A 0.5% selenium sulfide ointment improves Meibomian Glands Yielding Liquid Secretion (MGYLS) score and ocular surface symptoms in individuals with meibomian gland dysfunction (MGD) without severe ophthalmic adverse events, according to a study published in The Ocular Surface.
Researchers enrolled 245 patients with MGD (66.5% women; mean age, 53.2 years) in a phase 2, multi-center, double-masked, parallel group study to assess the drug’s efficacy. Among individuals who completed the trial (n=208), study participants underwent random assignment to twice-weekly treatment with a 0.5% or 1.0% concentration of the selenium sulfide ointment (n=65 and n=67, respectively) or vehicle (n=76). The team evaluated MGYLS scores, Ocular Surface Disease Index (OSDI), Standard Patient Evaluation of Eye Dryness (SPEED), tear breakup time (TBUT), and corneal and conjunctival staining at baseline, 2 weeks, 1.5 months, and 3 months.
The 0.5% selenium sulfide ointment significantly increased MGYLS score at 3 months compared with vehicle treatment (difference, 4.2 vs 2.4; P <.001) and lowered OSDI score (difference, 7.3 vs 3.8), according to the report.
Only 3 serious adverse events were reported with the selenium sulfide treatment and were unrelated to the study drug. The most common treatment-related adverse events with the 0.5% concentration included application site pain (17.1%), increased lacrimation (11.0%), superficial punctate keratitis (9.8%), and corneal staining (6.1%).
“MGD is a chronic, debilitating, and progressive abnormality of the meibomian glands, which has significant downstream consequences if not managed effectively,” according to the study authors. “Combined with the favorable safety and tolerability profile, the results from this Phase 2 study suggest that this novel therapy represents a major advance in the treatment of this common and debilitation condition.”
The inclusion of individuals with meibomian gland loss not exceeding 75% and a short study duration exploring the efficacy of the selenium sulfide ointment are acknowledged limitations to the research.
Disclosure: This research was supported by Azura Ophthalmics. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Watson SL, Jones LW, Stapleton F, et al. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: a vehicle-controlled, randomized clinical trial. Ocul Surf. Published online July 20, 2023. doi:10.1016/j.jtos.2023.07.002