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Azura has secured funding to support its 2-stage study evaluating the safety, tolerability, and efficacy of AZR-MD-001, its leading candidate, for patients with contact lens discomfort who show signs of meibomian gland dysfunction.
Azura Ophthalmics Ltd. has secured funding to support its 2-stage study evaluating the safety, tolerability, and efficacy of AZR-MD-001, its leading candidate, for patients with contact lens discomfort (CLD) who show meibomian gland dysfunction (MGD).
The company was awarded a grant from CUREator, an Australian-based national biomedical incubator managed by Brandon BioCatalyst, which will provide support for the study of AZR-MD-001, according to a news release.
“We are excited to be awarded this CUREator grant and believe it further serves to validate our differentiated approach of combining ophthalmologic and dermatologic solutions to exploit the properties of keratolytics to treat the root cause of contact lens discomfort and other ocular surface indications,” stated Azura CEO Marc Gleeson, in the release.
AZR-MD-001 ointment (1.0%) is a topical ointment developed to hold properties suited for ophthalmic use—the formulation is applied to the lower lid margin, twice a week, before bedtime.
The candidate was evaluated as a potential treatment for CLD in the ECLIPTIC study (SOVS2019-270), an early pilot study.
“Our pilot study met its primary endpoints by showing statistically significant improvements in multiple measures of meibomian gland secretion and patients’ ability to wear contact lenses as desired,” stated Fiona Stapelton, Scientia Professor, School of Optometry and Vision Science at University of New South Wales Sydney, in the release.
The significant improvements included over baseline in meibum gland secretion score (MGS) and the number of meibomian glands yielding liquid secretion (MGYLS) following treatment of AZR-MD-001 for 3 months (p < 0.0086 and p < 0.0151, respectively), according to the company.
Further analysis from the University of New South Wales (UNSW) found that AZR-MD-001 exhibited a statistically significant improvement over baseline in CLDEQ-8 score at 1 and 4 months (p<0.01) and an improvement in the visual symptoms subscale (frequency and severity of fluctuating vision) of the CLDEQ-8 (p=0.02) for the same periods.1
In an integrated phase 2a analysis across 4 studies conducted by Azura in patients with MGD, findings indicated significant drug effects on the Visual Function subscale of the Ocular Surface Disease Index (OSDI), the company reported.
Additional study data on the candidate includes an observation of significant impact on visual function—which investigators hypothesize to be due to increasing meibum release and/or production. The company also stated:
“Increasing meibum release and/or production strengthens the lipid layer of the tear film which in turn should increase the stability of the precorneal tear film. Since the precorneal tear film is the first major refractive surface in the eye, this should stabilize visual quality and could explain the observed improvements in vision-related patient-reported outcomes.”
AZR-MD-001 is currently undergoing a phase 2 trial to evaluate the safety, efficacy, and tolerability of its use in patients with MGD and evaporative DED. Topline data is expected by Q4 of 2022, according to Azura.