Safety and Efficacy of Topical AZR-MD-001 for the Treatment of Meibomian Gland Dysfunction in a 6-Month Study

Abstract

Purpose : Meibomian gland dysfunction (MGD) is a chronic, progressive disease characterized by glandular and meibum changes. AZR-MD-001 (AZR) is an ophthalmic keratolytic, keratostatic, and lipogenic selenium sulfide ointment being developed to improve signs and symptoms of MGD.

Methods : Adults with mild to moderate MGD (n=245) were randomized (1:1:1) to AZR 0.5% (n=82) or 1.0% (n=83), or vehicle (n=80) applied by the subjects to the lower eyelid, twice weekly at bedtime for 6 months in a Phase 2, prospective, double-masked trial (NCT03652051). Endpoints evaluated were change from baseline (CFB) at Day 14 (D14), Month 1.5 (M1.5), Month 3 (M3), Month 4.5 (M4.5), and Month 6 (M6) in number of Meibomian Glands Yielding Liquid Secretion (MGYLS), Ocular Surface Disease Index (OSDI) score, and adverse events, compared to vehicle. Month 4.5-6 data are presented for the first time.

Results : AZR 0.5% significantly improved MGD signs at all timepoints (MGYLS mean [SE] M4.5: 4.8 [0.39], p<0.0001; M6: 5.1 [0.34], p=0.0001 vs vehicle M4.5: 2.5 [0.35]; M6: 3.2 [0.34]) and symptoms (OSDI M4.5: -7.9 [1.47], p=0.0500; M6: -9.2 [1.32] p=0.0135 vs vehicle M4.5: -4.0 [1.38], M6: -4.7 [1.26]). AZR 1.0% significantly improved signs at all timepoints (MGYLS mean [SE] M4.5: 4.0 [0.39], p=0.0052; M6: 4.2 [0.35], p=0.0375 vs M4.5: 2.5 [0.35]; M6 3.2 [0.34]) and trended towards improved symptoms (OSDI M4.5: -5.9 [1.43]; M6: -7.9 [1.32] vs vehicle M4.5: -4.0 [1.38], M6: -4.7 [1.26], all p>0.05) The most common drug-related ophthalmic treatment-emergent adverse event (TEAE) was application site pain, occurring in 14 (17.1%), 15 (18.1%), and 0, in participants treated with AZR 0.5%, 1.0%, and vehicle, respectively. The reported application site pain rate reduced to zero with AZR 0.5% from months 4.5 to 6. Most TEAEs (146/152, 96.1%) in the 0.5% group were mild to moderate. There were 5 discontinuations due to a TEAE (AZR 0.5%, 4 [4.9%]; 1.0%, 1 [1.2%]; vehicle, 0).

Conclusions : Six months of biweekly dosing of AZR 0.5% significantly improved signs and symptoms of MGD compared to vehicle. AZR was found to be safe through 6 months of therapy, and tolerability improved with prolonged exposure, in alignment with topical selenium dermatology agents.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.