Azura Ophthalmics Presents Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in MGD

Azura Ophthalmics announced that positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD), were presented for the first time at Ophthalmology Innovation Summit XII (OIS) on Saturday, December 3, 2022 in San Diego, California.

“Azura’s positive phase 2b data signal a key step forward in our advancement of AZR-MD-001 for the development of a therapeutic treating the root cause of MGD and resulting ocular surface symptoms,” Marc Gleeson, Chief Executive Officer of Azura, said in a company news release. “With MGD impacting an estimated 100 million Americans,[1,2 AZR-MD-001 has the potential to bring relief to a large patient population in need of innovative treatment options. 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. The recorded presentation is available for viewing on the News & Events section of Azura’s website.

About the Phase 2b 3-Month Results

The phase 2b trial was a multicenter, 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%.