AZR-MD-001 restores gland gunction and improves signs and ocular symptoms of mebomian gland dysfunction (MGD)

Abstract

Purpose : MGD is a common condition that can lead to downstream ocular surface effects, including dry eye disease, blepharitis, corneal defects, and contact lens discomfort. This study investigated the safety and efficacy of topical application of AZR-MD-001 in adults with MGD

Methods : This Phase 2, prospective, randomized, double-masked, vehicle-controlled trial enrolled adult participants with mild to moderate MGD and associated ocular symptoms. Eligible participants (n=245) were randomized (1:1:1) to one of 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 over 90 days. Co-primary outcomes were change from baseline in meibomian gland function (Meibomian Glands Yielding Liquid Secretion, MGYLS) and ocular surface symptoms (Ocular Surface Disease Index, OSDI), compared to vehicle at day 90, and the incidence and severity of adverse events. Additional timepoints included 14- and 45-days post-baseline

Results : Participants in the AZR-MD-001 0.5% group showed significant improvements in signs compared to vehicle (change in MGYLS scores from baseline to day 90 were 4.2 (SEM=0.36) vs 2.4 (SEM=0.34) for the AZR-MD-001 0.5% and vehicle, respectively [p=0.0004]; 3.2 (SEM=0.34) [p=0.1408] for AZR-MD-001 1.0%) and symptoms (change in OSDI from baseline to day 90 were 7.29 (SEM=1.26) vs 3.77 (SEM=1.22) for AZR-MD-001 0.5% and vehicle, respectively [p=0.0438]; 6.11 (SEM= 1.295) for AZR-MD-001 1.0% [p=0.1814]). Significant clinical changes were seen as early as day 14, after a total of four applications of the drug. Adverse events included application site pain, superficial keratitis, corneal staining, eye pain, and increased lacrimation; most were mild to moderate in severity. Discontinuations due to AEs were 2.4% (0.5% dose), 1.2% (1.0% dose) and 0% (vehicle)

Conclusions : This Phase 2 study demonstrated that AZR-MD-001 significantly improved signs and ocular symptoms of MGD compared to vehicle at day 90. Improvements were seen at day 14 after only four medication doses. AZR-MD-001 was safe and well tolerated in this study

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