Allergan (NYSE: AGN) said today it won FDA clearance for its TrueTear intranasal tear neurostimulator designed to stimulate tear production, touting it as the 1st of its kind.
The TrueTear device is designed to be inserted into the nasal cavity to induce the production of tears, the company said.
“TrueTear represents a technological breakthrough for eye care professionals as it delivers an effective, non-invasive and drug-free way to temporarily increase tear production. 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,” Allergan chief R&D officer David Nicholson said in a press release.
Approval came based on 2 clinical studies of the device, Allergan said, which showed that the device can increase tear production in adults with aqueous tear deficiency. A total of 145 patients were examined in the 2 trials, both of which met their primary endpoints and reported device-related adverse events that were mild in nature, with no serious adverse events reported.
“In clinical trials, TrueTear demonstrated increased tear production upon stimulation of the nasal cavity. 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,” Dr. John Sheppard of the Eastern Virginia Medical School said in a prepared statement.
In February, Allergan said it inked a deal to pick up Zeltiq Aesthetics Inc. (NSDQ:ZLTQ) and its portfolio of body-contouring products for $2.48 billion.
Zeltiq’s FDA-approved CoolSculpting system uses a cooling mechanism to reduce the appearance of fat which has not responded to diet or exercise, without disturbing surrounding tissue.
