Azura Ophthalmics announced a $20 million financing to advance Azura’s lead product candidate AZR-MD-001 through a registration study for the treatment of meibomian gland dysfunction (MGD).
Azura’s novel medicines in development are designed to address abnormal hyperkeratinization – the build-up and shedding of the proteins at the opening of the Meibomian gland or within the gland itself – known to be the root cause of obstructive MGD. This approach has been used safely and effectively for decades in dermatology and is based on the understanding that Meibomian glands share strong similarities with sebaceous glands, skin glands responsible for conditions like acne, including the ability to undergo keratinization, according to a company news release.
“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,” Preeya K. Gupta, MD, clinical medical director of Duke Eye Center at Page Road and associate professor of ophthalmology at Duke University Eye Center, said in a company news release. “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 is a topical ointment applied to the lower lid that has shown a positive safety and efficacy profile in several studies in MGD. Based on these data and interactions with the FDA, the company plans to proceed to registration studies in 2021.
“We are thrilled to enter 2021 with the additional funding that will allow us to conduct the 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, 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.”