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Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction over six months of treatment: A Phase 2, vehicle-controlled, randomized extension trial.

Laura E. Downie,Jennifer P. Craig,Fiona Stapleton,Jacqueline Tan,Lyndon Jones,Alison Ng,Mark Hinds,Charles Bosworth,Y. Alster

Published 2024 in The ocular surface

ABSTRACT

PURPOSE To determine the efficacy and safety of AZR-MD-001 (0.5% and 1.0%) ophthalmic ointment, relative to vehicle, over 3-6 months of treatment, in participants with meibomian gland dysfunction (MGD). METHODS This was a Phase 2, randomized, vehicle-controlled, multicenter extension clinical trial. Eligible participants were adults with MGD (meibomian gland secretion score (MGS) ≤12 out of 15 glands) who discontinued all other dry eye or MGD treatments. Participants were randomized 1:1:1 to apply AZR-MD-001 1.0%, 0.5%, or vehicle to the lower eyelids, twice weekly. Key exploratory endpoints included the least-squared mean difference between groups in the change from baseline in clinical signs (meibomian gland yielding score; MGYLS) and symptoms (Ocular Surface Disease Index; OSDI), at clinic visits at Month 4.5 and 6, and safety measures from 3-6 months. RESULTS Participants (66.5% female) were randomized, at baseline, to AZR-MD-001 0.5% (n=82), 1.0% (n=83), or vehicle (n=80). Statistically significant improvements, compared to vehicle, were observed at Month 6 in MGYLS for both AZR-MD-001 groups (0.5% group: 1.9, 95% CI 0.9 to 2.8, P=0.002; 1.0% group: 1.1, 95% CI 0.2 to 2.1, P=0.026), and in OSDI score for the 0.5% group (-4.5, 95% CI -8.0 to -0.9, P=0.0135). The most common adverse events for AZR-MD-001 were application site pain, superficial punctate keratitis and eye pain; most were mild to moderate in severity, and decreased in incidence over time. CONCLUSIONS AZR-MD-001 (0.5%) was efficacious in treating signs and symptoms of MGD over six months, with a lower observed incidence of new adverse events over time.

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