OccuLogix Submits 510(k) Premarket Notification for the Tearlab(TM) Osmolarity System

  OccuLogix, Inc. (NASDAQ: OCCXD)(TSX: OC) announced today that its subsidiary, OcuSense, Inc., has submitted its 510(k) premarket notification to the US Food and Drug Administration (the FDA) for clearance to market the TearLab(TM) Osmolarity System and the TearLab(TM) Osmolarity Test Card in the United States.

As previously disclosed, the TearLab(TM) system recently obtained CE Marking and is currently being sold and marketed in five European countries through exclusive distributor agreements. In the United States, prior to 510(k) clearance from the FDA, the system is available for research use only.

Clinical Validation

The regulatory application included a study that validated the performance of the TearLab(TM) Osmolarity System when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from volunteer subjects. The study looked at:

- Usability

- Safety

- Clinical performance

The study involved three sites and enrolled 234 patients. The Company expects to release top-line data from the study at the American Academy of Ophthalmology (AAO) and European Society of Ophthalmology (SOE) 2008 Joint Meeting in November.

"We are pleased to reach this significant milestone," commented Eric Donsky, CEO of OccuLogix. He further remarked, "We are looking forward to the FDA review of our submission and the opportunity to provide eye care practitioners with the ability to use quantitative physiological data at the point of care with the TearLab(TM) Osmolarity System".

Benjamin Sullivan Ph.D., Chief Scientific Officer of OccuLogix, commented, "The TearLab(TM) system has been shown to eliminate the effects of evaporation and sample transfers on nanoliter osmolarity measurements. The TearLab(TM) system allows lab technicians to obtain the quantitative measurement of tear osmolarity, and the speed of the test lets it integrate seamlessly into the clinical workflow."

The TearLab(TM) Osmolarity System

The TearLab(TM) 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(TM) Osmolarity System eliminates the challenges that previously prevented point-of-care osmolarity testing. The TearLab(TM) 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

Contacts: OccuLogix, Inc. Eric Donsky Investor Relations [phone] Email: [e-mail] Website: www.occulogix.com All other inquiries: Tracy Puckett [phone] Email: [e-mail]