AZR-MD-001 Opens Meibomian Glands, Improves Meibum and Tear Quality Resulting in Increased Wear Time and Desired Lens Use in Patients With CLD

Abstract

Purpose : Contact lens discomfort (CLD) is a common problem for practitioners and wearers. Individuals with CLD experience episodic or persistent ocular discomfort symptoms related to lens wear, including visual disturbances, decreased wear time, or discontinuation overall. AZR-MD-001 (AZR) is an ophthalmic keratolytic, keratostatic, and lipogenic ointment containing selenium sulfide, developed to improve signs and symptoms of MGD. This study evaluated if biweekly AZR can open meibomian glands and improve comfortable wear time, allowing patients with CLD who continue to challenge their ocular surface, tear film, and meibomian glands with contact lens use, to wear their contact lenses as desired.

Methods : Adults with CLD and evidence of meibomian gland obstruction (n=67) were randomized (1:1) to AZR 0.5% (n=34) or vehicle (n=33) applied twice weekly at bedtime for 3 months in a Phase 2, multi-center, single-masked parallel-group study (NCT05548491). Key efficacy endpoints evaluated were the change from baseline (CFB) at month 3 compared to vehicle in meibomian gland secretion score (MGS), Tear film stability (TBUT) post lens removal, and total and comfortable wear time.

Results : At month 3, AZR 0.5% significantly improved signs (MGS; TBUT) and lens wear time vs vehicle. Mean [SE] CFB in MGS was 13.8 [0.67] vs vehicle 3.8 [0.68], p<0.0001; TBUT was +3.31 s [0.70] vs vehicle 0.65 s [0.72], p<0.0001; and total comfortable wear time was +192 min [38.07] vs vehicle +2.9 min [38.01], p<0.0001. Significantly more patients, who were unable to comfortably wear contact lenses as desired at baseline, were able to wear them as long as desired by month 3 (42.5% vs vehicle 6.2%, p=0.0015). Improvements over vehicle were first seen on Day 14 in MGS (Mean [SE] CFB 3.2 [0.97] vs vehicle 0.8 [0.91], p<0.0007) and at Month 1 for comfortable wear time +41.6 minutes [24.04] vs vehicle -14.2 minutes [24.04], p=0.0111. All treatment-emergent adverse events (TEAEs) (47/47, 100%) in the 0.5% group were mild to moderate. There were no discontinuations due to a TEAE.

Conclusions : AZR-MD-001 significantly improved the meibum and tear film quality, resulting in improved wear time in patients with CLD compared to vehicle starting as early as 8 doses of treatment. AZR demonstrated efficacy, safety, and tolerability, with no major adverse events observed.

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