Sign and Symptom Improvement Rates Among MGD Patients Following Treatment With AZRMD001 for 6 Months

Abstract

Purpose : AZRMD001 (AZR), selenium sulfide ophthalmic ointment (0.5% or 1.0% concentration), was investigated for the treatment of meibomian gland dysfunction (MGD). This study determined the responder rates for signs and symptoms in patients with MGD following 6 months of treatment.

Methods : This Phase 2, multicenter, double-masked, vehicle-controlled, parallel-group trial (NCT03652051) randomized patients (1:1:1) to receive AZR (0.5% [n=82] or 1.0% [n=83]) or vehicle (n=80) twice weekly before bedtime for 6 months. Eligible patients were ≥18 years of age and exhibited meibomian gland obstruction (Meibomian Gland Secretion [MGS] score ≤12 for 15 lower lid glands) and an Ocular Surface Disease Index (OSDI) score from 13 to 33. Predefined responder criteria, based on literature thresholds, were: Meibomian Glands Yielding Liquid Secretion (MGYLS) change from baseline ≥5, MGS score >12, and Ocular Surface Disease Index (OSDI) score <13. Analyses included all data through Month 6.

Results : AZR showed a higher percentage of patients with a clinically meaningful improvement in MGYLS (0.5% AZR 59.9%, p=0.0001; 1.0% 43%, p=0.0218; vehicle 22.3%). Significantly more patients randomized to AZR demonstrated normal meibum as early as at Day 14 (0.5% AZR 19.9%, p=0.0380; 1.0% AZR 18.5%, p=0.0949; vehicle 7.6%) and continuing through Month 6 (0.5% AZR 74.4%, p=0.0017; 1.0% AZR 63.2%, p=0.1273; vehicle 48%). By Month 6, significantly more patients treated with AZR were asymptomatic for disease (OSDI <13: 0.5% AZR 48.2%, p=0.0333; 1.0% AZR 50.1%, p=0.0205; vehicle 30%).

Conclusions : Over 6 months, a greater proportion of patients applying both concentrations of AZR-MD-001 demonstrated a clinically meaningful response, with normalization of their meibomian gland function, meibum secretions, and the resolution of disease symptomology.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.