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Intranasal stimulator increased tear production in trials
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Allergan announced that a premarket submission for Oculeve Intranasal Tear Neurostimulator will be submitted to the FDA in the second half of 2016, following two pivotal trials that met their primary and secondary efficacy endpoints.
The handheld stimulator and daily disposable tips increase tear production upon stimulation in patients with dry eye disease due to decreased tear production, according to a press release from the company.
The OCUN-009 study is a prospective, randomized, controlled, double-masked, crossover trial where participants used an active device and two control applications. The endpoint of increased tear production over baseline during intranasal application as measured by Schirmer’s score compared to both controls was met, according to the release.
OCUN-010 is a prospective, single-arm, multicenter, open-label clinical trial where participants used Oculeve to stimulate tear production for 180 days. The primary endpoint of increased tear production, as measured by Schirmer’s score and compared with baseline Schirmer’s score at day 180 was met. Increased tear production (Schirmer’s score) compared with baseline Schirmer’s score at days 0, 7, 30 and 90 were also met.
Patients experienced no device-related serious adverse events.