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 positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD), were presented for the first time at Ophthalmology Innovation Summit XII (OIS) on Saturday, December 3, 2022 in San Diego, California.

“Azura’s positive Phase 2b data signal a key step forward in our advancement of AZR-MD-001 for the development of a therapeutic treating the root cause of MGD and resulting ocular surface symptoms,” said Marc Gleeson, Chief Executive Officer of Azura. “With MGD impacting an estimated 100 million Americans,^1,2 AZR-MD-001 has the potential to bring relief to a large patient population in need of innovative treatment options. It was a pleasure to share our exciting Phase 2b results at OIS XII, and we look forward to advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.”

The results from Azura’s Phase 2b study of AZR-MD-001 0.5% in MGD were presented during the “Spotlight on Dry Eye” session at OIS XII. The recorded presentation is available for viewing on the News & Events section of Azura’s website.

About the Phase 2b 3-Month Results

The Phase 2b trial was a multi-center, double-masked, vehicle-controlled, parallel group study that evaluated the safety and efficacy of AZR-MD-001 in 245 patients with MGD. Patients administered AZR-MD-001 twice weekly to the lower eyelid at bedtime. The prospectively defined co-primary efficacy endpoints included the number of glands secreting meibum as measured by the Meibomian Glands Yielding Liquid Secretion (MGYLS) score and patient-reported symptoms as measured by the Ocular Surface Disease Index^©3 (OSDI^©) score.

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

• Co-primary
  • Significant improvements in MGYLS score, with patients experiencing an average increase of 1.8 more open glands secreting meibum from baseline (p = 0.0004).
  • Significant improvements in OSDI score, with patients reporting an average improvement of 3.5 from baseline (p = 0.0438).
• Key Secondary
  • 46.9% of patients became asymptomatic as measured by Total OSDI responder rate.
  • 45.7% of patients had at least 5 more glands opened from baseline of 1.7, as measured by MGYLS responder rate.
  • 68.7% of patients had their meibum quality return to normal levels, as measured by MGS responder rate.

Additional patient-reported outcomes, using well established questionnaires, also demonstrated statistically significant improvements for AZR-MD-001 0.5% from baseline:

• Significant improvements in SPEED (p<0.0001) and Average VAS (visual analogue scale) (p<0.0001).
• Significant improvements in Eye Discomfort (p<0.0001), Eye Dryness (p<0.0001) and Ocular Itch (p<0.0001).

The majority of Adverse Events (AEs) were mild and transient with no serious treatment-related AEs. The number of subjects with treatment emergent AEs leading to discontinuation was 2.4% for AZR-MD-001 0.5%.

About Meibomian Gland Dysfunction

Meibomian Gland Dysfunction 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 the leading cause of Dry Eye Disease and Contact Lens Discomfort.^4,5 MGD is commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion.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 Dry Eye Disease, resulting in corneal ulcers and ocular infections.

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 in the lower eyelid. AZR-MD-001 is thought to have a multi-modal mechanism of action that treats the pathophysiology of Meibomian Gland Dysfunction 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 MGD. Azura expects to initiate a second pivotal multi-center clinical trial of AZR-MD-001 0.5% in 2023.

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

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

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

4. 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.

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

6. 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.