-- Lead clinical asset AZR-MD-001 for Meibomian gland dysfunction to advance through registration study

-- Meibomian gland dysfunction is the leading cause of Dry Eye Disease, a condition known to affect more than 30 million adults in the United States alone

-- Financing also will support development of pipeline of new chemical entities in pre-clinical through Phase 2 development for other significant ocular surface conditions

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 a US$20 million financing. The round was led by a syndicate of existing investors including OrbiMed, TPG Biotech, Brandon Capital’s Medical Research Commercialization Fund (MRCF) and Ganot Capital.

On the back of encouraging Phase 2 data to date proceeds from the funding round will be used to advance Azura’s lead product candidate AZR-MD-001 through a registration study for the treatment of MGD – an eye condition where the Meibomian glands become dysfunctional, resulting in rapid evaporation of the tear film.

Azura’s novel medicines in development are 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 obstructive MGD. This approach has been used safely and effectively for decades in dermatology and is based on the understanding that Meibomian glands share strong similarities with sebaceous glands, skin glands responsible for conditions like acne, including the ability to undergo keratinization.

Meibomian gland dysfunction is the leading cause of evaporative Dry Eye Disease, a condition known to affect more than 30 million adults in the United States alone presenting a huge unmet need globally.1,2

“The current options we have to treat patients with Meibomian gland dysfunction focus primarily on relieving obstruction and have not focused on the role of keratin within meibum. There are millions of patients with ocular surface disease and MGD worldwide; we need better treatments to help our symptomatic patients,” said Dr. Preeya K. Gupta, clinical medical director of Duke Eye Center at Page Road and associate professor of ophthalmology at Duke University Eye Center. “The promise of Azura’s dermatological approach lies in its ability to open the glands, increase lipid production and restore tear-layer health, as well as preventing disease progression in patients with Meibomian gland dysfunction.”

Azura’s lead compound AZR-MD-001 is a topical ointment applied to the lower lid that has shown a positive safety and efficacy profile in several studies in MGD. Based on these data and interactions with the U.S. Food and Drug Administration (FDA), the company plans to proceed to registration studies in 2021.

“We are thrilled to enter 2021 with the additional funding that will allow us to conduct the studies needed to build a strong body of clinical evidence for our approach, so we can seek FDA approval for the first ophthalmic keratolytics for the treatment of Meibomian gland dysfunction,” said Marc Gleeson, CEO of Azura. “We are grateful for the support of our investors who share our conviction that Azura’s medicines in development have the potential to transform treatment and provide hope to millions of patients suffering from unresolved eye conditions.”

“The investor syndicate believes in Azura and in its team’s ability to bring promising ocular products through approval and ultimately commercialization. The company is led by strong repeat entrepreneurs and industry veterans who have proven astute and resourceful in constructing an elegant pipeline and executing on efficient yet robust trials that have enabled swift progress,” said Dr. Chris Nave, managing director at Brandon Capital. “The investor syndicate is committed to continuing to support the advancement of Azura’s innovative pipeline as they create medicines to target Meibomian gland dysfunction and related conditions that impact the ocular health of millions of people around the world.”

About Meibomian Gland Dysfunction

Meibomian gland dysfunction (MGD) is the leading cause of Dry Eye Disease (DED), a condition known to affect more than 30 million adults in the United States alone.1,2 MGD is a chronic, diffuse abnormality of the Meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion.3 There are no approved prescription pharmaceutical agents that specifically treat these glandular changes. If left untreated, MGD will alter the tear film, resulting in damage to the front of the eye and severe discomfort from associated ocular surface diseases. Though there are treatments on the market for ocular surface diseases, many patients still suffer from dry eye, and research shows that hyperkeratinization of the Meibomian glands is the underlying cause of the disease.4 There are currently no approved medicines for MGD.

About AZR-MD-001

Azura Ophthalmics has a robust clinical development pipeline investigating the reformulated, prescription-strength SeS2 (Selenium Disulfide). The company has a pipeline of new chemical entities in pre-clinical through Phase 2 development for a number of ocular and lid margin diseases, including Meibomian gland dysfunction, acute use for Meibomian gland dysfunction, Inflammatory/Aqueous Deficient Dry Eye, Blepharitis, contact lens discomfort 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 would be 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 a Phase 2 study in patients with MGD and evaporative DED.

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 Meibomian gland dysfunction and contact lens discomfort.

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.

1 Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the beaver dam offspring study: prevalence, risk factors, and health-related quality of life. Am J Ophthalmol. 2014;157(4):799–806.

2 U.S. Census

3 Nichols et al. The International Workshop on Meibomian Gland Dysfunction: Executive Summary IOVS, Special Issue 2011, Vol. 52, No. 4

4 Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78.

Contacts

Health+Commerce Sierra Smith sierra@healthandcommerce.com 408.540.4296