Azura Receives FDA Feedback Supporting Planned NDA Submission for AZR-MD-001
Azura Ophthalmics, which is developing a potentially first-in-class ophthalmic keratolytic for meibomian gland dysfunction (MGD), announced that it has received feedback from a pre-new drug application (NDA) meeting with the FDA. The agency confirmed that Azura’s existing clinical development package is sufficient to support the company’s planned NDA submission for AZR-MD-001.
“We are very encouraged by the FDA’s feedback and pleased by their determination that our existing clinical data package satisfies the requirements for a sign and symptom in two adequate and well-controlled confirmatory efficacy studies,” said Marc Gleeson, CEO of Azura Ophthalmics. “We believe AZR-MD-001 has the potential to redefine how patients with meibomian gland dysfunction and dry eye disease are treated by directly targeting gland function with a novel, easy-to-administer, twice-weekly ophthalmic ointment. As a company, we are focused on submitting our NDA package in the second half of 2026.”
During the pre-NDA meeting, the FDA affirmed that results from Azura’s CELESTIAL and ARIES clinical trials satisfy regulatory efficacy requirements for approvability of AZR-MD-001 in treating the signs and symptoms of dry eye disease (DED). Across the two studies, the drug demonstrated:
Statistically significant improvement in Meibomian Glands Yielding Liquid Secretion (MGYLS) in the CELESTIAL study
Symptomatic improvement in Ocular Surface Disease Index (OSDI) in CELESTIAL
Increased comfortable contact lens wear time in the ARIES study
The FDA also indicated that the combined safety data from the CELESTIAL, ARIES, and ASTRO trials will meet the requirements for NDA submission. Additional long-term safety data from the ongoing ASTRO study are expected in Q1 2026 and will further support the application.
According to Azura, to date, more than 500 patients have been treated with AZR-MD-001 in clinical trials. The investigational therapy has been well-tolerated, with a safety profile consistent with chronic ophthalmic use.
AZR-MD-001 is uniquely designed with a triple mechanism of action—keratolytic, keratostatic, and lipogenic—positioning it as a distinct and potentially highly differentiated therapy within the Dry Eye Disease landscape. The ointment is applied directly to the lower eyelid margin twice weekly at bedtime, where it is intended to restore meibomian gland function, improve tear film stability, and reduce symptoms associated with dry eye disease, including contact lens discomfort (CLD).
“We continue to see growing recognition among physicians that AZR-MD-001 addresses meibomian gland obstruction, an important and previously untreated root cause of dry eye disease,” said Francis Mah, MD, Director of Cornea and External Disease and Co-Director of Refractive Surgery at Scripps Clinic Medical Group in La Jolla, California. “A product that can open and restore gland function with a convenient, twice-weekly dose could be practice-changing for millions of patients.”