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Tuesday / May 18.
HomeminewsPositive Results for Potential Dry Eye Disease Treatment

Positive Results for Potential Dry Eye Disease Treatment

Azura Ophthalmics has moved into registration studies following positive Phase 2 Program results that could see its treatment for meibomian gland dysfunction – the leading cause of dry eye disease – complete its first registration study by early next year.

The Phase 2 Program found that 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.

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.

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

AZR-MD-001 is designed to restore meibomian gland function by addressing the abnormal hyperkeratinisation that blocks the glands, alters the quality of the oil and prevents the secretion of lipids into the tears

Azura has commenced a registration study across 12 clinical research centres in Australia and New Zealand which will most likely be completed by early 2022. Registration studies are the final stage before potential Food and Drug (FDA) regulatory approval.

Azura raised AU$28m last October to finance the registration study and FDA registration process. The round included participation from existing investors, including, Brandon Capital’s Medical Research Commercialisation Fund (MRCF), OrbiMed, TPG Biotech, and Ganot Capital.

Research shows that MGD is the main cause of dry eye disease. Current treatment options for dry eye disease are primarily focused on treating inflammation and providing temporary relief with artificial tears, which only account for a minority of the dry eye disease population. AZR-MD-001 is designed to restore meibomian gland function by addressing the abnormal hyperkeratinisation 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.

“Though there are approved treatments for dry eye disease, they are only appropriate for the patients where inflammation is the cause of the disease,” said Edward Holland, M.D., Director, Cornea Services/Professor of Clinical Ophthalmology, Cincinnati Eye Institute/University of Cincinnati. “Research shows that 86% of people with dry eye disease exhibit signs of meibomian gland dysfunction.1 By addressing the underlying cause of meibomian gland dysfunction that leads to dry eye, Azura is taking an entirely different approach to the disease that has the potential to benefit a much broader population of patients.”

Mr Gleeson noted that Australia’s effective handling of the Covid-19 pandemic meant Azura’s clinical trial program has been able to continue relatively undisrupted, which would not have been possible if trials were being 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.

“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.”

About the Phase 2 Program

The program was a multi-centre, double-masked, vehicle-controlled integrated analyses of four phase 2 studies that evaluated the safety and efficacy of AZR-MD-001 (0.1%, 0.5% and 1.0%) in 95 patients with MGD. Patients were dosed twice weekly at night time. Primary endpoints included patient-reported symptoms as measured by the Ocular Surface Disease Index (OSDI) score, the quality of fluid secretion as measured by the Meibomian Gland Score (MGS) and the number of glands secreting meibum as measured by the Meibomian Glands Yielding Liquid Secretion (MGYLS) score.

There was a statistically significant and clinically meaningful reduction of symptoms as measured by a reduction in OSDI score in the two highest doses tested (0.5% and 1.0%) compared to baseline and control:

  • Statistically significant improvements from baseline were observed in both the 0.5% and 1.0% dose groups (p<0.01) with significant improvements over control observed by Month 3 in the 0.5% group (p<0.05).
  • Up to 58% of patients became non-symptomatic (score of <13) after three months of treatment compared to 16% of patients in the control arm (p<0.05).

Similar trends were observed in the secondary endpoint of patient-reported symptoms as measured by the Standardised Patient Evaluation of Eye Dryness (SPEED) Questionnaire. Results demonstrated a statistically significant difference from baseline and control in the 1.0% dose group (p<0.05) and a statistically significant change from baseline in the 0.5% dose group (p<0.05) and compared to control (p<0.08).

Results also indicated a clear dose-response in the number of glands secreting meibum as measured by a statistically significant improvement in MGYLS score in the two highest doses tested (0.5%, 1.0%) compared to baseline and control:

  • Statistically significant increases from baseline were observed in both the 0.5% and 1.0% dose groups (p<0.01) with significant improvements over control observed as early as Month one with 1.0% (p<0.01) and continuing to Month three (p<0.01).
  • Up to 46% of patients achieved a clinically meaningful increase in MGYLS compared to 8% of patients in the control arm (p<0.01).

Additionally, results further indicated a clear dose-response in the quality of meibum secreted as measured by a statistically significant improvement in MGS in both dose groups (0.5%, 1.0%) compared to baseline and in the highest dose tested (1.0%) compared to control:

  • Statistically significant increases from baseline were observed in both the 0.5% and 1.0% dose groups (p<0.01) with significant improvements over control observed as early as Month two with 1.0% (p<0.05) and continuing to Month three (p<0.01).
  • Up to 59% of patients returned to a normal range (score of >12) after three months of treatment compared to 31% of patients on control (p<0.05)

AZR-MD-001 was well tolerated with no serious ocular treatment emergent adverse events (TEAEs). The most common TEAEs were application site irritation, stinging upon application, and watery eyes, which only occurred in patients in the 1.0% dose group.

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