A Phase 3, Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Efficacy, Safety, and Tolerability of AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Associated Symptoms of Dry Eye Disease (DED)

This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.

Start Date28 May 2024

Sponsor / Collaborator

Azura Ophthalmics Ltd.

[+1]

NCT05548491

/ CompletedPhase 2

A Two Stage, Multi-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 and to Determine Common Symptoms in Contact Lens Discomfort (CLD)

A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.

Start Date10 Nov 2022

Sponsor / Collaborator

Azura Ophthalmics Ltd.

[+1]

NCT04391959

/ CompletedPhase 2

A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Start Date17 Jul 2020

Sponsor / Collaborator

Azura Ophthalmics Ltd.

[+1]

100 Clinical Results associated with AZR-MD-001

100 Translational Medicine associated with AZR-MD-001

100 Patents (Medical) associated with AZR-MD-001

Literatures (Medical) associated with AZR-MD-001

01 Oct 2025·Ocular Surface

AZR-MD-001 0.5% selenium sulfide ophthalmic ointment for the treatment of contact lens discomfort: A vehicle-controlled, randomized, clinical trial

Article

Author: Tan, Jacqueline ; Jones, Lyndon ; Hinds, Mark ; Bosworth, Charles ; Alster, Yair ; Chalmers, Robin ; Stapleton, Fiona

BACKGROUND:

Contact lens discomfort (CLD) is a common problem for CL wearers, and patients with CLD often have changes in meibomian gland function and structure. In a Phase 2 trial AZR-MD-001 0.5% (AZR) ophthalmic ointment improved meibomian gland dysfunction (MGD) in non-lens wearers. The current study evaluated the efficacy and safety of AZR in participants with CLD and concomitant MGD.

METHODS:

Adults with CLD (Contact Lens Dry Eye Questionnaire-8 >12, range 0-37) and MGD (Meibomian Gland Secretion Score [MGS] ≤12, range 0-45) were randomized (1:1) to AZR:vehicle applied twice-weekly in a three-month multicenter, prospective, double-masked study. Endpoints included difference in change from baseline (CFB) in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS), MGS, the ability to wear their lenses as long as desired, and safety.

RESULTS:

At Month 3, AZR (n = 34) significantly increased the MGYLS and MGS versus vehicle (n = 33), with least squares mean difference (LSMD) CFB in MGYLS of 5.0 (SE = 0.47) for AZR and 1.6 (0.45) for vehicle, P < 0.0001; MGS of 13.8 (SE = 0.67) for AZR and 3.8 (SE = 0.68) for vehicle, P < 0.0001. Significantly more participants treated with AZR were able to wear lenses as long as desired (43% vs. 6%, P = 0.0023). The most common treatment-emergent adverse event (TEAE) was eye irritation (61.8% AZR; 0% vehicle). All TEAEs related to treatment were mild/moderate, transient, and did not result in discontinuation.

CONCLUSION:

AZR-MD-001 0.5% significantly improved MGD signs and hours of comfortable CL wear, demonstrating good efficacy, safety, and tolerability in those with CLD.

01 Apr 2025·Ocular Surface

The effect of a biweekly novel selenium sulfide-containing topical treatment in symptomatic contact lens wearers: An exploratory study

Article

Author: DePuy, Venita ; Gleeson, Marc ; Jia, Tianni ; Bosworth, Charles ; Stapleton, Fiona ; Tan, Jacqueline

PURPOSE:

To explore effects of topical 1 % selenium sulfide on signs and symptoms in symptomatic contact lens-wearers, in an exploratory 4-month prospective placebo-controlled double-masked randomised trial.

