Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced the official launch of TrueTear, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.
TrueTear is a handheld neurostimulation device with disposable tips that is inserted into the nasal cavity to induce the production of natural tears, is a novel and innovative approach for those patients with inadequate tear production. In two clinical trials, TrueTear was shown to be safe and effective for temporarily increasing tear production in adult patients.
In those trials OCUN 009 and OCUN 010, subjects using TrueTear did experience significantly increased tear production using the device. At least one anecdotal report we located said that, “my eyes felt fantastic for hours after my TrueTear treatment.”
The FDA De Novo classification request is here
The neurostimulation device will be officially launched during the 2018 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators annual meetings being held April 13-17 in Washington, DC.
"TrueTear is the latest in a long line of innovations that have helped make Allergan a leading global eye care company. We are excited to add this drug-free, drop-free treatment option for adult patients with inadequate tear production to our current portfolio. This milestone truly represents our company's ongoing commitment to developing eye care products that help improve the lives of patients," said Jag Dosanjh, Senior Vice President, US Eye Care. "For more than 70 years, Allergan has remained focused on delivering the most innovative eye care products in the industry. TrueTear continues the proud heritage of our foundational philosophy: to bring innovative treatments to patients around the world."
The prevalence of dry eye disease is approximately 7% of the population in the US and increases with age. One study found the prevalence was 14.4% in the age group 48 – 91.