Clinical-stage biopharmaceutical company Azura Ophthalmics, which operates out of Melbourne and Tel Aviv, has reported positive three-month results for its lead drug candidate AZR-MD-001 for meibomian gland dysfunction (MGD).
The Israeli-headquartered company with an Australian CEO, Mr Marc Gleeson, announced that efficacy and safety results from its Phase 2b study met its co-primary endpoints of improvements in meibomian glands yielding liquid secretion (MGYLS; number of open glands) and ocular surface disease index (OSDI; improved symptoms).
The trial also met additional clinically meaningful endpoints, including improvements in meibum quality (measured by MGS), improvements in tear stability (measured by tear break up time) and improvements across multiple patient-reported outcome measures (SPEED and average VAS). AZR-MD-001 was safe and well tolerated in this study.
“At Azura, we are taking a completely new approach to treating MGD which is the root cause of many downstream ocular surface conditions,” Gleeson said.
“These data clearly demonstrate consistency in efficacy across multiple sign and symptom endpoints. With as little as four applications of AZR-MD-001, improvement in glandular function was observed and continued to improve over three months. We are thrilled to build upon these positive results by advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.”
According to the company, MGD is a chronic condition characterised by abnormal keratin production which leads to blocked glands and impacts the quality and quantity of meibum secretions in the upper and lower eyelids. It leads to inflammatory ocular surface conditions, ocular surface dryness, pain, irritation, and reduced quality of vision.
“From a clinical perspective, it’s incredibly encouraging to see that AZR-MD-001 0.5% achieved improvements in both the signs and symptoms,” said Dr Lisa Nijm, founder & medical director of Warrenville EyeCare & LASIK in the US.
“These positive data offer the opportunity for us as physicians to address MGD in a completely new way and bring relief to countless patients who are burdened by it and associated ocular surface conditions. I look forward to collaborating with the Azura team and my fellow scientific advisory board members to advance AZR-MD-001.”
Phase 2b three-month results
The Phase 2b trial was a multi-centre, double-masked, vehicle-controlled, parallel group study that evaluated the safety and efficacy of AZR-MD-001 in 245 patients with MGD.
Patients administered AZR-MD-001 twice weekly to the lower eyelid at bedtime.
AZR-MD-001 0.5% achieved statistically significant differences compared to vehicle in both signs and symptoms at month three:
- Co-primary
– Significant improvements in MGYLS score, with patients experiencing an average increase of 1.8 more open glands secreting meibum from baseline (p = 0.0004).
– Significant improvements in OSDI score, with patients reporting an average improvement of 3.5 from baseline (p = 0.0438).
- Key Secondary
– 46.9% of patients became asymptomatic as measured by Total OSDI responder rate.
– 45.7% of patients had at least 5 more glands opened from baseline of 1.7, as measured by MGYLS responder rate.
– 68.7% of patients had their meibum quality return to normal levels, as measured by MGS responder rate.
Azura reported the majority of adverse events (AEs) were mild and transient with none of them serious treatment-related AEs. The number of people with treatment emergent AEs leading to discontinuation was 2.4%.
AZR-MD-001 – explained
Azura’s lead clinical-stage drug candidate, AZR-MD-001, harnesses the power of selenium sulfide (SeS2) in an easy-to-use ophthalmic ointment preparation applied directly to the meibomian glands in the lower eyelid.
The therapy is thought to have a multi-modal mechanism of action that treats the pathophysiology of MGD along with the resulting ocular surface symptoms. It breaks down the bonds between abnormal keratin proteins to soften the blockage, slows down the production of keratin to prevent future blockages and increases the quality and quantity of meibum produced by the meibomian glands.
AZR-MD-001 is currently being studied to evaluate the safety, efficacy, and tolerability of the study drug in patients with MGD. Azura expects to initiate a second pivotal multi-centre clinical trial of AZR-MD-001 0.5% in 2023.
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