May 21, 2009 (FinancialWire) — OccuLogix, Inc. dba TearLab Corp. (NASDAQ: TEAR) (TSX: TLB) has received FDA 510(k) clearance for its TearLab Osmolarity System.

The TOS is intended to measure the osmolarity of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation. The 510(k) clearance allows the company to begin market activities in the U.S. to clinical facilities categorized as high or moderate complex under the Clinical Laboratory Improvement Act of 1988 (CLIA ‘88).

Dry eye disease is a chronic, progressive disease that afflicts approximately 40 million people in the United States and 100 million worldwide, according to some estimates. 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.

Osmolarity is an objective and quantitative biomarker that is central to the disease pathogenesis of DED. Consequently, osmolarity is a highly specific and sensitive endpoint for this disease.

Dry eyes are the most common complication from LASIK, with approximately half the patients having that adverse reaction in the first week after surgery. In addition, symptoms of dryness are the number one reason cited for contact lens drop outs. Early disease diagnosis may prove to be a valuable clinical tool in these patient populations.

OccuLogix dba TearLab Corp. is an in-vitro diagnostics company that develops and commercializes a proprietary tear testing platform, TearLab(tm), for use in the physician and clinical office.

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