Melbourne-linked biopharmaceutical company Azura Ophthalmics has announced positive results from a Phase 2 clinical trial of its investigational dry eye therapy AZR-MD-001 in patients with contact lens discomfort (CLD).
The multicentre, vehicle-controlled study achieved topline efficacy and safety results at three months.
Sixty-seven participants were recruited who could not comfortably wear their lenses as desired and who demonstrated signs of meibomian gland dysfunction (MGD), a leading cause of dry eye disease and CLD.
The trial met its primary endpoint of showing a statistically significant improvement in number of open meibomian glands. Patients in the AZR-MD-001 arm gained at least three hours of comfortable contact lens wear time daily.
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 also reported to be safe and well tolerated with all observed adverse events being mild to moderate in severity and none resulting in treatment discontinuation.
Azura said 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,” Mr Marc Gleeson, CEO of Azura, said.
“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.”
Mr Lyndon Jones, director and professor at the Centre for Ocular Research & Education in Ontario, Canada, said that many patients have given up on wearing contact lenses altogether due to discomfort and with innovation in this space stalling, AZR-MD-001 addresses this by treating the underlying causes of CLD.
“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.”
Azura is expecting to advance AZR-MD-001 into Phase 3 studies.