Abstract
Purpose :
Meibomian gland dysfunction (MGD) is characterized by terminal duct obstruction and/or changes to meibomian gland (MG) secretion. Pharmacological therapies for terminal duct obstruction in MGD are lacking. This clinical trial evaluated the safety and efficacy of AZR ointment/semi-solid drug, a novel MGD treatment.
Methods :
A pre-planned interim-analysis (IA) of data from this multicenter, double-masked, vehicle-controlled, randomized, parallel group clinical trial (clinicaltrials.gov NCT03652051) was undertaken. Key participant inclusion criteria were an Ocular Surface Disease Index (OSDI) score of 13 to 33 and Meibomian Gland Score (MGS) <12. The IA involved participant groups that received sequentially higher concentrations of AZR (0.1% (n = 9), 0.5% (n = 7), or 1.0% (n = 7)) compared to vehicle (n = 9), in a 4:1 ratio within each group, over 3 months. Pre-specified efficacy measures included OSDI score, MGS and Meibomian Gland Yielding Liquid Secretion (MGYLS). Safety was evaluated using the adverse event (AE) rate.
Results :
The mean (SD) age of each study group was similar (overall: 44.6 (19.7) years, n=33), and 52% of participants were female. At Month 3, a minimal clinically important improvement in dry eye symptoms (change in OSDI score ≥4.5 units) was observed in 22.2% (Vehicle), 22.2% (AZR 0.1%), 57.1% (AZR 0.5%) and 85.7% (AZR 1.0%) of participants. The difference between Vehicle and AZR 1.0% was significant (p=0.03). Least square mean change from baseline (higher scores indicate improvement) for MGS at Month 3 were: 4.5 ± 2.0 (Vehicle), 1.2 ± 2.0 (AZR 0.1%), 4.9 ± 2.1 (AZR 0.5%), and 12.2 ± 2.4 (AZR 1.0%). The difference between Vehicle and AZR 1.0% was significant (p=0.03). Results for MGLYS mirrored MGS. The percentage of participants with at least one ocular treatment-emergent AE was 44% (Vehicle), 44% (AZR 0.1%), 71% (AZR 0.5%), and 86% (AZR 1.0%). AEs were transient and did not impact willingness to continue study participation.
Conclusions :
Clinically meaningful improvements in signs and symptoms were observed in individuals with MGD with AZR, with an acceptable safety profile. AZR-MD-001 has potential to be the first effective pharmacotherapy specifically for MGD.
This is a 2021 ARVO Annual Meeting abstract.