AZR-MD-001 improves signs, symptoms of meibomian gland dysfunction, topline data show
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Azura Ophthalmics announced positive topline results from its phase 2 study of AZR-MD-001 in patients with contact lens discomfort and signs of meibomian gland dysfunction.
“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,” Lyndon Jones, PhD, BSc, DSc, FCAHS, FCOptom, DipCLP, DipOrth, FAAO, FIACLE, FBCLA, director and professor at the Centre for Ocular Research & Education at the University of Waterloo, said in an Azura press release. “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.”
According to the release, the multicenter, vehicle-controlled study included 67 participants who self-administered AZR-MD-001 0.5%, a selenium sulfide-based ophthalmic ointment preparation, or its vehicle to the lower eyelid at night twice weekly for 3 months. The study met its primary endpoint of showing significant improvement in meibomian glands yielding liquid secretion (MGYLS), as well as secondary endpoints of improved meibum quality, tear stability, ocular surface staining and contact lens wear time.
The study also demonstrated that AZR-MD-001 was safe and well-tolerated, with mild to moderate adverse events, none of which resulted in treatment discontinuation, the company stated.
“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 3 hours every day over their normal wear time,” Azura CEO Marc Gleeson said in the release. “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.”
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