METHODS:

Symptomatic wearers (Contact Lens Dry Eye Questionnaire-8 [CLDEQ-8] score>12) with meibomian gland dysfunction (meibomian gland score (MGS)≤12), were enrolled and received either active (AZR-MD-001-containing 1 % selenium sulfide), or vehicle ointment, to the lower eyelid margin twice-weekly. MGS, meibomian glands-yielding liquid secretion (MGYLS), lipid layer thickness, tear meniscus height, tear break-up time, tear evaporation rate, lid wiper epitheliopathy, CLDEQ-8 and comfortable wear time (CWT) were measured at baseline and to 4-months. Differences between active and placebo were compared to baseline.

RESULTS:

Fourteen participants (5M:9 F, 30.8 ± 13.8 years) completed the study. In the active group, change in MGS from baseline improved by 1-month (mean difference 7.9 ± 8.0, p = 0.03), to 4-months (16.0 ± 11.3, p < 0.01). MGYLS improved from baseline by 1.5-months (4.0 ± 3.3) to 4-months (4.1 ± 4.3, p < 0.01). In the vehicle, change in MGS (12.1 ± 10.7) and MGYLS (3.9 ± 3.2) were improved at 4-months only (p < 0.01). CLDEQ-8 score improved at 1-month and 4-months compared to baseline (-4.4 ± 3.2, -5.1 ± 4.7, p ≤ 0.02) in the active and at 4-months only in the vehicle group (-4.4 ± 6.4, p = 0.02). In the active group, CLDEQ-8 visual function scores improved at 1- and 4-months (p ≤ 0.02) and CWT at 4-months (median 7 vs.10 h, p = 0.025). Other signs were unchanged.

CONCLUSIONS:

This exploratory study indicates that twice-weekly use of AZR-MD-001 ointment can rapidly improve gland patency and secretion in symptomatic contact lens-wearers. AZR-MD-001 reduced changeable/blurry vision and prolonged CWT, suggesting relevant future endpoints.

22 Jan 2025·EXPERT OPINION ON PHARMACOTHERAPY

An update on emerging pharmacological treatments for meibomian gland dysfunction

Review

Author: Coco, Giulia ; Giannaccare, Giuseppe

INTRODUCTION:

Meibomian Gland Dysfunction (MGD) represents the most common cause of dry eye disease (DED). Traditional treatments mainly rely on heating and liquifying the meibum to favor its expression. However, recent knowledge advances have led to the development of novel therapies specifically designed for patients with MGD.

AREAS COVERED:

Literature search was conducted on current and novel treatments for MGD. Conventional treatment strategies, non-pharmacological approved device-based therapies, approved dry eye therapies and both recently approved and emerging pharmacological treatments specifically designed to address MGD are discussed.

EXPERT OPINION:

The better understanding of MGD and DED pathophysiology has allowed to develop drugs able to target the primary mechanisms of the disease. Miebo has been the first FDA approved drug for patients with DED associated with MGD and its ability to reduce the tear film layer evaporation rate and the minimal impact on the quality of vision are important innovations. Great expectations also accompany the phase 3 study of AZR-MD-001, understood to be a keratolytic and lipogenic agent able to improve meibum quantity and quality. The chance to specifically target MGD represents an important step forward and will allow more tailored treatment for each type of ocular surface disease.

News (Medical) associated with AZR-MD-001

10 Dec 2025

·www.businesswire.com

Azura Ophthalmics Corporate Update: AZR-MD-001 NDA Submission Expected in 2H 2026

