Azura Ophthalmics Enrolls First Patient in Phase 3 Clinical Trial for AZR-MD-001 in Patients with MGD

Azura Ophthalmics announced that the first patient has been enrolled in the ASTRO study—a phase 3 clinical trial assessing the efficacy and safety of AZR-MD-001 in patients with clinical signs and symptoms of meibomian gland dysfunction (MGD).

"AZR-MD-001 has already demonstrated efficacy against a variety of clinical endpoints indicating that the product has the potential to improve the signs and symptoms of MGD for up to 6 months,” Francis Mah, MD, Director of Cornea and External Disease and Co-Director, Refractive Surgery at Scripps Clinic Medical Group, La Jolla, California, said in a company news release. “The ASTRO study, the second confirmatory efficacy study, will reveal important additional new findings on the use of AZR-MD-001 as a foundational treatment for MGD, and I look forward to learning more about the potential of this ophthalmic keratolytic to restore meibomian gland function in patients.”

The phase 3 ASTRO trial is a multicenter, double-masked, vehicle-controlled, randomized trial to evaluate the efficacy, safety, and tolerability of AZR-MD-001 sterile ophthalmic ointment 0.5% compared to vehicle in patients with abnormal meibomian gland function and associated symptoms of DED. Approximately 500 patients will be dosed twice weekly at bedtime for up to 12 months. Following a screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio. Study follow-up visits will be conducted on day 14, month 1.5, month 3, month 4.5, month 6, month 9, and month 12. Patients will exit the study approximately 13 months after the baseline visit. Any ongoing treatment-emergent adverse events at month 12 will be followed for an additional 30 days.

Primary study endpoints:

• The primary efficacy sign is the change from baseline to month 3 in meibomian glands yielding liquid secretion (MGYLS; 0 to 15 scale) which counts the number of glands secreting liquid meibum.
• The primary efficacy symptom is the change from baseline to month 3 in the total Ocular Surface Disease Index7 (OSDI©) score (0 to 100 scale).

Secondary endpoint:

• Change from baseline to month 3 in Standard Patient Evaluation of Eye Dryness (SPEED) score (0 to 28 scale).

Secondary objectives of the study are to evaluate the ability of AZR-MD-001 to improve additional sign and symptom measures, compared to vehicle and to evaluate the safety and tolerability of AZR-MD-001 applied to the lower eyelid twice-weekly through month 12.