AZR-MD-001

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.

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: 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. . 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