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Aussie-based MGD trial advances towards FDA approval   

Australia’s relative success at managing COVID-19 has meant an overseas biotechnology company can forge ahead with the final phase of clinical trials before its meibomian gland dysfunction (MGD) therapy is considered by US regulators.

Azura Ophthalmics, headquartered in Tel Aviv-Yafo, Israel, with operations in Australia and the US, could complete its first registration study of AZR-MD-001 by early 2022, following positive Phase 2 results announced this month.

Marc Gleeson.

AZR-MD-001 is designed to restore MGD – which research shows is the main cause of dry eye disease – by addressing the abnormal hyperkeratinization that blocks the glands, alters the quality of the oil and prevents the secretion of lipids into the tears. The therapy is in the form of a topical ointment applied to the lower lid margin twice a week before bedtime.

Azura has now commenced a registration study – the final stage before potential US Food and Drug Administration (FDA) regulatory approval – across 12 clinical research centres in Australia and New Zealand.

Mr Marc Gleeson, CEO of Azura, said Australia’s effective handling of the COVID-19 pandemic has meant the company’s clinical trial program could continue relatively undisrupted, which would not have been possible if trials were conducted in the US or Europe.

“Meibomian gland dysfunction is a debilitating disease which has a terrible impact on millions of peoples’ lives around the world. Our goal is to get our treatment registered for use, as quickly as possible, and Australia’s management of the pandemic has meant little disruption to our clinical trial program,” he said.

“Clinical trial recruitment and participation are at normal levels across Australia and New Zealand, something few countries can boast. Trials in Australia have high enrolment rates, in part because contract research organisations offer incentives for citizens to participate and the Australian government promotes clinical trials among consumers and health care providers, making it easy to get involved.”

The company said it raised AU$28 million last October to finance the registration study and FDA registration process. Contributions from existing investors included Brandon Capital’s Medical Research Commercialisation Fund (MRCF), overseas supporters OrbiMed, TPG Biotech, and Ganot Capital.

Brandon Capital Partners is a venture capital firm that manages the MRCF, Australia and New Zealand’s largest life science investment fund. The MRCF is a 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.

Phase 2 results

Azura’s Phase 2 program found AZR-MD-001 showed improvements with two doses (0.5% and 1.0%). Statistically significant improvement in signs and symptoms of MGD were demonstrated relative to the control arm, according to the company.

After three months of treatment, 58% and 42% of patients in the 0.5% and 1.0% dose groups, respectively, became non-symptomatic, compared to 16% of patients in the control arm, as measured against the Ocular Surface Disease Index, a patient symptom score used by clinicians.

Gleeson said the positive results point to a potential first-in-class treatment for patients with MGD.

“We are thrilled by the positive results showing a statistically significant and clinically meaningful improvement in the signs and symptoms of meibomian gland dysfunction, which validates our multi-mechanism of action and suggests that AZR-MD-001 has the potential to be a first-in-class treatment option for patients with Meibomian gland dysfunction,” he said.

“The study findings also provide insight into the target populations, appropriate dosing and endpoints for our registration study.”

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