New clinical data presented during the American Academy of Optometry (AAOPT) annual meeting offered an update from Azura Ophthalmics Limited’s phase 2 trial assessing AZR-MD-001 for the treatment of meibomian gland dysfunction (MGD).
Let’s start with a refresher on AZR-MD-001.
AZR-MD-001 is a selenium sulfide ophthalmic ointment designed to be applied directly to the surface of the lower eyelid as a potential treatment for MGD.
Exactly how does it work?
Per Azura, the formulation is intended to target the primary pathophysiology of abnormal keratin production and obstruction, poor meibum quality, and resulting ocular signs and symptoms which might:
- Slow down the rate of keratinocyte proliferation and keratin production (slowing meibomian gland plug formation and obstruction.
- Soften keratin aggregates by breaking down disulfide bonds, opening obstructions, and improving meibum quality and flow through the meibomian glands.
- Stimulate lipogenesis to increase lipid quantity produced by the meibum glands.
- Kill mites and bacteria on eyelash follicles.
Gotcha. Now this study.
The randomized, double-masked, vehicle-controlled, parallel-group, multicenter trial (NCT03652051) enrolled 245 patients (ages 18+) diagnosed with MGD and evaporative dry eye disease (DED).
Conducted at 29 sites across Australia, New Zealand, and Canada, patients were enrolled based on the following criteria at screening and baseline:
- Best-corrected visual acuity (BCVA) of 20/40 or better
- Evidence of meibomian gland obstruction
- Reported dry eye signs and symptoms (with past 3 months)
See here for exclusion criteria.
How about the dosages?
Patients were randomized 1:1 to receive one of two doses of AZR-MD-001 (0.5% [n=82] or 1.0% [n=83]) or vehicle (n=80) in both eyes, applied twice weekly immediately before sleep on the lower eyelids.
To note, all participants were stratified by MGD diagnosis duration (<5 or ≥5 years) and Meibomian Gland Secretion (MGS) score (<6, or ≥6 and ≤ 12) at baseline.
What did previous data find?
Released in August 2023, 3-month data showed AZR-MD-001 0.5% met both primary endpoints, with a significantly greater improvement noted in Meibomian Gland Yielding Liquid Secretion (MGYLS) scores from baseline to Month 3 vs vehicle.
Similarly, the 0.5% dosage resulted in a significantly greater improvement from baseline to Month 3 for the Ocular Surface Disease Index (OSDI) total score when compared to vehicle.
Overall, treatment with AZR-MD-001 0.5% demonstrated an average increase in open glands secreting meibum along with greater symptom relief than vehicle.
See here for our coverage.
Now to this new data … who presented it?
- Lyndon Jones, DipCCLRT; PhD, DSc, FCOptom, FAAO
- Centre for Ocular Research & Education (CORE; Waterloo, Canada))
- Jennifer Craig, PhD FCOptom, FAAO, FBCLA, FCLS
- Ocular Surface Laboratory, University of Auckland (New Zealand)
- Mark Hinds, BOptom
- Ophthalmic Trials Australia (Brisbane, Australia)
- Yair Alster, PhD Azura Ophthalmics (Tel Aviv, Israel)
- Charles Bosworth, PhD
- Azura Ophthalmics (Tel Aviv, Israel)
- Alison Ng, PhD, BSc(Hons), MCOptom, FAAO
- CORE (Waterloo, Canada)
And the findings?
At Month 3, investigators noted that AZR-MD-001 demonstrated a higher percentage of patients with a clinically meaningful improvement of ≥5 more glands yielding meibum compared to vehicle:
- MGYLS: 60%, p<0.0001 for AZR MD 001 0.5%
- MGLYS: 43%, p=0.0218 for AZR MD 001 1.0%
- MGLYS: 22% for vehicle
Go on …
Additionally, a significantly larger number of patients who received AZR-MD-001 of either dosage achieved normal meibum (MGS > 12) as early as 14 days, according to the data readout:
- AZR-MD-001 0.5%
- 20%, p=0.0380
- AZR-MD-001 1.0%
- 19%, p=0.0949
- Vehicle
- 7.6%
And by Month 6?
At that point, patients continued to present with normal meibum:
- AZR-MD-001 0.5%
- 74%, p=0.0017
- AZR-MD-001 1.0%
- 63%, p=0.1273
- Vehicle
- 48%
How many were asymptomatic?
By Month 6, significantly more AZR-MD-001-treated patients (of both dosages) were asymptomatic for disease (OSDI <13):
- AZR-MD-001 0.5%
- 48%, p=0.0333
- AZR-MD-001 1.0%;
- 50%, p=0.0205
- Vehicle
- 30%
So what did the presenters conclude?
They concluded that a statistically significant proportion of AZR-MD-001-treated patients exhibited a clinically meaningful response, “normalization of their meibomian gland function and the achievement of asymptomatic status for disease.”
These poster findings were presented at the American Academy of Optometry (AAOPT) annual meeting in New Orleans, Louisiana, October 11-14, 2023.