AZR-MD-001 Efficacy in Resolving the Signs and Associated Symptoms of Contact Lens Discomfort in a Phase 2 Trial

Abstract

Purpose : This study was designed to investigate whether treating the underlying cause of meibomian gland dysfunction (MGD) with AZR MD 001 (AZR) can open meibomian glands and improve meibum quality in patients with concomitant contact lens discomfort (CLD) and MGD, and subsequently whether it can improve symptoms of CLD in patients who continue to challenge their ocular surface.

Methods : This Phase 2 prospective, multi-center, randomized, double-masked, vehicle-controlled, parallel-design trial included 67 participants aged 18 and older with CLD (Contact Lens Dry Eye Questionnaire-8 >12) and evidence of meibomian gland obstruction (Meibomian Gland Secretion Score <12) who were randomized (1:1) to AZR 0.5% (n=34) or vehicle (n=33) (NCT05548491). Per the study inclusion criteria, none of the patients entering the study could wear their lenses as desired. Participants applied therapy to the lower lid margin twice weekly at bedtime. Response rates were assessed at Day 14, Month 1, Month 1.5, and Month 3 compared to the vehicle using predefined responder criteria, based on literature thresholds. For signs: Meibomian Glands Yielding Liquid Secretion (MGYLS) change from baseline ≥5 and Meibomian Gland Secretion (MGS) score >12. Symptom response rates were assessed as the percentage of participants who reported the ability to comfortably wear CLs for as long as desired.

Results : At Month 3, AZR showed a statistically significant higher percentage of patients with a clinically meaningful improvement of ≥5 more MGYLS compared with vehicle (58.2% vs vehicle 6.1%, p<0.0001). Significantly more patients treated with AZR demonstrated normal meibum secretion quality (MGS >12) as early as Day 14 (52.9% vs vehicle 6.1%, p<0.0001) which continued through Month 3 (97.1% vs vehicle 33.6%, p<0.0001). By month 3, significantly more patients treated with AZR were able to wear their CLs comfortably for as long as desired (42.5% vs vehicle 6.2%, p=0.0015). All ophthalmic treatment-emergent adverse events (TEAEs) (47/47) in the 0.5% group were mild to moderate. There were no discontinuations due to a TEAE.

Conclusions : AZR MD 001 significantly improved the proportion of subjects with open glands and normal meibum secretion quality resulting in more patients who could wear their CLs comfortably for as long as they desired compared to vehicle.

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