FDA 510(k) Clearance of the TearLab Osmolarity System

OccuLogix, Inc. dba TearLab Corporation has received FDA 510(k) clearance of its TearLab Osmolarity System. 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. The 510(k) clearance allows the Company to immediately begin market activities in the U.S. to clinical facilities categorized as high or moderate complex under the Clinical Laboratory Improvement Act of 1988.

"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," comments 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. Dr. Lindstrom serves on the Board of Directors of TearLab Corporation.

Dry Eye Disease is a chronic, progressive disease that afflicts approximately 40 million people in the United States and 100 million worldwide. In the U.S., 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," comments Eric Donsky, CEO of TearLab Corporation.

About the TearLab Osmolarity System
The TearLab Osmolarity System uses a revolutionary lab-on-a-chip approach that requires less than 50 nL (nanoliters) of tear fluid in order to measure tear osmolarity. By using such a small amount of tears, the TearLab Osmolarity System eliminates the challenges that previously prevented point-of-care osmolarity testing. TearLab(tm) can produce a sample-to-answer result in less than 30 seconds and is simple enough to be operated by a technician, greatly improving patient throughput in the office setting.

http://www.tearlab.com