Azura MGD treatment meets primary endpoints in phase 2 trial
Significant improvement in signs and symptoms of meibomian gland dysfunction were achieved with AZR-MD-001, a topical ointment, thus meeting the primary endpoints of the drug’s phase 2 trial, Azura Ophthalmics announced in a press release.
In the multicenter, double-masked, vehicle-controlled, integrated analysis of four separate phase 2 studies, safety and efficacy of AZR-MD-001 were analyzed for doses of 0.1%, 0.5% and 1% in 95 patients.
Statistically significant reduction of symptoms as measured by Ocular Surface Disease Index scores was demonstrated in the 0.5% and 1% groups (both P < .01) and in the 0.5% group (P < .05) at 3 months, according to the release. Additionally, after 3 months of treatment, a statistically significant proportion of patients, up to 58% (P < .05), were non-symptomatic compared with 16% of patients in the control group.
Up to 46% of patients achieved a clinically meaningful increase in the number of glands secreting meibum compared with 8% in the control group, the release said.
No serious ocular treatment emergent adverse events were reported. Application site irritation, stinging on application and watery eyes were reported only in the 1% dose group.