Allergan plc has filed with the US Food and Drug Administration (FDA) the de novo application for the Oculeve Intranasal Tear Neurostimulator device. According to the FDA, 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.
Dry eye disease affects over 31 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.
Allergan plc is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.