Azura Ophthalmics has 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 and who demonstrated signs of Meibomian Gland Dysfunction (MGD).
The company said the trial met its primary endpoint of showing a statistically significant improvement in Meibomian Glands Yielding Liquid Secretion.
It said the study also met additional secondary and clinically meaningful endpoints, including significant improvements in meibum quality, tear stability, ocular surface 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, said the company.
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 Azura CEO Marc Gleeson.
“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.
“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 Dr Lyndon Jones, the director and Professor at the Centre for Ocular Research and Education in Ontario. “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.”