TearLab Osmolarity System cleared by FDA

The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of patients with signs or symptoms of Dry Eye Disease (DED) in conjunction with other methods of clinical evaluation. It is now in a position to be marketed to clinincal facilities in the United States, having received its FDA 510(k) clearance.

“Eye care practitioners will now have the ability to use quantitative data to aid in the diagnosis of DED at the point of care. The TearLab Osmolarity System will aid in the diagnosis of DED and improve our ability to manage these patients,” commented Dr. Richard Lindstrom. Dr. Lindstrom is Adjunct Professor Emeritus for the University of Minnesota Dept. of Ophthalmology and is the Founder and Attending Surgeon at Minnesota Eye Consultants.Dry Eye Disease afflicts approximately 100 million people worldwide. In the US, less than 5% of the DED patient population has been diagnosed and is being treated, according to Healthcare Maintenance Organizations data.“This 510(k) clearance is a significant milestone for our Company and validates the performance of our TearLab Osmolarity System for use as an aid in the diagnosis of Dry Eye Disease. Given that DED is a continuum, it is critical to diagnose and treat patients early in disease progression. We hope the TearLab will change the practice paradigm for eye care physicians in how they diagnose the DED patient population. The market for DED products is growing rapidly and there are over 20 novel therapeutic compounds being developed for the treatment of DED. We are excited to participate in the expanding commercial opportunities in eye care,” commented Eric Donsky, CEO of TearLab Corporation.