Azura Ophthalmics raises $28m for registration studies for treatment of leading cause of dry eye disease

MELBOURNE, Australia and TEL AVIV, Israel, Oct. 23, 2020 /PRNewswire/ -- Azura Ophthalmics Ltd., a clinical-stage company developing innovative therapies for Meibomian gland dysfunction (MGD) and related eye diseases, today announced a US$28m raise. The round included participation from existing investors, including, Brandon Capital's Medical Research Commercialisation Fund (MRCF), OrbiMed, TPG Biotech, and Ganot Capital.

On the back of encouraging Phase 2 data, proceeds from the funding round will be used to advance Azura's lead product candidate AZR-MD-001 into 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.

Registration studies are the final stage before potential Food and Drug (FDA) regulatory approval. The first study will be carried out at 14 sites across Australia and New Zealand in the first quarter of next year.

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, North Carolina. "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 effectiveness profile in several early-stage studies in MGD. Based on these data and interactions with the U.S. Food and Drug Administration (FDA), the company will use the funds from the financing to advance AZR-MD-001 into a registration study and seek potential regulatory approval.

"We are thrilled to enter 2021 with the additional funding that will allow us to conduct the registration 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, Sydney-based 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."

"On the back of positive Phase 2 data in patients with MGD, the investor syndicate are delighted to be providing this additional funding to support the progression of Azura's lead asset into a registration clinical study," said Dr Chris Nave, CEO of the MRCF and Managing Director of Brandon Capital "In addition to its lead candidate AZR-MD-001, the company has a strong pipeline and we have great confidence in the management team's ability to progress these promising products into clinical development and ultimately commercialization."

"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. 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 (Selenium Disulfide) 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 US. 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.

About the Medical Research Commercialisation Fund (MRCF) and Brandon Capital Partners

Brandon Capital Partners is a venture capital firm that manages the Medical Research Commercialisation Fund (MRCF), Australia and New Zealand's largest life science investment fund. The MRCF is a unique collaboration between major Australian superannuation funds, the Australian and New Zealand governments, Australian state governments and more than 50 leading medical research institutes and research hospitals. The MRCF supports the development and commercialisation of early-stage biomedical discoveries originating from member research organisations, providing both capital and expertise to guide the successful development of new therapies. The MRCF has supported more than 45 start-up companies to date, most of which were founded by the MRCF.

For more information about the MRCF visit: https://www.mrcf.com.au/

For more information about Brandon Capital Partners visit: www.brandoncapital.com.au