Azura Ophthalmics Ltd. has received positive feedback from a pre-new drug application (NDA) meeting with the US Food and Drug Administration (FDA) confirming that the company’s existing clinical development program for AZR-MD-001, an investigational ophthalmic keratolytic targeting meibomian gland dysfunction, is sufficient to support its planned NDA submission, according to a press release.

Specifically, the FDA confirmed the CELESTIAL and ARIES study data fulfill the regulatory efficacy requirements. The results from these 2 studies demonstrate statistically significant improvements in Ocular Surface Disease Index in CELESTIAL and in increased comfortable contact lens wear time in ARIES, according to the press release. 

The FDA indicates that the safety database across CELESTIAL, ARIES, as well as ASTRO, the company's phase 3, multicenter, vehicle-controlled, randomized study to evaluate the efficacy, safety, and tolerability of AZR-MD-001 in patients with abnormal meibomian gland function and associated symptoms of DED, is sufficient for submission, with long-term safety data from the ongoing ASTRO study expected to be shared in Q1 2026, further supporting the application, says the company in the press release. 

According to Azura Ophthalmics, AZR-MD-001 is administered directly to the lower eyelid margin twice weekly at bedtime, and is designed to restore meibomian gland function, improve tear stability, and reduce symptoms associated with DED, including contact lens discomfort. OM