Azura Ophthalmics Begins Phase 3 Trial for AZR-MD-001 in MGD Patients

Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company based in TEL AVIV, Israel, has initiated the ASTRO study. This Phase 3 clinical trial is designed to evaluate the efficacy and safety of the company's lead investigational drug candidate, AZR-MD-001, for the treatment of Meibomian Gland Dysfunction (MGD). This announcement marks a significant step in Azura's efforts to develop new therapeutic treatments for ocular surface diseases.

MGD is a chronic and progressive condition that impacts approximately 100 million people in the United States. It is characterized by blockages in the meibomian glands, which are responsible for secreting meibum—a crucial component of the eye's tear film. These blockages result in poor quality and reduced quantity of meibum, leading to various symptoms, including ocular surface dryness, pain, irritation, and decreased vision quality. MGD is also a primary cause of Dry Eye Disease (DED) and contributes to Contact Lens Discomfort (CLD).

Dr. Francis Mah, Director of Cornea and External Disease at Scripps Clinic Medical Group, emphasized the promise of AZR-MD-001, citing its demonstrated efficacy in previous studies. The Phase 3 ASTRO study aims to provide further insights into the drug's potential as a foundational treatment for MGD, specifically its ability to restore meibomian gland function.

The ASTRO trial is a multicenter, double-masked, vehicle-controlled, randomized study. It will assess the efficacy, safety, and tolerability of AZR-MD-001 ophthalmic ointment compared to a vehicle in patients with abnormal meibomian gland function and DED symptoms. Around 500 patients will participate, applying the ointment twice weekly for up to 12 months. The study will involve several follow-up visits—on day 14, month 1.5, month 3, month 4.5, month 6, month 9, and month 12. Participants will exit the study approximately 13 months after their baseline visit, and any ongoing adverse effects will be monitored for an additional 30 days.

The primary endpoints of the study include changes from baseline to month 3 in both meibomian gland function and Ocular Surface Disease Index (OSDI©) scores. Secondary endpoints involve assessing changes in the Standard Patient Evaluation of Eye Dryness (SPEED) score. The study also aims to evaluate the drug's impact on additional sign and symptom measures and its overall safety and tolerability over the 12-month period.

Marc Gleeson, Chief Executive Officer of Azura, expressed optimism about the study's potential to demonstrate the effectiveness and safety of AZR-MD-001. He highlighted the company's commitment to alleviating the burden of MGD and associated ocular surface conditions for patients.

AZR-MD-001 employs selenium sulfide (SeS2) in an ophthalmic ointment that is applied to the meibomian glands in the lower eyelid. The mechanism of action includes breaking down abnormal keratin proteins to alleviate glandular blockage, reducing keratin production to prevent future blockages, and enhancing the quality and quantity of meibum. The drug is currently under investigation for its safety, efficacy, and tolerability in patients with MGD and DED symptoms, though it has not yet received approval from the U.S. FDA.

Azura Ophthalmics is leveraging its expertise in ocular surface diseases and drug development to create a new class of Ophthalmic Keratolytics. Their approach integrates ophthalmologic and dermatologic strategies to address the root causes of various underserved ocular conditions. The company's pipeline consists of first-in-class ophthalmic therapeutics aimed at addressing significant unmet medical needs.