Lens Discomfort.^2,3 MGD is commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in glandular secretion.⁴ 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 Dry Eye Disease. Severe DED is associated with an increased risk for corneal ulcers and ocular infections. Approximately 30-40 million people are diagnosed with MGD in the United States, with the total prevalent population estimated at 100 million Americans.^5,6,7,8

About AZR-MD-001

Azura’s lead clinical-stage, investigational drug candidate AZR-MD-001 harnesses the power of selenium sulfide (SeS₂) in an easy-to-use ophthalmic ointment preparation applied directly to the meibomian glands in the lower eyelid. 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. 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.

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.

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 X.

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 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.

⁵ 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.

⁶ Hom, M.M. (1990) Prevalence of meibomian gland dysfunction. Optom Vis Sci, 67(9), 710-712.

⁷ 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).

⁸ MGD Screening: American Optometric Association; Azura Primary Research

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