Association for Research in Vision and Ophthalmology

Association for Research in Vision and Ophthalmology

Source:

Downie LE, et al. A multicenter, double-masked, vehicle-controlled, randomized, parallel group clinical trial of AZR-MD-001 (AZR) in individuals with meibomian gland dysfunction. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 1-7, 2021 (virtual meeting).

Disclosures: Downie reports she receives financial support from Azura Ophthalmics.
May 03, 2021
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Ointment improves dry eye symptoms in meibomian gland dysfunction

Source:

Downie LE, et al. A multicenter, double-masked, vehicle-controlled, randomized, parallel group clinical trial of AZR-MD-001 (AZR) in individuals with meibomian gland dysfunction. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 1-7, 2021 (virtual meeting).

Disclosures: Downie reports she receives financial support from Azura Ophthalmics.
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Patients with meibomian gland dysfunction who were treated with an ointment containing selenium sulfide experienced improvement in dry eye symptoms, according to a study.

Laura E. Downie, PhD, BOptom, of the department of optometry and vision sciences at the University of Melbourne, presented the findings on AZR-MD-001 (Azura Ophthalmics) at the virtual Association for Research in Vision and Ophthalmology meeting.

“Meibomian gland dysfunction, or MGD, is recognized as a chronic diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or changes in glandular secretion,” Downie said in her presentation. “Although physical treatments exist to improve meibomian gland function in MGD, it is typically managed with topical pharmacotherapies intended for aqueous deficient dry eye and do not address the underlying causes of MGD.”

In this interim analysis from a multicenter, double-masked, vehicle-controlled, randomized, parallel group clinical trial, researchers included patients with an Ocular Surface Disease Index (OSDI) score of 13 to 33 and a meibomian gland score (MGS) of less than 12. Researchers randomly assigned patients to receive sequentially higher concentrations of AZR (0.1%, nine patients; 0.5%, seven patients; or 1%, seven patients) compared with vehicle (nine patients).

Investigators assessed the change from baseline at month 3 in meibomian glands yielding liquid secretion (MGYLS) and MGS, as well as the change in symptoms using a visual analogue scale and total OSDI over the same time period. They also evaluated safety using adverse event rates.

At month 3, Downie and colleagues observed a minimal clinically important improvement in dry eye symptoms (change in OSDI score 4.5 units) in 22.2% of patients in the vehicle group, 22.2% of patients in the AZR 0.1% group, 57.1% of patients in the AZR 0.5% group and 85.7% of patients in the AZR 1% group (P = .03 for the difference between vehicle and AZR 1%).

Patients in the AZR 1% group also experienced a greater change from baseline in MGS compared with patients in the vehicle group (12.2 ± 2.4 vs. 4.5 ± 2; P = .03). The results in MGYLS were similar to those found in MGS.

The percentage of patients who experienced at least one ocular treatment-emergent adverse event was 44% in the vehicle group, 44% in the AZR 0.1% group, 71% in the AZR 0.5% group and 86% in the AZR 1% group. However, all reported events were transient and did not affect patients’ willingness to continue study participation.

“AZR-MD-001 has potential to be the first effective pharmacotherapy specifically intended for MGD,” Downie said.