Azura CEO gives details on phase 2 study of AZR-MD-001

Marc Gleeson, CEO of Azura, sat down with David Hutton, Managing Editor at Ophthalmology Times to discuss the recent positive results from the Phase 2 clinical trial of AZR-MD-001 in patients with contact lens discomfort.

Video Transcript

Editor's note - This transcript, produced using AI, has been edited for clarity.

David Hutton:

I'm David Hutton of Ophthalmology Times, Azure Ophthalmics has announced positive topline efficacy and safety results from a phase two study of AZR-MD-001 in patients with contact lens discomfort. I'm joined today by Azura CEO Marc Gleeson to discuss the results. First, tell us about the key findings from this study.

Marc Gleeson:

Thanks, David. Thanks for the opportunity for sharing the results of our phase two study of AZR-MD-001 in patients with contact lenses discomfort. One of the key findings from this study was that we were able to demonstrate the use of AZR-MD-001 in opening the glands as measured by meibomian gland yield liquid secretion. What we saw was main change of 5 glands over baselin, compared to 1.6 glands in patients who have been treated by the vehicle. And so this reinforced and validated the mechanism of action of 001 as a drug that really targets the underlying cause of meibomian gland dysfunction. What's unique about this study, in this population, is that it's patients who have essentially given up wearing contact lenses.

And they've given up contact lenses, wearing contact lenses, because of the discomfort that's associated with the changes in the ocular surface. And another key secondary endpoint was that we're able to demonstrate that patients were able to increase their comfortable wear time, by a little over three hours. And that's significant and clinically meaningful. And so what that means is that patients who have the potential to improve their comfortable wear time, so that they can wear their contact lenses throughout the whole day. So we're very excited by the results. But it also validates the underlying mechanism of action of 001 as a key target for opening the glands and improving the quality of the meibomian.

David Hutton:

What can you tell us about the mechanism of action?

Marc Gleeson:

So AZR-MD-001 is a keratolytic. It's a ophthalmic ointment of selenium sulfide. It's non-preserve. And it's our understanding and belief that the mechanism of action works by breaking disulfide bonds or breaking the bonds that caused the keratin proteins to become sticky and change the physical chemical properties. So it breaks disulfide bonds, it also slows down the cell replication cycle, and therefore decreasing the rate of future keratin proteins. And also, we believe that it has an impact in lipogenesis and therefore increasing the rate and the production of lipids from the glands. So it's a unique mechanism of action. And it really does target the underlying cause of meibomian gland dysfunction.

David Hutton:

Ultimately, what can this mean for ophthalmologists and the patients they treat?

Marc Gleeson:

Yeah, ultimately, if approved, we hope that this data will allow patients who have stopped wearing their contact lenses due to contact lens discomfort. They'll be able to get a longer, more comfortable wear time. You know, the contact lens industry is about 140 million people around the world who wear contact lenses. And the dropout rate has been fairly consistent over the last 20 years, even though there have been dramatic improvements in biomaterials associated with the development of contact lenses. And so we hope that if approved, this will be a key treatment options for clinicians to allow patients to stay wearing contact lenses for longer.

David Hutton:

And lastly, what's the next step in your research?

Marc Gleeson:

We're anticipating beginning of phase three program for AZR-MD-001 around Q2 of 2024. Look, I think we're very excited by the progress that we're making with 001. It has a very unique mechanism of action, in that it's really addressing the underlying cause of meibomian gland dysfunction, which then leads to a number of downstream effects that affect the ocular surface. And so we think we're well positioned to have a very differentiated product if approved