Industry News
Azura Ophthalmics Reports Positive Phase 2 Results for Novel Ophthalmic Keratolytic
Clinical-stage biopharmaceutical company, Azura Ophthalmics Ltd., has unveiled promising outcomes from its Phase 2 study of AZR-MD-001, a novel Ophthalmic Keratolytic designed for ocular surface diseases, particularly in patients experiencing Contact Lens Discomfort (CLD) and demonstrating signs of Meibomian Gland Dysfunction (MGD).
The Phase 2 trial successfully achieved its primary endpoint by demonstrating a statistically significant improvement in Meibomian Glands Yielding Liquid Secretion (MGYLS), measured by the number of open glands. Additionally, the study met various secondary endpoints, including enhancements in meibum quality (Meibomian Gland Score, MGS), tear stability (tear break-up time, TBUT), ocular surface staining (both fluorescein and lissamine green staining), and contact lens wear time.
AZR-MD-001 exhibited a favorable safety profile, with all observed adverse events being mild to moderate in severity, and none leading to treatment discontinuation. This successful Phase 2 study marks the second instance of AZR-MD-001 demonstrating significant improvements across multiple sign and symptom endpoints in patients with MGD.
Addressing the significance of the findings, Marc Gleeson, Chief Executive Officer of Azura, highlighted the pivotal role of MGD in various ocular surface conditions impacting patients' quality of life and vision, including Contact Lens Discomfort. Gleeson stated, “By opening up blocked glands and improving the quality of the tear film, we believe many of these ocular surface conditions can be resolved.” He emphasized the encouraging aspect that AZR-MD-001 allowed patients who had discontinued contact lens use to comfortably wear their lenses for an additional three hours daily.
MGD, a chronic condition leading to blocked glands in the eyelids, contributes to several ocular surface symptoms such as dryness, pain, irritation, reduced vision quality, and Contact Lens Discomfort. The innovative AZR-MD-001 addresses these issues by targeting the root cause of MGD.
Professor Lyndon Jones from the Centre for Ocular Research & Education in Ontario, Canada, emphasized the significance of addressing the underlying cause of Contact Lens Discomfort. He stated, “With these AZR-MD-001 data, I’m encouraged to see a potential treatment that may address the underlying cause of Contact Lens Discomfort, and I believe my patients would find an extra three hours of comfortable contact lens wear time to be very meaningful.”
Azura Ophthalmics plans to discuss the Phase 2 results with the FDA as they advance into the Phase 3 development program, offering hope for improved solutions in managing MGD-related ocular surface conditions and enhancing the comfort of contact lens wear for patients.