TEL AVIV, Israel--(BUSINESS WIRE)--Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing AZR-MD-001, an investigational, potentially first-in-class, Ophthalmic Keratolytic targeting Meibomian Gland Dysfunction (MGD), today announced that it has received positive feedback from a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) confirming that the company’s existing clinical development program for AZR-MD-001 is sufficient to support its planned NDA submission. “We are very encouraged by the FDA’s feedback and pleased by their determination that our existing clinical data package satisfies the requirements for a sign and symptom in two adequate and well-controlled confirmatory efficacy studies,” said Marc Gleeson, CEO of Azura Ophthalmics. “We believe AZR-MD-001 has the potential to redefine how patients with Meibomian Gland Dysfunction and Dry Eye Disease are treated by directly targeting gland function with a novel, easy-to-administer, twice-weekly ophthalmic ointment. As a company, we are focused on submitting our NDA package in the second half of 2026.” The FDA confirmed the CELESTIAL and ARIES study data fulfill the regulatory efficacy requirements for approvability of AZR-MD-001 for the treatment of the signs and symptoms of Dry Eye Disease (DED). The results from these two studies demonstrate statistically significant improvement in a sign, Meibomian Glands Yielding Liquid Secretion (MGYLS), and symptomatic benefit in Ocular Surface Disease Index (OSDI©) in CELESTIAL and increased comfortable contact lens wear time in ARIES. The FDA indicated that the safety database across CELESTIAL, ARIES, and ASTRO is sufficient for submission, with long-term safety data from the ongoing ASTRO study expected to be shared in Q1 2026, further supporting the application. The company believes that AZR-MD-001’s robust product profile, including its unique triple mechanism of action, keratolytic, keratostatic, and lipogenic, supports its differentiation from existing DED therapies. AZR-MD-001 is administered directly to the lower eyelid margin twice weekly at bedtime. It is designed to restore meibomian gland function, improve tear stability, and reduce symptoms associated with DED, including Contact Lens Discomfort (CLD). “We continue to see growing recognition among physicians that AZR-MD-001 addresses meibomian gland obstruction, an important and previously untreated root cause of Dry Eye Disease,” said Dr. Francis Mah, Director of Cornea and External Disease and Co-Director, Refractive Surgery at Scripps Clinic Medical Group, La Jolla, Calif. “A product that can open and restore gland function with a convenient, twice-weekly dose could be practice-changing for millions of patients.” AZR-MD-001 is an investigational drug candidate and has not been approved by the U.S. FDA. To date, over 500 patients have been treated with AZR-MD-001 in clinical trials, and the product appears to be safe and well-tolerated. About Meibomian Gland Dysfunction (MGD) Meibomian Gland Dysfunction (MGD) is a chronic and progressive condition that affects the quality and flow of meibum from the meibomian glands. MGD is a leading cause of Dry Eye Disease (DED). Without treatment, MGD may lead to glandular dropout and increased ocular surface damage, which reduces quality of vision and decreases quality of life. Current therapies for DED primarily focus on inflammation or tear production and do not address the underlying glandular dysfunction that characterizes MGD. About CELESTIAL1,2 CELESTIAL, a multicenter, vehicle-controlled, randomized study to evaluate the safety, tolerability, systemic pharmacokinetics, and pharmacodynamics of AZR-MD-001 in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED) was