MAY 18, 2016
Two separate clinical trials show that the Oculeve intranasal tear neurostimulator significantly increases tear production in patients with dry eye due to decreased tear production.
The company says the device, which consists of a handheld stimulator and daily disposable tips, met primary and secondary efficacy endpoints in two studies: a prospective, randomized, controlled, double-masked, multicenter, cross-over trial in which participants used an active device and two control applications, and in a separate multicenter, open-label clinical trial in which participants used the neurostimulator to stimulate tear production for 180 days.
Device-related adverse events were generally mild. No patient discontinued treatment due to adverse events. Allergan says FDA submission is on-track for the second half of 2016.