First patient enrolled in phase 3 study of AZR-MD-001 for MGD
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Azura Ophthalmics announced that the first patient has been enrolled in the phase 3 ASTRO study of AZR-MD-001 for patients with clinical signs and symptoms of meibomian gland dysfunction.
“The first patient enrolled in the phase 3 ASTRO study brings us one step closer to potentially providing optometrists with access to AZR-MD-001 in a clinical setting,” Marc Gleeson, the company’s CEO, told Healio. “If approved, AZR-MD-001 would become the first and only ophthalmic keratolytic designed to treat [meibomian gland dysfunction (MGD)] by fixing the problem at the source, which improves the quality of meibomian secretions and restores the function of the meibomian glands to rejuvenate the lid margins.”
According to a company press release, AZR-MD-001 “harnesses the power of selenium sulfide” in a sterile ophthalmic ointment applied directly to the meibomian glands in the lower eyelid. The investigational drug candidate is designed to break down the bonds between abnormal keratin proteins and softens glandular blockage, boosting the quantity and quality of meibum produced.
The multicenter, double-masked ASTRO trial will enroll approximately 500 participants, who will be dosed twice weekly before bed for up to 12 months. Participants will be randomly assigned in a 1:1 ratio to AZR-MD-001 or vehicle, with follow-up visits on day 14 and months 1.5, 3, 4.5, 6, 9 and 12.
The primary endpoints of the study are changes in meibomian glands yielding liquid secretion and Ocular Disease Surface Index score from baseline to month 3, while the secondary endpoint is change in Standard Patient Evaluation of Eye Dryness score during that time.
“Our goal at Azura is to bring symptom relief to people burdened by MGD and associated ocular surface diseases and to restore the function of the meibomian glands,” Gleeson told Healio. “We anticipate the ASTRO trial results will add to the growing body of evidence demonstrating AZR-MD-001’s potential as a safe and effective treatment for patients.”
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