OccuLogix, Inc.

OccuLogix, Inc.

November 11, 2008 10:01 ET

Positive Data From the TearLab™ Osmolarity System 510K Submission Presented Today at the American Academy of Ophthalmology (AAO) and European Society of Ophthalmology (SOE) 2008 Joint Meeting

TORONTO, ONTARIO--(Marketwire - Nov. 11, 2008) - OccuLogix, Inc. (NASDAQ:OCCXD)(TSX:OC) announced that Dr. Richard Lindstrom, MD, today presented data demonstrating clinical performance, usability and safety data for the TearLab Osmolarity System. The data is derived from the recent 510(k) filing to the US Food and Drug Administration (the FDA) for clearance to market the TearLab™ Osmolarity System and the TearLab™ Osmolarity Test Card in the United States. 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 Occulogix.

Clinical Validation

The objective of the 510(k) submission study was to validate the performance of the TearLab™ Osmolarity System when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from 234 volunteer subjects in three study sites.

Performance-Precision and Accuracy

The study demonstrated that the TearLab System was able to measure the osmolarity of tears with the same accuracy as a laboratory osmometer, with a correlation of 0.95%.

The TearLab which takes only seconds to perform, and is noninvasive was also found to be precise, exceeding the industry standards set by other point-of-care tests such as glucose and cholesterol. These outstanding performance characteristics were achieved while only using a fraction of the volumes typically needed to perform diagnostic assays.


To assess ease of use, TearLab operators were allowed to only read the operation manual, and with no additional training or assistance were tasked to collect tears and performed the TearLab osmolarity test on both eyes of 234 subjects. Operators collected tears successfully 468 times out of 468 attempts. TearLab received an average 4.8 of 5.0 agreement rating with statements that the TearLab was easy to use.


Tear collection using the TearLab Osmolarity System was found to be safe, as there were no reports of corneal or conjunctival trauma over 234 subjects and 468 eyes. No discomfort due to tear collection was reported 24 hours post-collection.

Following the data presentation Dr. Lindstrom remarked, "Quality vision requires a healthy tear film. I am excited about the new TearLab Osmolarity System, as I believe it will enhance my ability to diagnose and manage ocular surface disease in the surgical patient, improving their visual outcome , comfort and quality of life."

Eric Donsky, CEO of OccuLogix also expressed his appreciation to Gary Foulks, MD, Kelley Nichols, MD, FAAO and David Geffen, OD, FAAO our clinical sites investigators for doing a tremendous job in this trial.

The TearLab™ Osmolarity System

The TearLab™ Osmolarity System uses a novel 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. The TearLab™ system can produce a sample-to-answer result in less than 30 seconds and is simple enough to be operated by a technician.

About OccuLogix, Inc.

OccuLogix (www.occulogix.com) is a healthcare company focused on ophthalmic devices for the diagnosis and treatment of age-related eye diseases. Its wholly-owned subsidiary, OcuSense, Inc. (www.ocusense.com), is an in-vitro diagnostics company developing and commercializing novel, laboratory-on-a chip technologies that enable eye care practitioners to test for highly sensitive and specific biomarkers in tears at the point-of-care.

Forward-Looking Statements

This press release may contain forward-looking statements. These statements relate to future events and are subject to risks, uncertainties and assumptions about the Company. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement, including the factors detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Forms 10-K and 10-Q. We do not undertake to update any forward-looking statements.

1. Tomlinson A, Khanal S, Ramaesh K, Diaper C, McFadyen A. Tear film osmolarity: determination of a referent for dry eye diagnosis. Invest Ophthalmol Vis Sci 47:4309-15, 2006.

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