a parallel group study of AZR-MD-001 (0.5% and 1.0%) and vehicle in a 1:1:1 ratio, dosed twice-weekly in the evening (at bedtime). Patients were followed for a total of 6 months. The pre-specified primary efficacy endpoints were Meibomian Glands Yielding Liquid Secretion (MGYLS) and total Ocular Surface Disease Index (OSDI©) change from baseline to Month 3. About ARIES3 ARIES was a multi-center, vehicle-controlled study to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 and to determine common symptoms in patients with Dry Eye Disease (DED) characterized by signs of Meibomian Gland Dysfunction (MGD) and an inability to wear their contact lenses as desired. Patients were treated with either AZR-MD-001 0.5% and vehicle in a 1:1 ratio, dosed twice-weekly in the evening (at bedtime). Patients with DED were challenged with Contact Lens Wear and were followed for a total of 3 months. The primary efficacy sign endpoint was Meibomian Glands Yielding Liquid Secretion (MGYLS), and the symptom endpoint was Comfortable Contact Lens Wear Time in hours. About ASTRO ASTRO, a phase 3, multicenter, vehicle-controlled, randomized study to evaluate the efficacy, safety, and tolerability of AZR-MD-001 in patients with abnormal meibomian gland function and associated symptoms of Dry Eye Disease (DED), is an ongoing parallel group study of AZR-MD-001 0.5% and vehicle randomized in a 1:1 ratio. The study drug is dosed twice-weekly to the lower eyelid in the evening (at bedtime). The study objective supporting the New Drug Application (NDA) is to evaluate the safety and tolerability of AZR-MD-001 sterile ophthalmic ointment 0.5% or vehicle dosed twice-weekly through Month 12. About AZR-MD-001 AZR-MD-001 is the first and only Ophthalmic Keratolytic investigational therapy in development as a foundational treatment for Meibomian Gland Dysfunction (MGD), a leading cause of Dry Eye Disease (DED). Delivered as a twice-weekly selenium sulfide ointment applied to the lower eyelid margin, AZR-MD-001 is designed to restore meibomian gland function by improving the quality and quantity of meibum, rejuvenating the lid margins, and alleviating evaporative dry eye symptoms. The therapy’s unique triple mechanism of action, keratolytic, keratostatic, and lipogenic, targets the root cause of MGD. About Azura Ophthalmics Azura Ophthalmics (“Azura”) is utilizing its deep understanding of ocular surface diseases and drug development to deliver a potential new therapeutic class of Ophthalmic Keratolytics to treat underserved ophthalmic conditions. The company’s differentiated approach combines ophthalmologic and dermatologic science to harness the unique properties of keratolytics for the treatment of Dry Eye Disease (DED) by targeting Meibomian Gland Dysfunction (MGD) and other ocular diseases. Azura’s pipeline of internally discovered new chemical entities represents a portfolio of potentially first-in-class ophthalmic therapeutics for significant unmet needs. For more information, visit www.azuraophthalmics.com and follow Azura on LinkedIn. References Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, et al. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-46. Downie LE, Craig JP, Stapleton F, Tan J, Jones LW, Ng A, et al. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction over six months of treatment: A Phase 2, vehicle-controlled, randomized extension trial. Ocul Surf. 2025 Jan:35:15-24. Stapleton F, Hinds M, Tan J, Jones L, Chalmers R, Bosworth C, Alster Y. AZR-MD-001 0.5% selenium sulfide ophthalmic ointment for the treatment of contact lens discomfort: A vehicle-controlled, randomized, clinical trial. Ocul Surf. 2024 Dec 28:S1542-0124(24)00144-7.

