A registration study for AZRMD- 001 – a topical ointment for ophthalmic use that would be applied to the lower lid margin before bedtime to treat meibomian gland dysfunction (MGD), is to commence in 14 sites across Australia and New Zealand in Q1 2021.
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.
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 MGD 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, 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.”
