Allergan: Oculeve Intranasal Tear Neurostimulator Trials Met Efficacy Endpoints

(RTTNews) - Botox maker Allergan plc (AGN) announced Monday that two pivotal trials of the Oculeve Intranasal Tear Neurostimulator, OCUN-009 and OCUN-010, each met their primary and secondary efficacy endpoints.

With these new results, a premarket submission for the device is on-track to be submitted to the Food and Drug Administration or FDA in the second half of 2016.

The company noted that this handheld stimulator and daily disposable tips increases tear production upon stimulation in patients with Dry Eye Disease due to decreased tear production. There have been several Oculeve Intranasal Tear Neurostimulator clinical studies completed with more than 200 adult patients, showing positive safety and efficacy of the device.

The OCUN-009 study is a prospective, randomized, controlled, double-masked, multicenter, cross-over trial in which participants used an active device and two control applications.

The OCUN-010 study design is a prospective, single-arm, multicenter, open-label clinical trial in which participants used the Oculeve Intranasal Tear Neurostimulator to stimulate tear production for 180 days.

David Nicholson, Chief R&D Officer, at Allergan, said, "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."