Results of a phase 2 study show that a selenium sulfide ophthalmic ointment (AZR-MD-001) applied twice weekly to the lower eyelid significantly improves the signs and symptoms of mild-to-moderate meibomian gland disease (MGD) with minimal adverse events.
Study design
This Phase 2 study conducted from February 2021 to August 2022 was a randomized, double-masked, vehicle-controlled, parallel-group, multicenter investigation conducted across 29 sites in Australia, New Zealand, and Canada that investigated the safety and efficacy of selenium sulfide ophthalmic ointment (AZR-MD-001) in patients with signs and symptoms of MGD. Two hundred forty-five patients were randomized to receive AZR-MD-001 0.5%, AZR-MD-001 1.0%, or vehicle applied twice weekly at bedtime to the lower eyelid. Signs and symptoms of MGD were assessed over 3 months using changes from baseline in Meibomian Glands Yielding Liquid Secretion (MGYLS) score, which reflects the number of open meibomian glands, and Ocular Surface Disease Index (OSDI), a measure of patient-reported ocular surface symptoms.
Outcomes
Twice-weekly AZR-MD-001 0.5% treatment resulted in statistically significant improvements in both co-primary efficacy endpoints; MGYLS score increased by an average of 4.2 open glands secreting meibum (vs 2.4 in the vehicle group), and OSDI total score increased by an average of 7.3 (vs 3.8 in the vehicle group). Most treatment-emergent adverse events were mild and transient, with the most common being application-site pain in about 15% of patients.
Limitations
One limitation of this study is that it did not include a comparison to standard at-home, warm-compress therapy, or other topical therapies such as artificial tears. The follow-up duration of only 3 months is also short, especially given the chronic nature of MGD. Exclusion of patients with significant meibomian gland atrophy (>75%) limits the clinical relevance for treating severe MGD.
Clinical significance
Selenium sulfide ophthalmic ointment (AZR-MD-001) is a novel keratolytic and lipogenic agent that improves both the signs and symptoms of MGD and, requiring only twice-weekly dosing, it offers an advantage over standard warm-compress heat therapy.
Financial disclosures: Dr. Neel Pasricha discloses financial relationships with Iota Biosciences, Vanda Pharmaceuticals, and Zeiss (Consultant/Advisor).