The investigational drug, AZR-MD-001 0.5%, met its co-primary endpoints of improvements in meibomian glands yielding liquid secretion (MGYL) and Ocular Surface Disease Index (OSDI) in a phase 2b study evaluating 3-month efficacy and safety in patients with meibomian gland dysfunction (MGD), according to a press release from Azura Ophthalmics.
The trial also met additional clinically meaningful endpoints, including improvements in meibum quality, tear stability, and multiple patient-reported outcome measures (SPEED and average VAS).
“At Azura, we are taking a completely new approach to treating MGD which is the root cause of many downstream ocular surface conditions,” said Marc Gleeson, Chief Executive Officer of Azura. “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.”
Most adverse events were mild and transient with no serious treatment-related AEs. Treatment-emergent adverse events related to AZR-MD-001 0.5% led to discontinuation in 2.4% of participants.
Read the full press release here.
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