Allergan has unveiled a new neurostimulation device called TrueTear, which can temporarily increase the production of natural tears through neurostimulation in adult patients.
The US Food and Drug Administration (FDA) approved the handheld device in 2017 for use during neurostimulation procedures, where it is inserted into the nasal cavity to trigger tear production.
TrueTear has been designed as a drop-free and drug-free alternative to current tear-inducing methods. It employs small energy pulses to send nerve signals to the brain, which in turn transmits the signals to tear glands present around the eyes.
Allergan US Eye Care senior vice-president Jag Dosanjh said: “We are excited to add this drug-free, drop-free treatment option for adult patients with inadequate tear production to our current portfolio.
“TrueTear continues the proud heritage of our foundational philosophy: to bring innovative treatments to patients around the world.”
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The safety and effectiveness of the neurostimulation device were evaluated in two clinical trials that met the primary endpoint of increased tear production upon intranasal use in a total of 145 subjects suffering from aqueous deficient dry eye.
One trial was controlled, double-masked and cross-over, while the second trial had a single-arm, open-label design. The device-related adverse effects during the trials were observed to be mild.
Eastern Virginia Medical School Ophthalmology professor John Sheppard said: “As seen in clinical trials and in my own post-approval experience treating patients, TrueTear provides tiny pulses of energy within the nasal cavity to create tears and may be appropriate for most patients with inadequate tear production.”
The device was officially launched at the 2018 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators annual meetings.