TearLab Corporation Announces FDA 510(k) Clearance of the TearLab(tm) Osmolarity...
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TearLab Corporation Announces FDA 510(k) Clearance of the TearLab(tm) Osmolarity
System
SAN DIEGO, May 19, 2009 (GLOBE NEWSWIRE) -- OccuLogix, Inc. dba TearLab
Corporation (Nasdaq:TEAR) (TSX:TLB) an ophthalmic, in-vitro diagnostics company,
today announced FDA 510(k) clearance of its award winning 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 (CLIA '88).
"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. 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(1). 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(2).
"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.
Dry Eye Disease and Osmolarity
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. Moreover, tear osmolarity has been shown to
have a high accuracy and predictive value for diagnosing DED(1).
Decades of peer-reviewed, scientific data validates osmolarity's superiority to
conventional DED diagnostic tests, such as the Schirmer test, tear film break-up
time, and ocular surface staining.
Dry eyes are the most common complication from LASIK, with approximately half
the patients having that adverse reaction in the first week after surgery(3). 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.
The Company also intends to begin studies for CLIA Waiver categorization, with
expected data submission to the FDA in the third quarter of 2009.
About the TearLab Osmolarity System
The TearLab(tm) 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(tm)
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.
About OccuLogix, Inc. dba TearLab Corporation
OccuLogix dba TearLab Corporation (www.tearlab.com) 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. The Company employs
lab-on-a-chip technologies (integrating one or several laboratory functions on a
chip only millimeters in size) that enable healthcare practitioners to rapidly
test for highly sensitive and specific biomarkers in tears at the point-of-care.
Headquartered in San Diego, CA and with offices in Milton, Ontario and
Alpharetta, GA, TearLab Corporation's common shares trade on the NASDAQ Capital
Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the
symbol 'TLB'. TearLab received the CE Mark for its TearLab(tm) Osmolarity System
in 2008 and is currently marketed in 14 countries globally.
Forward-Looking Statements
This press release may contain forward-looking statements, including statements
regarding the growth of the market for DED products, the impact of our product
on the management of affected patients, and our intention to seek CLIA Waiver.
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.
References:
1. Definition and Classification of Dry Eye. Report of the Diagnosis and
Classification Subcommittee of the Dry Eye Workshop (DEWS). The Ocular Surface
2007;5(2);75-92.
2. Yazdani C, McLaughlin T,Smeeding JE, Walt J. Prevalence of treated dry eye
disease in a managed care population. Clin Ther 2001;23:1672-2.
3. Hovanesian et al, J Cataract Refract Surg. 2001 Apr;27(4):577-84) and 20%
persisting more than 6 months (Shoja & Beharati, Eur J Ophthalmol. 2007
Jan-Feb;17(1):1-6.
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CONTACT: TearLab Corporation
Investor Relations:
Eric Donsky, CEO
858-794-1422
edonsky@tearlab.com
Media Inquiries:
Tracy Puckett
678-566-3829
tpuckett@tearlab.com
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