Allergan's Pivotal Trials Of Oculeve Intranasal Tear Neurostimulator Meet Primary And Secondary Efficacy Endpoints

Allergan plc AGN revealed Monday that two pivotal studies of the Oculeve Intranasal Tear Neurostimulator, OCUN-009 and OCUN-010. The company said the results met their primary, as well as the secondary efficacy endpoints. As a result, the company claimed it was the first and only neurostimulation device for boosting tear production in dry eye disease.

Allergan indicated that due to the fresh results, a premarket submission for the device was on-track to be submitted to the FDA in the United States in the second half of the current year.

The drug firm indicated that this handheld stimulator, which is daily disposal tips, boost tear production upon stimulation in patients with Dry Eye Disease because of the reduced tear production. The company added that there were a number of Oculeve Intranasal Tear Neurostimulator clinical trials completed with over 200 adult patients, showing positive safety and efficacy of the device.

Allergan's Chief R&D Officer, David Nicholson, reacted to say, "We are excited with the outcome of these two sets of pivotal data. The Oculeve Intranasal Tear Neurostimulator is a novel approach and has the potential to help patients suffering from dry eye by increasing their natural tears. This device is part of Allergan's strong eye care development pipeline and will complement our leading dry eye treatment RESTASIS®. This is a major step forward in providing a promising new option for eye care professionals and their patients with dry eye disease."

The company indicated that its OCUN-009 study was a prospective, randomized, controlled, double-masked, multicenter, cross-over trial where participants used an active device and two control applications. The drug maker said that the primary effectiveness endpoint of increased tear production over basal during intranasal application was met as measured by Schirmer score compared to both controls.

The European firm said the OCUN-010 study design was a prospective, single-arm, multicenter, open-label clinical trial where participants used the Oculeve Intranasal Tear Neurostimulator to stimulate tear production for 180 days. Allergan said that the primary effectiveness endpoint of boosted tear production was met as measured by Schirmer score during application of the device compared with basal Schirmer score at Day 180.

Also, secondary endpoints of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at Days 0, 7, 30 and 90 were met. The company indicated that all device-related adverse events were mild in nature and that there were no device-related serious adverse events.