Clinical ResultPhase 3Phase 2NDA

04 Jun 2024

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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: 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. . 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.

Phase 3

28 Mar 2024

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Azura Ophthalmics to Present New Data Supporting the Potential of AZR-MD-001 to be the First Ophthalmic Keratolytic for Ocular Surface Diseases

Azura to present 10 abstracts at the American Society of Cataract and Refractive Surgery (ASCRS) and the Association for Research in Vision and Ophthalmology (ARVO), showcasing a breadth of data supporting the potential for a new therapeutic class to treat underserved ophthalmic conditions New and updated data show investigational AZR-MD-001 demonstrates durability of response in improving ocular signs and symptoms of Meibomian Gland Dysfunction (MGD) after six months of treatment 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: Abstract title Abstract presentation details Correlation of Patient Outcomes with Indicators of Meibomian Gland Dysfunction Following Treatment with AZR-MD-001 Session Date & Time: April 6 1:30-1:35 p.m. EDT Presenter: Julie Schallhorn, M.D., M.S. Location: BCEC - Meeting Level 2, Room 259B Improvement in Ocular Signs and Symptoms of Meibomian Gland Dysfunction (MGD) after 6 Months of AZR-MD-001 Treatment Session Date & Time: April 8, 9:10-9:15 a.m. EDT Presenter: Preeya Gupta, M.D. Location: BCEC - Meeting Level 2, Room 259B ARVO sessions: Abstract title Abstract presentation details AZR-MD-001 Improved Corneal and Conjunctival Damage in Patients with CLD and MGD Posterboard number: B0505 Session Date & Time: May 6, 3:00-4:45 p.m. PDT Presenter: Charles Bosworth, Azura Ophthalmics Location: Exhibit Hall - Seattle Convention Center AZR-MD-001 Opens Meibomian Glands, Improves Meibum and Tear Quality Resulting in Increased Wear Time and Desired Lens Use in Patients With CLD Posterboard number: B0513 Session Date & Time: May 6, 3:00-4:45 p.m. PDT Presenter: Lyndon Jones, Ph.D. Location: Exhibit Hall - Seattle Convention Center AZR-MD-001 Efficacy in Resolving the Signs and Associated Symptoms of Contact Lens Discomfort in a Phase 2 Trial Posterboard number: A0130 Session Date & Time: May 7, 8:30-10:15 a.m. PDT Presenter: Mark Hinds Location: Exhibit Hall - Seattle Convention Center Validity of the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and its comprehensiveness in assessing disease impact after the widespread adoption of digital media in patients with Contact Lens Discomfort (CLD) and concomitant Meibomian Gland Dysfunction (MGD) Posterboard number: B0315 Session Date & Time: May 9, 8:00-9:45 a.m. PDT Presenter: Robin Chalmers, O.D., F.A.A.O. Location: Exhibit Hall - Seattle Convention Center Safety and Efficacy of Topical AZR-MD-001 for the Treatment of Meibomian Gland Dysfunction in a 6-Month Study Posterboard number: B0265 Session Date & Time: May 9, 2:00-3:45 p.m. PDT Presenter: Jacqueline Tan, Ph.D. Location: Exhibit Hall - Seattle Convention Center Sign and Symptom Improvement Rates Among MGD Patients Following Treatment With AZR-MD-001 for 6 Months Posterboard number: B0269 Session Date & Time: May 9, 2:00-3:45 p.m. PDT Presenter: Julie Schallhorn, M.D., M.S. Location: Exhibit Hall - Seattle Convention Center AZR-MD-001 Improved Tear Film Stability and Ocular Symptoms in Patients with Meibomian Gland Dysfunction: 6-Month Results Posterboard number: B0270 Session Date & Time: May 9, 2:00-3:45 p.m. PDT Presenter: Joshua C. Teichman, M.D., M.P.H., F.R.C.S.C. Location: Exhibit Hall - Seattle Convention Center AZR-MD-001 Ophthalmic Ointment Opens Meibomian Glands, Improves Meibum Quality, and Tear Film Stability Over 3 Months of Dosing in Patients with Contact Lens Discomfort Posterboard number: B0271 Session Date & Time: May 9, 2:00-3:45 p.m. PDT Presenter: Fiona Stapleton, Ph.D. Location: Exhibit Hall - Seattle Convention Center 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: 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. . 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.

