Allergan plc (NYSE: AGN) announced that it has filed with the U.S. Food and Drug Administration (FDA) the de novo application for the Oculeve Intranasal Tear Neurostimulator device. According to theFDA, this process provides a pathway for medical devices for which general and/or special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
This handheld stimulator was investigated for temporarily increasing tear production upon activation in patients with dry eye disease due to decreased tear production. Recently Allergan announced that two pivotal trials of the Oculeve Intranasal Tear Neurostimulator each met their effectiveness endpoints.
“The Oculeve Intranasal Tear Neurostimulator is an exciting potential option for patients suffering from dry eye disease, and we are pleased to have filed the de novo application with FDA that will allow patients to gain access to this novel medical device,” said David Nicholson, Chief R&D Officer, at Allergan.
The Oculeve Intranasal Tear Neurostimulator will complement Allergan’s robust existing dry eye portfolio and provide physicians with a significant opportunity to treat more patients through this novel, device-based approach.