Significant improvement in multiple measures of Meibomian gland secretion and associated improvements in contact lens wear time

TEL AVIV, Israel & MELBOURNE, Australia--(BUSINESS WIRE)--Azura Ophthalmics Ltd., a clinical-stage company developing innovative therapies for Meibomian gland dysfunction (MGD) and related eye diseases, today announced topline results from a phase 2 clinical trial evaluating the company�s investigational therapy for the treatment of contact lens discomfort (CLD). The ECLIPTIC study examining Azura�s lead asset, AZR-MD-001, met its primary endpoints by showing statistically significant improvements in multiple measures of Meibomian gland secretion and patients� ability to wear contact lenses as desired. Full data from the study will be submitted for presentation at an upcoming scientific meeting.

The ECLIPTIC study is a single-center, single-masked, vehicle-controlled, randomized, parallel group study that evaluated the safety, tolerability and pharmacodynamics of AZR-MD-001 in 26 patients with CLD at The University of New South Wales. Primary endpoints included the assessment of meibum gland secretion score (MGS), number of Meibomian glands yielding liquid secretion (MGYLS), Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and comfortable wear time. The study compared twice-weekly therapy with a 1.0% dose of AZR-MD-001 to vehicle.

Topline results from the ECLIPTIC study demonstrated significant improvements in MGS with AZR-MD-001 1.0% after 14 days of treatment (Mean � SE; 3.4 (1.64), P < 0.05). The MGS continued to improve until the study was completed (14.3 (3.05), p < 0001). There were no clinically significant differences in MGS in the vehicle treated group. Additionally, AZR-MD-001 1.0% reached statistical superiority over vehicle after 1.5 months of treatment and beyond. Similar trends were observed with MGYLS, which also reached statistical superiority over vehicle after 1.5 months of treatment and beyond. In patients treated with AZR-MD-001 1.0%, there were significant improvements reported in their contact lens comfort as early as month 1.

�We are excited by the results of the ECLIPTIC study, which validate the potential of our dermatological approach and suggest that ophthalmic keratolytics could be an effective treatment option for the millions of patients who experience contact lens discomfort,� said Marc Gleason, CEO of Azura. �Azura is committed to bringing the first medicine indicated for the treatment of contact lens discomfort to market � and to help us reach this goal, we plan to convene an expert panel in 2021 with leading specialists from around the world. We look forward to sharing the full data next year and advancing AZR-MD-001 through a registration study.�

Azura�s novel, lead medicine in development, AZR-MD-001, leverages SeS2 (Selenium Disulfide) as the active ingredient to treat CLD. AZR-MD-001 is a topical ointment applied to the lower lid designed to address abnormal hyperkeratinization � the build-up and shedding of the proteins at the opening of the Meibomian gland or within the gland itself � known to be the root cause of MGD. MGD is one of the most common causes of CLD, a condition known to impact more than 20 million adults in the U.S. alone.^1,2,3

�These findings demonstrate the potential clinical benefits of the innovative medicines Azura is developing, the role abnormal keratin protein aggregation plays within the meibum and how this translates into the pathology we see in these clinical conditions,� said Dr. Fiona Stapleton, Scientia Professor, School of Optometry and Vision Science, and Associate Dean, Enterprise, Faculty of Science, at The University of New South Wales, who initiated the study. �There is a significant need for a novel treatment approach for contact lens discomfort and related conditions. A therapeutic that can restore the normal flow of Meibomian gland secretions has the potential to benefit a broad population of patients, and could change how we approach the treatment of ocular surface disease.�

About Contact Lens Discomfort

Contact lens discomfort (CLD) is one of the most highly prevalent conditions among contact lens wearers, impacting more than 20 million adults in the U.S.¹ Contact lenses can put stress on the tear film, which weakens and alters the lipid layer.^3,4 As a result, contact lens wearers experience Dry Eye Disease (DED) symptoms like persistent pain, irritation or changes in vision, leading to reduced lens-wearing time or complete discontinuation. MGD is one of the most common causes of symptomatic CLD.^2,5, There are currently no approved therapies for CLD.⁵

About AZR-MD-001

Azura Ophthalmics has a robust clinical development pipeline including SeS2 (Selenium Disulfide). The company�s pipeline of new chemical entities is in pre-clinical through phase 2 development for a number of ocular and lid margin diseases, including MGD, acute use for MGD, inflammatory/aqueous deficient Dry Eye, blepharitis, CLD and ocular manifestations of graft-versus-host disease (GvHD).

Azura�s lead product candidate, AZR-MD-001, is a topical ointment that has been developed to yield properties ideal for ophthalmic use. The formulation is applied to the lower lid margin before bedtime. Azura is currently evaluating the safety, tolerability and effectiveness of AZR-MD-001, developed for ophthalmic use, in phase 2 trials in patients with MGD, evaporative DED and CLD.

AZR-MD-001 leverages SeS2 as the active ingredient. SeS2 has a triple mechanism of action: it slows down keratin production; breaks down the bonds between abnormal keratin proteins; and increases the quantity of lipid produced by the Meibomian glands. If approved, AZR-MD-001 will be a first-in-class ophthalmic keratolytic for the treatment of lid margin diseases, starting with MGD and CLD.

About Azura Ophthalmics, Ltd.

Azura Ophthalmics is a clinical-stage company headquartered in Tel Aviv-Yafo, Israel with operations in Australia and the U.S. The company is developing an innovative portfolio of compounds to advance treatments for MGD, the leading cause of DED. By targeting the root cause of MGD, Azura brings the promise of improved health and well-being to millions of people worldwide who suffer from MGD and other ocular surface diseases where treatment options are currently lacking. Azura is underpinned by an experienced management team with an established track record of successfully developing and commercializing novel treatments for ocular surface diseases. For more information visit: www.azuraophthalmics.com and follow Azura on LinkedIn.

¹Solomon A. Allergic manifestations of contact lens wearing. Curr Opin Allergy Clin Immunol. 2016;16(5):492-7.

²Milner, 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

³Foulks GN, Bron AJ. Meibomian gland dysfunction: a clinical scheme for description, diagnosis, classification, and grading. Ocul Surf. 2003;1:107-126.

⁴Hom MM. Use of cyclosporine 0.05% ophthalmic emulsion for contact lens-intolerant patients. Eye Contact Lens. 2006;32(2):109-11.

⁵Nichols, J. J., Willcox, M. D., Bron, A. J., Belmonte, C., Ciolino, J. B., Craig, J. P., Dogru, M., Foulks, G. N., Jones, L., Nelson, J. D., Nichols, K. K., Purslow, C., Schaumberg, D. A., Stapleton, F., Sullivan, D. A., & members of the TFOS International Workshop on Contact Lens Discomfort (2013). The TFOS International Workshop on Contact Lens Discomfort: executive summary. Investigative ophthalmology & visual science, 54(11), TFOS7�TFOS13. https://doi.org/10.1167/iovs.13-13212

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