AZR-MD-001 efficacy in resolving the signs and associated symptoms of meibomian gland dysfunction (MGD) in a phase 2 trial: responder status analysis

Abstract

Purpose : MGD is considered the root cause of most evaporative dry eye disease and a key driver of ocular surface symptoms, with no FDA-approved medications for treatment as yet. These analyses from a Phase 2 study identified the percentage of participants with resolution of signs and ocular symptoms in response to topical applications of AZR-MD-001 (0.5% or 1.0% ophthalmic ointment) in adult patients with MGD

Methods : This Phase 2 prospective, multi-center, randomized, double-masked, vehicle-controlled, parallel design trial included participants aged 18 and older with mild-to-moderate MGD and its associated ocular symptoms. Participants were screened and randomized into three treatment groups (AZR-MD-001 ophthalmic ointment, 0.5% or 1.0%, or vehicle). Therapy 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 by OSDI and clinical signs evaluated according to MGS (Meibomian Gland Score) and MGYLS (Meibomian Glands Yielding Liquid Secretion), measures for meibum quality and gland functionality, respectively. Responder rates included the percentage of asymptomatic participants in each group according to established cutoffs

Results : More participants in the AZR-MD-001 0.5% and 1.0% treatment groups than control group (vehicle) achieved resolution in signs and symptoms across all measures at day 90. These changes were demonstrated by a significant increase in number of functional glands (MGYLS≥5; 0.5% =46%, 1.0%=29%, vehicle=15%), good meibum quality (MGS>12; 0.5%=69%, 1.0%=51%, vehicle=44%) and the proportion of patients measured as asymptomatic (OSDI<13; 0.5%=47%, 1.0%=38%, vehicle=28%) at Day 90. Significantly higher rates of response were observed for the AZR-MD-001 0.5% group compared to vehicle as early as day 45, including number of open glands and meibum quality (p<0.01, respectively)

Conclusions : This Phase 2 study showed a higher percentage of participants treated with AZR-MD-001 experiencing resolution of MGD signs and symptoms compared to vehicle. This is the first therapeutic medication to demonstrate significant rates of resolution of clinical signs of MGD and associated ocular symptoms, with a promising impact on patients affected by this condition

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