Allergan plc, a global pharmaceutical company, announced 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 (FDA) in the second half of 2016.
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.
"We are excited with the outcome of these two sets of pivotal data," said David Nicholson, chief R&D officer, at Allergan. "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 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 primary effectiveness endpoint of increased tear production over basal during intranasal application as measured by Schirmer score compared to both controls was met. 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. The primary effectiveness endpoint of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at Day 180 was met. 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 also met. All device-related adverse events were mild in nature. There were no device-related serious adverse events. No patients discontinued treatment due to adverse events.
Chronic dry eye is a disease that affects over 25 million people. It can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions or environmental factors. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea.
The Oculeve Intranasal Tear Neurostimulator is limited by United States law to investigational use.