Allergan plc announced yesterday positive results from two clinical
trials that evaluated the safety and effectiveness of the Oculeve
Intranasal Tear Neurostimulator.
The device consists of a handheld stimulator with daily disposable tips. It increases tear production in patients with dry eye disease. Chronic dry eye may be caused by age, contact lenses, eye diseases, medications or the environment. The eyes don't produce enough tears, which can result in dry spots on the cornea. More than 25 million people suffer from chronic dry eye.
"We are excited with the outcome of these two sets of pivotal data," Allergan's Chief R&D Officer David Nicholson 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."
More than 200 patients have participated in several clinical trials of the Oculeve Intranasal Tear Neurostimulator. With the positive results of OCUN-09 and OCUN-010, Allergan will proceed with a premarket submission to the U.S. Food and Drug Administration (FDA).
Alerts Sign-up