AZR-MD-001 efficacy in improving tear film stability and its impact on associated symptoms of meibomian gland dysfunction in a Phase 2 trial

Abstract

Purpose : Meibomian gland dysfunction (MGD) causes tear film abnormalities and ocular surface symptoms. A Phase 2 clinical trial was conducted to explore tear film function and its impact on ocular symptoms in response to topical applications of AZR-MD-001 (Selenium Sulphide, 0.5% or 1.0% ophthalmic ointment) in adults with MGD.

Methods : This was a Phase 2 prospective, randomized, double-masked, vehicle-controlled trial of subjects aged >18 with mild-to-moderate MGD (Meibomian Gland Secretion score [MGS] ≤12 for 15 glands of the lower lid) and its associated ocular symptoms (Ocular Surface Disease Index, OSDI score 13-33). Participants were randomized into three treatment groups (AZR-MD-001 ophthalmic ointment, 0.5% (n=82) or 1.0% (n=83), or vehicle (n=80)). AZR-MD-001 ointment was applied to the lower lid margin twice per week at bedtime. Study timepoints included baseline and days 14, 45, and 90. Symptoms of MGD were assessed using OSDI, Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and fluorescein tear break up time (TBUT). Results are reported as responder rates, the percentage of participants in each group with normal TBUT (≥10 seconds), normal OSDI score (<13) and the SPEED change from baseline score compared to vehicle.

Results : More participants in the AZR-MD-001 0.5% and 1.0% treatment groups than control group (vehicle) achieved resolution of signs and symptoms at day 90. These changes were demonstrated by a significant increase in tear film stability (TBUT>10 seconds; 0.5% =17.9%, 1.0%=7%, vehicle=1.9%), and the proportion of patients measured as asymptomatic (OSDI<13; 0.5%=47%, 1.0%=38%, vehicle=28%), and eye dryness (SPEED change from baseline; 0.5%=-4.3, 1.0%=-4.1, vehicle=-2.8) at Day 90. Significantly higher rates of response were observed for the AZR-MD-001 0.5% group compared to vehicle (p<0.05).

Conclusions : This study showed a higher percentage of participants treated with AZR-MD-001 experienced resolution of poor tear film stability and symptoms of MGD compared to vehicle. This is the first therapy to demonstrate significant rates of resolution of clinical signs of MGD and ocular symptoms, such that almost 50% of those with mild to moderate MGD had resolution of the downstream effects on symptoms in 90 days. This novel treatment has demonstrated promising benefits for patients affected by this chronic condition.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.