Azura Ophthalmics Obtains Grant to Evaluate AZR-MD-001 for Improved Quality of Vision Related to Contact Lens Discomfort

TEL AVIV, Israel and MELBOURNE, Australia–(BUSINESS WIRE)–Azura Ophthalmics Ltd. (Azura), a clinical-stage biopharmaceutical company developing a novel therapeutic class of ophthalmic keratolytics for ocular surface diseases, today announced that the company has received a grant from CUREator, Australia’s national biomedical incubator run by Brandon BioCatalyst. The grant will support Azura’s two-stage study evaluating the safety, tolerability and efficacy of the company’s lead clinical candidate, AZR-MD-001, in patients with contact lens discomfort (CLD ) who show signs of meibomian gland dysfunction (MGD).

“We are delighted to receive this CUREator grant and believe it serves to validate our differentiated approach of combining ophthalmology and dermatology solutions to harness the properties of keratolytics to address the root cause of contact lens discomfort and ‘other ocular surface indications,’ said Marc Gleeson, CEO of Azura Ophthalmics. “Meibomian gland dysfunction is the leading cause of CPD and is directly implicated in the dry eye and discomfort experienced by millions of contact lens wearers.”

Fiona Stapleton, Scientia Professor, School of Optometry and Vision Sciences at the University of New South Wales in Sydney, said: “We are delighted that Azura has been awarded this grant and we look forward to continuing our collaborative evaluation of the AZR-MD-001 for the CLD. Our pilot study met its primary endpoints by showing statistically significant improvements in several measures of meibomian gland secretion and patients’ ability to wear contact lenses as desired.

Background of AZR-MD-001 in patients with CLD

It is estimated that there are 140 million contact lens wearers worldwide and over 44 million wearers in the United States alone. Up to 51% of contact lens wearers ‘drop out’ of contact lens wear citing CLD as the primary reason for discontinuation.1

Azura evaluated AZR-MD-001 (1.0%) ointment as a potential treatment for CPD in a first pilot study: SOVS2019-070 (the ECLIPTIC study). Significant improvements from baseline were observed in meibum gland secretion score (MGS) and number of meibomian glands producing fluid secretion (MGYLS) after treatment with AZR-MD-001 for 3 months (p 2 This impact of AZR-MD-001 on visual function was also found in an integrated Phase 2a analysis in four studies conducted by Azura in patients with MGD. The results of the integrated analyzes indicated significant drug effects on the visual function subscale of the Ocular Surface Disease Index (OSDI).

The significant impact of AZR-MD-001 on visual function observed in the studies is believed to be the result of increased meibum release and/or production. The increased release and/or production of meibum strengthens the lipid layer of the tear film which, in turn, should increase the stability of the precorneal tear film. Given that the precorneal tear film is the first major refractive surface of the eye, this should stabilize visual quality and may explain the observed improvements in patient-reported vision-related outcomes.

About Meibomian Gland Dysfunction

Meibomian gland dysfunction (MGD) is a chronic, progressive condition associated with blockage of the meibomian glands and impaired quality of expressed meibum. It is the main cause of dry eye (DED) and contact lens discomfort (CLD).3.4 MGD is usually characterized by terminal duct obstruction and/or qualitative/quantitative changes in glandular secretion.5 There are no approved prescription pharmaceutical agents that specifically treat these glandular changes. If left untreated, MGD alters the tear film, leading to damage to the front of the eye and severe discomfort from associated ocular surface diseases.

About Contact Lens Discomfort

Contact lens discomfort (CLD) is a condition in which lens wearers experience pain and irritation, causing them to reduce their lens-wearing time or stop wearing them altogether. The use of contact lenses can stress the tear film, leading to instability and alterations in the lipid layer, and can cause an unexpected manifestation of symptoms in patients with mild MGD who are otherwise asymptomatic.6 There are currently no approved pharmacological treatments for CLD and there are no treatments available that can significantly improve the debilitating symptoms associated with CLD such as blurred and fluctuating vision and discomfort.

