APR 26, 2017
The FDA has approved TrueTear, an intranasal tear neurostimulator device designed to temporarily increase tear production in adult patients.
The handheld stimulator comes with daily disposable tips that are inserted into the nasal cavity for an effective, non-invasive and drug-free way to induce the production of tears.
Dr. Richard Lewis, who served as a clinical trial investigator, believes the novel device will be a game changer. In an interview last month, Lewis said his patients were so pleased with the results, they refused to give the device back.
Last May, Allergan announced the device met primary and secondary endpoints in 2 studies, significantly increasing tear production in adults with aqueous tear deficiency. The first trial was a prospective, randomized, controlled, double-masked, multicenter, cross-over trial in which participants used an active device and 2 control applications. The second trial was a separate multicenter, open-label clinical trial in which participants used the neurostimulator to stimulate tear production for 180 days.
All device-related adverse events were mild, including nasal pain, discomfort or burning (10.3%); transient electrical discomfort (5.2%) and nosebleed (5.2%).
The device was originally developed by Oculeve, a San Francisco-based biotech which was purchased by Allergan in a $125-million deal in August 2015.