Azura Ophthalmics Ltd. has enrolled the first patient in its phase 3 clinical trial evaluating the safety and efficacy of AZR-MD-001, its investigational candidate for the treatment of meibomian gland dysfunction (MGD).
Let’s begin with this candidate.
As a selenium sulfide ophthalmic ointment, AZR-MD-001 is designed to be applied directly to the surface of the lower eyelid.
Its proposed indications: MGD and vision quality associated with contact lens discomfort (CLD).
And its mechanism of action?
The formulation is intended to target the primary pathophysiology of abnormal keratin production and obstruction, poor meibum quality, and resulting ocular signs and symptoms by potentially:
- Slowing down the rate of keratinocyte proliferation and keratin production (slowing meibomian gland plug formation and obstruction
- Softening keratin aggregates by breaking down disulfide bonds, opening obstructions, and improving meibum quality and flow through the meibomian glands
- Stimulating lipogenesis to increase lipid quantity produced by the meibum glands
- Killing mites and bacteria on eyelash follicles
Interesting … what kind of clinical data is available on it?
Most recently: Positive data from a two-stage, multivehicle phase 2 study (NCT05548491) assessing AZR-MD-001 in patients with CLD demonstrating signs and symptoms of MGD were released in December 2023.
Read our rundown, which includes input from Azura CEO Marc Gleeson in an interview with Glance President Jaclyn Garlich, OD, FAAO.
What about for MGD alone?
There’s also phase 2 data! Reported in August 2023—and published in The Ocular Surface—the randomized, double-masked multicenter study (NCT03652051) assessed AZR-MD-001 (0.5% and 1.0%) vs vehicle in patients with MGD and evaporative dry eye disease (DED).
Those findings: The study met both its primary endpoints (Meibomian Gland Secretion [MGS] Score and Meibomian Glands Yielding Liquid Secretion [MGYLS] at Month 3).
In a nutshell: Treatment with AZR-MD-001 0.5% resulted in more open meibomian glands and greater symptom relief than vehicle (and more so than the 1.0% dosage).
Read the full recap here (including details on associated adverse events).
Gotcha. So about this phase 3 study…
The Assessment of Secretions and Treatment for Restoring Ocular surface health in patients with meibomian gland dysfunction (ASTRO) study (NCT06329791) is a double-masked, vehicle-controlled, randomized, multicenter trial evaluating AZR-MD-001 0.5% in patients with abnormal meibomian gland function and DED-associated symptoms.
- The participants: n = 500 (estimated)
- The dosages: twice weekly (BIW) at night (for up to 12 months)
- Randomization: 1:1 ratio
- Follow-up visits: Day 14 and Months 1.5, 3, 4.5, 6, 9 and 12
- Conclusion timeline: Approximately 13 months following baseline visit
- Note: Any ongoing treatment-emergent adverse events (TEAEs) at Month 12 will be followed for +30 days
What’s being measured?
- Primary endpoints:
- Change from baseline to month 3 in MGYLS (0 to 15 scale)
- Change from baseline to month 3 in total Ocular Surface Disease Index (OSDI) (0 to 100 scale)
- Secondary endpoint:
- Change from baseline to month 3 in Standard Patient Evaluation of Eye Dryness (SPEED) score (0 to 28 scale)
- Also: Secondary objectives involve AZR-MD-001’s:
- Ability to improve additional sign and symptom measures (vs vehicle)
- Safety and tolerability when applied to the lower eyelid BIW through Month 12
Alrighty … now when can we expect data?
While Clinical Trials reports the study is expected to conclude in November 2025, we’ll likely hear about interim data sometime before then… so stay tuned!
And the overall significance?
An FDA approval of AZR-MD-001 would make the ointment the first-in-class ophthalmic keratolytic to treat lid margin disease, starting with MGD.