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

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

Posterboard#: B0026

Abstract Number: 5129 – B0026

AuthorBlock: Lisa Nijm1,2, Jennifer P. Craig3, Mark Hinds4, Yair Alster5, Charles Bosworth5

1Ophthalmology, Warrenville EyeCare & LASIK, Chicago, Illinois, United States; 2Ophthalmology, University of illinois Eye and Ear Infirmary, Chicago, Illinois, United States; 3Ophthalmology, The University of Auckland New Zealand National Eye Centre, Auckland, Auckland, New Zealand; 4Research, Opthalmic Trials Australia, Brisbane, Queensland, Australia; 5Research, Azura Ophthalmics Limited, Tel Aviv, Israel;

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 cut offs

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

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 the adverse ocular effects, including blepharitis, corneal defects, contact lens discomfort and dry eye disease; 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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