Allergan has received approval from the US Food and Drug Administration (FDA) for its TrueTear intranasal tear neurostimulator.
TrueTear is claimed to be the only FDA approved device, which will temporarily increase tear production during neurostimulation in adult patients.
TrueTear, which is a handheld stimulator with daily disposable tips, can be inserted into the nasal cavity to induce the production of tears.
Two clinical studies have demonstrated the safety and efficacy of TrueTear device to increase tear production in 145 aqueous deficient dry eye adult patients.
Allergan’s study 1 is a prospective, randomized, controlled, double-masked, multicenter and cross-over trial, which included patients using an active device and two control applications.
The primary effectiveness endpoint of increased tear production during intranasal application was met when compared to Schirmer score with both controls.
Allergan’s study 2 is a prospective, single-arm, multicenter and open-label clinical trial, in which patients used TrueTear to stimulate tear production for 180 days
According to the company, 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.
Allergan chief R&D officer David Nicholson 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."
Image: Allergan’s TrueTear intranasal neurostimulating device. Photo: courtesy of ALLERGAN.