Allergan submits application to FDA for Oculeve intranasal tear neurostimulator
Allergan has filed a de novo application to the FDA for the Oculeve intranasal tear neurostimulator, according to a company press release.
The hand-held stimulator can temporarily increase tear production in patients with dry eye disease due to decreased tear production.
“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,” David Nicholson, chief research and development officer at Allergan, said in the release.
Allergan recently announced that the device met its effectiveness endpoints in two pivotal trials.