The FDA has given Azura Ophthalmics Ltd. positive feedback following a pre-new drug application (NDA) meeting regarding its selenium sulfide ointment for meibomian gland dysfunction (MGD).
It’s been a minute since we’ve heard about Azura …
Indeed, it has. A quick refresh for you:
Founded in 2014 and headquartered in Tel Aviv, Israel, the clinical-stage biopharmaceutical company is developing a new therapeutic class of ophthalmic keratolytics to treat underserved ophthalmic conditions.
Why utilize keratolytics?
What they are: Agents capable of breaking apart disulfide bonds, which bind keratin together into aggregates and treat dermatologic conditions (acne).
- More importantly, though: They’ve also reportedly been used to “enhance penetration of other topical medications into deeper tissue layers that are more distal to the site of application.”
In Azura’s case: The company noted that keratolytics can combine with known treatments—both ophthalmologic and dermatologic—to create first-in-class new chemical entities (NCEs) that address the full spectrum of lid margin and ocular surface diseases (OSDs).
And what conditions do these include?
Aside from MGD, Azura is targeting:
- Vision quality associated with contact lens discomfort (CLD)
- Posterior blepharitis
- Demodex NCE
- Ocular graft-versus-host-disease (GvHD)
- Pediatric blepharokeratoconjunctivitis
Now to this selenium sulfide ointment.
Dubbed AZR-MD-001, the ointment is one such keratolytic agent Azura’s developing that’s designed for direct topical application to the surface of the lower eyelid.
- Its investigational indications: MGD and CLD.
- And its dosing schedule: Twice weekly at bedtime.
Back up and explain selenium sulfide.
Operating as a cytostatic agent, this formulation is known to slow the rate of skin cell turnover in the epidermis and follicular epithelium (leading to reduced flaking on the scalp [dandruff] or skin), as well as containing antifungal / antibacterial properties.
- As a treatment: It’s typically available as an over-the-counter (OTC) topical treatment or prescription-based medication (such as in a shampoo), depending on the dose strength.
Noted. Now, exactly how does Azura’s ointment address MGD?
AZR-MD-001 targets MGD by targeting a major cause of obstruction: abnormal keratinization (buildup) at the lid margin and meibomian orifices (which lead to poor meibum quality).
Specifically, the topical ointment is intended to:
- Slow the rate of keratinocyte proliferation and keratin production (thereby reducing 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 meibomian glands.
- Kill mites and bacteria on eyelash follicles.
So … in a nutshell?
AZR-MD-001 is designed to restore meibomian gland function, improve tear stability, and reduce symptoms associated with DED (including CLD).
- All in all, the intended result is to alleviate the signs and symptoms of MGD.
Next up: What's the clinical data on it thus far?
We’ll refer you to our prior reporting on phase 2 findings from both its MGD and CLD indications.
Focusing on MGD: Azura reported results from a randomized, double-masked, multicenter study in August 2023 that evaluated the candidate in two concentrations (0.5% and 1.0%) versus a vehicle.
- The data: 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) among patients.
And for CLD: Check out this rundown on positive data from the ARIES trial (NCT05548491), a two-stage, multivehicle phase 2 study reported in December 2023.
How about phase 3 data?
Based on our most recent coverage: Azura announced the first patient enrollment in June 2024 for its phase 3 ASTRO trial (NCT06329791) evaluating patients with abnormal meibomian gland function and DED-associated symptoms.
But per the company’s latest announcement, it appears positive data is available from ASTRO, as well as a second phase 3 study: CELESTIAL (NCT03652051).
Can we get a look at that phase 3 data?
Those findings (as well as the ARIES trial’s data) were actually a focal point of Azura’s pre-NDA meeting with the FDA.
Specifically: The federal agency confirmed that both the CELESTIAL and ARIES study data “fulfill the regulatory efficacy requirements for approvability of AZR-MD-001” for its treatment of DED signs and symptoms.
- According to Azura: The findings from both studies “demonstrate statistically significant improvement” in Meibomian Glands Yielding Liquid Secretion (MGYLS) as well as:
- Symptomatic benefit in ocular surface disease index (OSDI) in CELESTIAL
- Increased comfortable contact lens wear time in ARIES
And regarding this NDA submission?
The FDA reportedly indicated that the safety database of all three studies—ARIES, ASTRO, and CELESTIAL—is “sufficient for submission.”
Additionally: New long-term (12-month) safety data from the ongoing ASTRO study is expected to be released in Q1 2026, “further supporting the application,” Azura stated.
So what’s the timeframe we’re looking at?
- First: Phase 3 ASTRO data reported in Q1 2026.
- Then: An NDA submission in H2 2026.
… and now we wait!