The Association for Research in Vision and Ophthalmology (ARVO 2023) Publication

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

Posterboard#: B0072

Abstract Number: 5175 – B0072

AuthorBlock: Preeya Gupta1,2, Laura Elizabeth Downie3, Mark Hinds4, Yair Alster5, Charles Bosworth5

1Ophthalmology, Triangle Eye Consultants, Raleigh, North Carolina, United States; 2Ophthalmology, Tulane University, New Orleans, Louisiana, United States; 3Optometry and Vision Science, The University of Melbourne, Melbourne, Victoria, Australia; 4Research, Opthalmic Trials Australia, Brisbane, Queensland, Australia; 5Research, Azura Ophthalmics Limited, Tel Aviv, Israel;

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

Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details.
Meibomian gland dysfunction and its associated symptoms is a major contributor to adverse ocular surface effects, including blepharitis, corneal defects, contact lens discomfort, and dry eye disease. Dry eye disease is a common, costly condition which causes sufferers to experience uncomfortable eyes and blurry vision. Severe dry eye affects 10-20% of the population over 40 and sufferers experience reduced quality of life and significant out-of-pocket treatment costs and there is no permanent cure. A novel eye ointment containing selenium sulphide, used twice a week for 90 days in adults with meibomian gland dysfunction, caused the signs and symptoms of the disease to resolve in almost half of the patients. This degree of improvement is considerable compared with existing treatments and this is a promising advance for sufferers of this common, chronic disease.

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