Clinical ResultPhase 2Phase 3

100 Deals associated with AZR-MD-001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dry Eye Syndromes	Phase 3	United States	Azura Ophthalmics Ltd.	28 May 2024
Meibomian Gland Dysfunction	Phase 3	Australia	Azura Ophthalmics Ltd.	14 Jul 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06329791 (AZ202401, ARVO2025)	Phase 3	Meibomian Gland Dysfunction	562	AZR-MD-001 0.5%	gmzdimuzys(vibilyzuui) = bltkiyfawh kdveqpdapk (wilfwubxii, 3.1) View more	Positive	04 May 2025
NCT03652051 (AZR-MD-001, ARVO2024)	Phase 2	Meibomian Gland Dysfunction	245	AZR-MD-001 0.5%	jtfiihhery(vcdzeeegui) = rvnhtelvae sxkuxxbkuw (qvinutiaps, 0.46) View more	Positive	05 May 2024
				AZR-MD-001 1.0%	jtfiihhery(vcdzeeegui) = pamdbdpqpg sxkuxxbkuw (qvinutiaps, 0.45) View more
NCT05548491 (AZR-MD-001, ARVO2024)	Phase 2	Chronic lung disease \| Meibomian Gland Dysfunction	67	AZR 0.5% ophthalmic ointment	pvcffwgttv(zrrdblohxi) = xngnwcbkjn txptwsfjnr (nvktzasiyc ) View more	Positive	05 May 2024
				Vehicle	pvcffwgttv(zrrdblohxi) = douqbjyhau txptwsfjnr (nvktzasiyc ) View more
NCT05548491 (AZR-MD-001, ARVO2024)	Phase 2	-	67	AZR 0.5%	jkrqtdvnsu(hjrpejaeip) = axcjwrsuub vfophjjwsl (yzhqdzhttb, 0.46) View more	Positive	05 May 2024
				Vehicle	jkrqtdvnsu(hjrpejaeip) = qjjsysitjp vfophjjwsl (yzhqdzhttb, 0.47) View more
NCT05548491 (AZR-MD-001, ARVO2024)	Phase 2	-	67	AZR 0.5%	bzkrjvxyla(vhddzmlmbo) = ousutjwquz jzumfkowkd (iywyaufjbx ) View more	Positive	05 May 2024
				Vehicle	bzkrjvxyla(vhddzmlmbo) = yiudynwdur jzumfkowkd (iywyaufjbx ) View more
NCT05548491 (AZR-MD-001, ARVO2024)	Phase 2	-	67	AZR 0.5%	pgxzdrjkkg(prkyetscut) = maajuaaqxg vkxgunszzn (nnzxrsipkq ) View more	Positive	05 May 2024
				Vehicle	pgxzdrjkkg(prkyetscut) = vdmbshjqlg vkxgunszzn (nnzxrsipkq ) View more
NCT03652051 (AZR-MD-001, CTgov)	Phase 2	Dry Eye Syndromes \| Meibomian Gland Dysfunction	321	AZR-MD-001 (Stage 1: AZR-MD-001 Low Dose)	rgtlolctby(vtluzoaapu) = ckiudyjmjo elbroslssn (idvbjldhge, 1.56) View more	-	28 Feb 2024
				AZR-MD-001 (Stage 1: AZR-MD-001 Mid Dose)	rgtlolctby(vtluzoaapu) = gqgjcoxhpn elbroslssn (idvbjldhge, 0.8) View more
NCT05548491 (Biospace) Manual	Phase 2	Meibomian Gland Dysfunction	67	AZR-MD-001 0.5%	iicdtjdsbf(rextaixlja) = ewowyfapod pkdxcmzpts (vshcmlmxmk ) View more	Positive	18 Dec 2023
				Vehicle	iicdtjdsbf(rextaixlja) = jhjumjokee pkdxcmzpts (vshcmlmxmk ) View more
NCT03652051 (ARVO2023)	Phase 2	Meibomian Gland Dysfunction	-	AZR-MD-001 ophthalmic ointment, 0.5%	npuoopjpoo(euhpotbmon) = firaphfxch dbcczdmsou (jdkryonqvy ) View more	Positive	23 Apr 2023
				AZR-MD-001 ophthalmic ointment, 1.0%	npuoopjpoo(euhpotbmon) = qpdjdbazmp dbcczdmsou (jdkryonqvy ) View more
AZR-MD-001 (ARVO2023)	Phase 2	Meibomian Gland Dysfunction	-	AZR-MD-001 0.5% ophthalmic ointment	npjkptajoh(dhovcdimwj) = iqbeasooss qrrcbwfocp (imjmqqcpje ) View more	Positive	23 Apr 2023
				AZR-MD-001 1.0% ophthalmic ointment	npjkptajoh(dhovcdimwj) = myshbejngq qrrcbwfocp (imjmqqcpje ) View more

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