Azura Ophthalmics Ltd. has announced topline results from a phase 2 program evaluating the company’s investigational therapy for the treatment of Meibomian gland dysfunction (MGD). AZR-MD-001 met its primary endpoints showing improvements in signs and symptoms of MGD, reaching statistical significance compared to control. Full data will be presented at upcoming scientific meetings.
Meibomian gland dysfunction is a chronic and progressive condition where the glands that line the eyelids become blocked, preventing them from secreting enough oil into the tear film needed to properly lubricate the eye. MGD represents one of the largest and most underserved segments in ophthalmology but current treatment options are limited and do not address the root cause of the disease.
“We are thrilled by the positive results showing a statistically significant and clinically meaningful improvement in the signs and symptoms of Meibomian gland dysfunction, which validates our multi-mechanism of action and suggests that AZR-MD-001 has the potential to be a first-in-class treatment option for patients with Meibomian gland dysfunction,” said Marc Gleeson, CEO of Azura. “The study findings also provide insight into the target populations, appropriate dosing and endpoints for our phase 3 program.”
Research shows that MGD is the main cause of Dry Eye Disease (DED). Current treatment options for DED are primarily focused on treating inflammation, which only accounts for a minority of the DED population. Azura’s lead compound, AZR-MD-001, is designed to restore Meibomian gland function by addressing the abnormal hyperkeratinization that blocks the glands, alters the quality of the oil and prevents the secretion of lipids into the tears. There are currently no approved medicines for the treatment of MGD.
“Though there are approved treatments for Dry Eye Disease, they are only appropriate for the patients where inflammation is the cause of the disease,” said Edward Holland, M.D., Director, Cornea Services/Professor of Clinical Ophthalmology, Cincinnati Eye Institute/University of Cincinnati. “Research shows that 86% of people with Dry Eye Disease exhibit signs of Meibomian gland dysfunction1. By addressing the underlying cause of Meibomian gland dysfunction that leads to Dry Eye, Azura is taking an entirely different approach to the disease that has the potential to benefit a much broader population of patients.”
About the Phase 2 Program
The program was a multi-center, double-masked, vehicle-controlled integrated analyses of four phase 2 studies that evaluated the safety and efficacy of AZR-MD-001 (0.1%, 0.5% and 1.0%) in 95 patients with MGD. Patients were dosed twice weekly at night time. Primary endpoints included patient-reported symptoms as measured by the Ocular Surface Disease Index© (OSDI) score, the quality of fluid secretion as measured by the Meibomian Gland Score (MGS) and the number of glands secreting meibum as measured by the Meibomian Glands Yielding Liquid Secretion (MGYLS) score.
There was a statistically significant and clinically meaningful reduction of symptoms as measured by a reduction in OSDI score in the two highest doses tested (0.5% and 1.0%) compared to baseline and control. Similar trends were observed in the secondary endpoint of patient-reported symptoms as measured by the Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire. Results demonstrated a statistically significant difference from baseline and control in the 1.0% dose group (p<0.05) and a statistically significant change from baseline in the 0.5% dose group and compared to control. AZR-MD-001 was well tolerated with no serious ocular treatment emergent adverse events (TEAEs). The most common TEAEs were application site irritation, stinging upon application and watery eyes, which only occurred in patients in the 1.0% dose group.
Full news release: www.businesswire.com/news/home/20210303005272/en/Azura-Ophthalmics-Announces-Positive-Topline-Results-From-Phase-2-Program-of-the-Company%E2%80%99s-Investigational-Treatment-for-Meibomian-Gland-Dysfunction
Source: Azura Ophthalmics