About AZR-MD-001

Azura’s lead clinical-stage drug candidate, AZR-MD-001, is a topical ointment that has been developed to produce properties ideal for ophthalmic use. The formulation is applied to the lower edge of the eyelid twice a week before bedtime.

AZR-MD-001 uses selenium sulfide (SeS2) as its active ingredient. SeS2 has been identified as an ideal candidate for the treatment of meibomian gland dysfunction (MGD) due to its multi-mechanism of action targeting MGD pathophysiology. It breaks down the bonds between abnormal keratin proteins to soften blockage, slows keratin production to prevent future blockages, and increases the amount of lipids produced by the meibomian glands.

AZR-MD-001 is currently being studied in a Phase 2 trial to evaluate the safety, tolerability, and efficacy of the study drug in patients with MGD and evaporative dry eye (EDD) . Azura expects to release key data in Q4 2022.

About Azura Ophthalmics, Ltd.

Azura Ophthalmics uses its extensive knowledge of ocular surface diseases and drug development to deliver a novel therapeutic class of ophthalmic keratolytics. Our differentiated approach combines ophthalmology and dermatology solutions to harness the unique properties of keratolytics to address the root cause of many underserved ocular indications. Led by our clinical-stage program, initially focused on resolving the signs and dramatically improving the symptoms of Meibomian Gland Dysfunction (MGD), our in-house developed pipeline treats the spectrum of eyelid margin diseases and of the ocular surface. For more information, visit: www.azuraophthalmics.com and follow Azura on LinkedIn.

About CUREator

Delivered by Brandon BioCatalyst, CUREator is supported by the Australian Federal Government’s Medical Research Future Fund. The MRFF’s $80 million Translation and Commercialization Support (ESTAC) grant aims to help companies develop projects that support medical innovation in Australia through to proof of concept and beyond, providing marketing opportunities. CUREator is responsible for managing $40 million of this fund, dedicated to supporting the commercialization of preclinical medical innovations and the early clinical development of therapies.

For more information on CUREator, visit: https://brandonbiocatalyst.com/cureator/

References

1. Nichols JJ, Willcox MDP, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: Summary. Invest Ophthalmol Vis Sci. 2013;54:TFOS7–TFOS13.

2. Stapleton F, Tan J, Jia T, DrPuy V, Gleeson M, and Bosworth C. The effect of a new topical treatment containing sulfide on ocular signs and symptoms in symptomatic contact lens wearers: an exploratory study . Summary ARVO, Inv Ophthal & Vis Sci, 2021; 62:1259.

3. Milner, MS, Beckman, KA, Luchs, JI, Allen, QB, Awdeh, RM, Berdahl, J., Boland, TS, Buznego, C., Gira, JP, Goldberg, DF, Goldman, D., Goyal , RK, Jackson, MA, Katz, J., Kim, T., Majmudar, PA, Malhotra, RP, McDonald, MB, Rajpal, RK, Raviv, T., … Yeu, E. (2017). Dysfunctional tear syndrome: dry eye disease and associated tear film disorders – new diagnostic and treatment strategies. Current Opinion in Ophthalmology, 27 Suppl 1(Suppl 1), 3–47. https://doi.org/10.1097/01.icu.0000512373.81749.b7.

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

5. Efron N, Jones L, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: Report of Contact Lens Interactions with the Ocular Surface and Adnexa Subcommittee. Invest Ophthalmol Vis Sci. 2013;54:TFOS98–TFOS122.

6. Blackie CA, Korb DR, Knop E, Bedi R, Knop N, Holland EJ. Unobvious obstructive meibomian gland dysfunction. Cornea. 2010;29(12):1333-45.

About Marion Alexander

Check Also

Warby Parker Inc. (NYSE: WRBY) Receives Medium “Holding” Rating from Analysts

Shares of Warby Parker Inc. (NYSE: WRBY – Get Rating) received a consensus rating of …