Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced positive topline efficacy and safety results from a phase 2 study of AZR-MD-001 in patients with Contact Lens Discomfort (CLD) who could not comfortably wear their lenses as desired and who demonstrated signs of Meibomian Gland Dysfunction (MGD).
The trial met its primary endpoint of showing a statistically significant improvement in Meibomian Glands Yielding Liquid Secretion (MGYLS; number of open glands).
The study also met additional secondary and clinically meaningful endpoints, including significant improvements in meibum quality (measured by Meibomian Gland Score, MGS); tear stability (measured by tear break up time, TBUT); ocular surface staining (measured by both fluorescein and lissamine green staining); and contact lens wear time. AZR-MD-001 was safe and well tolerated. All observed adverse events were mild to moderate in severity and none resulted in treatment discontinuation.
This is the second positive phase 2 study of AZR-MD-001 to demonstrate statistically significant improvements across multiple sign and symptom endpoints in patients with MGD.
“MGD is the root cause of many downstream ocular surface conditions that impact quality of life and vision for patients, including Contact Lens Discomfort. By opening up blocked glands and improving the quality of the tear film, we believe many of these ocular surface conditions can be resolved,” said Marc Gleeson, CEO of Azura. “In addition to meeting its primary MGYLS endpoint, we are especially encouraged that AZD-MD-001 allowed patients who had given up using contacts to wear their contacts again – safely and comfortably – for an additional three hours every day over their normal wear time. We now have two studies showing AZR-MD-001 can improve the signs and symptoms of MGD and we look forward to discussing these results with the FDA as we advance our phase 3 development program.”
MGD is a chronic condition that causes the glands in the eyelids to become blocked, impacting the quality and quantity of meibum secretions in the upper and lower eyelids. This leads to several downstream ocular surface symptoms including dryness, pain, irritation, reduced quality of vision, and Contact Lens Discomfort. Many patients who have signs of ocular surface disease including MGD and who would like to wear contact lenses find they cannot wear them for as long as desired and may stop using contact lenses if wearing them becomes too bothersome or uncomfortable.
“MGD is one of the causes of Contact Lens Discomfort, and many patients give up on wearing contact lenses altogether due to the irritation they experience. Innovation in contact lens design and materials intended to offer a more comfortable patient experience has stalled, with reports of discomfort at the end of the day being similar for the past 20 years. This leaves patients frustrated and seeking alternative vision correction options,” said Lyndon Jones, PhD, director and professor at the Centre for Ocular Research & Education in Ontario, Canada. “With these AZR-MD-001 data, I’m encouraged to see a potential treatment that may address the underlying cause of Contact Lens Discomfort, and I believe my patients would find an extra three hours of comfortable contact lens wear time to be very meaningful.”
About the Contact Lens Discomfort Study
(ClinicalTrials.gov ID NCT05548491)
The phase 2 trial was a multi-center, vehicle-controlled study that evaluated the safety and efficacy of AZR-MD-001 0.5% compared to its vehicle in 67 patients diagnosed with Contact Lens Discomfort who could not comfortably wear their contact lenses as desired and who had signs of MGD. Patients self-administered AZR-MD-001 or its vehicle to the lower eyelid at bedtime twice weekly for 3 months.
The prospectively defined primary efficacy endpoint was the number of open glands as measured by the MGYLS score.
Secondary endpoints included comfortable contact lens wear time reported in minutes, corneal and conjunctival staining using the Oxford scale, and responder analyses based upon published thresholds for MGYLS and MGS.
The trial was supported by a grant from CUREator, a biotechnology incubator run by Brandon BioCatalyst to support and accelerate the development of Australian biomedical research and innovations.AZR-MD-001 0.5% achieved statistically significant differences compared to vehicle in both signs and symptoms at month 3:
- Primary endpoint:
- Significant improvements in MGYLS score, with patients experiencing significantly more open glands on AZR-MD-001 than vehicle (5.0 glands vs 1.6 glands, p<0.0001).
- Secondary endpoints:
- Significantly more patients treated with AZR-MD-001 had at least 5 more glands opened, as measured by MGYLS responder rate, compared to vehicle (58.2% vs 6.1%, p< 0001).
- Significantly more patients treated with AZR-MD-001 had their meibum quality return to normal levels, as measured by MGS responder rate, compared to vehicle (97.1% vs. 33.6%, p<0.0001).
- Comfortable contact lens wear time increased by 192 minutes for AZR-MD-001 treated patients compared to 0.65 minutes for vehicle treated patients (p<0.0001).
- AZR-MD-001 significantly decreased fluorescein and lissamine green ocular surface
staining:- AZR-MD-001 was associated with a significant shift toward lower fluorescein staining scores with 67.1% of patients achieving a score of 0 compared to 15.2% of patients treated with vehicle (p=0.0001).
- AZR-MD-001 was associated with a significant shift toward lower nasal lissamine green staining scores with 32.4% of patients achieving a score of 0 compared to 18.1% of patients treated with vehicle (p=0.0038).
- AZR-MD-001 was associated with a significant shift toward lower temporal lissamine green staining scores with 35.5% of patients achieving a score of 0 compared to 12.1% of patients treated with vehicle (p=0.0205).
All Treatment-Emergent Adverse Events (TEAEs) were mild to moderate with no serious treatment-related AEs. No patients discontinued the study due to adverse events.