Allergan Granted Marketing Authorization by the FDA for TrueTear Intranasal Neurostimulating Device
Allergan announced that it has been granted marketing authorization from the FDA for TrueTear Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients, according to a company news release.
TrueTear is a handheld stimulator with daily disposable tips that is inserted into the nasal cavity to induce the production of tears. There have been two clinical studies showing positive safety and effectiveness of the device in the increase of tear production completed with 145 aqueous deficient dry eye adult patients.
"TrueTear represents a technological breakthrough for eye care professionals as it delivers an effective, noninvasive and drug-free way to temporarily increase tear production,” David Nicholson, Chief R&D Officer, at Allergan, said in the news release. “As an innovator in eye care, we are continually looking for new products to offer through our portfolio, and TrueTear represents the next step forward.”
Last May, Allergan announced positive results from two pivotal trials for TrueTear that showed an increase in tear production upon nasal neurostimulation in adults with aqueous tear deficiency.
“In clinical trials, TrueTear demonstrated increased tear production upon stimulation of the nasal cavity,” John Sheppard, MD, MMSc, professor of Ophthalmology, Eastern Virginia Medical School and president of Virginia Eye Consultants, said in the news release. “Interestingly, neurostimulation has been used as an approach for a wide variety of disorders for more than 30 years. TrueTear™ is the first of its kind to provide a temporary increase in tear production in this way.”
About the Studies
Study 1 is a prospective, randomized, controlled, double-masked, multicenter, cross-over trial in which participants used an active device and two control applications. The primary effectiveness endpoint of increased tear production during intranasal application as measured by Schirmer score compared to both controls was met. Study 2 is a prospective, single-arm, multicenter, open-label clinical trial in which participants used TrueTear™ to stimulate tear production for 180 days. The primary effectiveness endpoint of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at Day 180 was met. Secondary endpoints of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at Days 0, 7, 30 and 90 were also met. The direct clinical benefit of temporarily increasing tear production as a therapy for patients with dry eye disease was not assessed as part of these clinical trials. All device-related adverse events were mild in nature. There were no device-related serious adverse events.
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