Azura Ophthalmics announces positive results in phase two program

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Azura Ophthalmics, a clinical-stage company developing innovative therapies for Meibomian gland dysfunction (MGD), has announced positive results from its phase two program. 

MGD, the leading cause of Dry Eye Disease, is a chronic and progressive condition where the glands that line the eyelids become blocked, preventing them from secreting enough oil into the tear film needed to properly lubricate the eye.

Current treatment options are primarily focused on treating inflammation and providing temporary relief with artificial tears.

Azura said its AZR-MD-001 is designed to restore Meibomian gland function by addressing the abnormal hyperkeratinization that blocks the glands, alters the quality of the oil and prevents the secretion of lipids into the tears. There are currently no approved medicines for the treatment of MGD.

The company said the program found that AZR-MD-001 showed improvements with two doses (0.5 per cent and 1.0 per cent).  Statistically significant improvement in signs and symptoms of MGD were demonstrated relative to the control arm, it said.

"As measured against the Ocular Surface Disease Index (OSDI), a patient symptom score used by clinicians, 58% and 42% of patients in the 0.5% and 1.0% dose groups respectively became non-symptomatic after three months of treatment, compared to 16% of patients in the control arm," said the company in a statement.

“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,” said CEO Marc Gleeson.

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

Azura said it has commenced a registration study across 12 clinical research centres in Australia and New Zealand that will most likely be completed by early 2022.