Novel Tear Production Stimulator Given All Clear by FDA
Allergan has been granted marketing authorization from the Food and Drug Administration (FDA) for TrueTear Intranasal Tear Neurostimulator, making it the first FDA-cleared device to temporarily increase tear production.
TrueTear induces the production of tears through a handheld stimulator that utilizes disposable tips which are inserted into the nasal cavity. Safety and efficacy of the TrueTear device were demonstrated in two clinical studies in a total of 145 individuals with aqueous deficient dry eye.
“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,” said David Nicholson, Allergan Chief R&D Officer.
The results of the two clinical studies were released last May. In Study 1 patients were randomized to the active device or two control applications. The primary endpoint of increased tear production during application of the device versus both controls, was met, as measured by Schirmer score. Study 2 was an open label trial which met its primary endpoint of increased tear production at day 180, as measured by Schirmer score compared to basal Schirmer score.
Adverse events experienced during the trials included nasal pain, discomfort or burning (10.3%), transient electrical discomfort (5.2%), nosebleed (5.2%), and nasal congestion (3.1%).
For more information visit Allergan.com.