Allergan Files With FDA For Approval Of Oculeve Intranasal Tear Neurostimulator

(RTTNews) - Allergan plc (AGN) said it has filed with the U.S. Food and Drug Administration the de novo application for the Oculeve Intranasal Tear Neurostimulator device. The company noted that it is a first of its kind approach to increase tear production in patients suffering from eye disease.

According to the FDA, this process provides a pathway for medical devices for which general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

Allergan said that the handheld stimulator was investigated for temporarily increasing tear production upon activation in patients with dry eye disease due to decreased tear production. Recently, the company announced that two pivotal trials of the Oculeve Intranasal Tear Neurostimulator each met their effectiveness endpoints.

The Oculeve Intranasal Tear Neurostimulator will complement Allergan's existing dry eye portfolio and provide physicians with a significant opportunity to treat more patients through this device-based approach.