Azura Ophthalmics presents positive results from Phase 2b clinical trial of AZR-MD-001

AZR-MD-001, harnesses the power of selenium sulfide (SeS2) in an ophthalmic ointment preparation applied directly to the meibomian glands in the lower eyelid.

Azura Ophthalmics Ltd. this week announced that positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in meibomian gland dysfunction were presented for the first time at Ophthalmology Innovation Summit XII (OIS) on December 3 San Diego, California.

According to a news release, AZR-MD-001, harnesses the power of selenium sulfide (SeS2) in an ophthalmic ointment preparation applied directly to the meibomian glands in the lower eyelid. AZR-MD-001 is thought to have a multi-modal mechanism of action that treats the pathophysiology of meibomian gland dysfunction (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-center clinical trial of AZR-MD-001 0.5% in 2023.

Marc Gleeson, CEO of Azura, noted in a press release that positive Phase 2b data signal a key step forward in the company’s advancement of AZR-MD-001 for the development of a therapeutic treating the root cause of MGD and resulting ocular surface symptoms.

“With MGD impacting an estimated 100 million Americans,1,2AZR-MD-001 has the potential to bring relief to a large patient population in need of innovative treatment options,” he said in a news release. “It was a pleasure to share our exciting Phase 2b results at OIS XII, and we look forward to advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.”

The results from Azura’s Phase 2b study of AZR-MD-001 0.5% in MGD were presented during the “Spotlight on Dry Eye” session at OIS XII.

About the Phase 2b 3-month results

According to the company, the Phase 2b trial was a multi-center, 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. The prospectively defined co-primary efficacy endpoints included the number of glands secreting meibum as measured by the Meibomian Glands Yielding Liquid Secretion (MGYLS) score and patient-reported symptoms as measured by the Ocular Surface Disease Index©3 (OSDI©) score.

AZR-MD-001 0.5% achieved statistically significant differences compared to vehicle in both signs and symptoms at month 3:

• 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.

Additional patient-reported outcomes, using well established questionnaires, also demonstrated statistically significant improvements for AZR-MD-001 0.5% from baseline:

• Significant improvements in SPEED (p<0.0001) and Average VAS (visual analogue scale) (p<0.0001).
• Significant improvements in Eye Discomfort (p<0.0001), Eye Dryness (p<0.0001) and Ocular Itch (p<0.0001).

The majority of adverse events (AEs) were mild and transient with no serious treatment-related AEs. The number of subjects with treatment emergent AEs leading to discontinuation was 2.4% for AZR-MD-001 0.5%.