FDA to Review Device-Based Approach for Tear Production
Allergan announced the submission of a de novo application to the Food and Drug Administration (FDA) for the Oculeve Intranasal Tear Neurostimulator device.
According to the FDA, this application process provides controls to assure the safety and effectiveness of medical devices for which there is no legally marketed predicate device.
The Oculeve Intranasal Tear Neurostimulator is being investigated as the first and only neurostimulation device to increase tear production in patients with dry eye disease due to decreased tear production. Allergan recently announced positive data from two pivotal trials showing that the device met the primary and secondary endpoints in both studies.
The Oculeve Intranasal Tear Neurostimulator is a handheld device, with daily disposable tips, that increases tear production upon stimulation.
For more information visit Allergan.com.