Meibomian gland dysfunction treatment shows positive results in phase 2b study
Click Here to Manage Email Alerts
AZR-MD-001 ophthalmic ointment showed positive 3-month safety and efficacy results for the treatment of meibomian gland dysfunction, according to a press release from Azura Ophthalmics.
The multicenter, double-masked, vehicle-controlled, parallel-group phase 2b study investigated AZR-MD-001 0.5%, applied twice weekly to the lower eyelid at bedtime, in 245 participants with meibomian gland dysfunction (MGD). The ointment met the co-primary endpoints of improvements in meibomian glands yielding liquid secretion (1.8 more open glands secreting meibum from baseline; P = .0004) and Ocular Surface Disease Index score (average improvement of 3.5 from baseline; P = .0438) compared with vehicle.
Source: Adobe Stock.
Other clinically meaningful endpoints included improvements in meibum quality, tear stability and patient-reported outcomes.
AZR-MD-001 was well tolerated overall. The majority of adverse events were mild and transient, with no reports of serious treatment-related adverse events; 2.4% of participants discontinued AZR-MD-001 because of treatment-emergent adverse events.
“These data clearly demonstrate consistency in efficacy across multiple sign and symptom endpoints,” Marc Gleeson, CEO of Azura, said in the release. “With as little as four applications of AZR-MD-001, improvement in glandular function was observed and continued to improve over 3 months.”
Azura expects to advance AZR-MD-001 to a pivotal phase 3 clinical trial for MGD in 2023.
Read more about
Click Here to Manage Email Alerts