Allergan Files de novo Application for Approval of Oculeve Intranasal Tear Neurostimulator

Allergan plc

disclosed that it filed the de novo application for the Oculeve Intranasal Tear Neurostimulator device with the FDA in the United States. The company quoted the regulator and said that this process offered a pathway for medical devices for which general or special controls provided a reasonable assurance of safety, as well as, effectiveness. However, there is no legally marketed predicate device, according to the company. Allergan said that this handheld stimulator was examined for temporarily increasing tear production upon activation in patients with dry eye disease as a result of decreased tear production. The company revealed recently that two pivotal studies of the Oculeve Intranasal Tear Neurostimulator each met their effectiveness endpoints. The company's Chief R&D Officer, David Nicholson, said, "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.". The drug maker indicated that Oculeve Intranasal Tear Neurostimulator would support its strong existing dry eye portfolio, as well as, offer physicians with a significant opportunity to treat more patients through this novel, device-based approach. The stock traded down by 0.38 percent on Monday.