A registration study for AZR-MD-001 – a topical ointment for ophthalmic use that would be applied to the lower lid margin before bedtime to treat meibomian gland dysfunction, is to commence in 14 sites across Australia and New Zealand.
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
Developed by clinical-stage company Azura Ophthalmics, AZR-MD-001 leverages Selenium Disulfide (SeS2) as the active ingredient, which 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
The registration study follows encouraging Phase 2 data and is the final stage before potential Food and Drug Administration (FDA) regulatory approval.
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.
“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 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 has raised AU$28 million 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.”
The first study will commence in Australia and New Zealand in the first quarter of next year.
- 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.
- U.S. Census