Abstract
Purpose :
Meibomian gland dysfunction (MGD) disrupts gland function, causing tear film abnormalities and ocular symptoms. AZR-MD-001 (AZR) selenium sulfide topical ointment was investigated as a treatment for MGD. Changes in tear film stability and symptoms of MGD were evaluated.
Methods :
In a Phase 2, 6-month, multicenter, double-masked, vehicle-controlled, parallel-group trial (NCT03652051), 245 adults were randomized to receive treatment (AZR 0.5% [n=82], 1.0% [n=83] or vehicle [n=80]) applied twice weekly to the lower eyelid before bedtime. Eligible participants had a Meibomian Gland Secretion (MGS) score ≤12, Ocular Surface Disease Index (OSDI) score of 13 to 33, and tear breakup time (TBUT)<10 seconds. Tear film stability was assessed by sodium fluorescein TBUT. Eye dryness, discomfort, and itch symptoms were assessed using VAS scales, and the Standard Patient Evaluation of Eye Dryness (SPEED) survey to measure symptoms.
Results :
AZR achieved statistically significant improvements vs vehicle for TBUT at M3 (Mean [SE] AZR 0.5% M3 = 2.21s [0.29], p<0.0001, M6 = 2.26 [0.40], p=0.20; 1.0% M3 = 1.53s [0.33], p=0.0187, M6 = 1.31s [0.40], p=0.63; vehicle M3 = 0.52s [0.29], M6 = 1.56s [0.38]). Dry eye symptoms and eye dryness were both significantly reduced, compared to vehicle, through Month 6 (SPEED AZR 0.5% M3 =-4.29 [0.46], p=0.0178; M6=-4.8 [0.54], p=0.0025; 1.0% M3 =-4.12 [0.45]; p=0.0311; M6 =-4.6 [0.54], p=0.0059; vehicle M3 =-2.8 [0.44], M6 =-2.5 [0.52]; VAS AZR 0.5% M1.5 =-24.4 [2.39], p=0.0105, M6=-32.3 [2.62], p=0.0037; 1.0% M6=-29.9 [2.6], p=0.0242; vehicle M1.5 =-15.7 [2.40], M6=-21.8 [2.53]). Eye discomfort significantly improved from baseline reaching significance compared to vehicle at M6 (VAS 0.5% M6=-24.0 [2.35], CFB p<0.0001, vehicle p=0.0034; 1.0% M6=-22.1 [2.34], CFB p<0.0001, vehicle p=0.0202). Ocular itch significantly improved from baseline reaching significance compared to vehicle for the 0.5% group at M3 and M6 (VAS 0.5% M3=-15.3 [2.47], CFB p<0.0001, p=0.0039; M6=-18.9 [2.20], CFB p<0.0001, vehicle p=0.0007; 1.0% M3=-10.1 [2.28], p=0.1832; M6=-14.0 [2.22], CFB p<0.0001, vehicle p=0.071).
Conclusions :
Biweekly treatment with AZR-MD-001 0.5% significantly improved tear film quality compared to vehicle, which resulted in clinically significant improvements in ocular symptoms through 6 months of treatment.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.