SAN DIEGO, Oct. 17, 2017 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (“TearLab” or the “Company”) today provided an update on the regulatory strategy for its TearLab Discovery™ System, the Company’s next-generation in-vitro diagnostics testing platform. Based on a reassessment of its regulatory and reimbursement considerations, the Company has elected to pursue initial U.S. Food and Drug Administration (FDA) clearance of a test card measuring a single inflammatory biomarker, MMP-9, in combination with our FDA cleared osmolarity test.
TearLab had previously planned to seek clearance of a test card containing a total of two inflammatory biomarkers plus osmolarity to aid in the diagnosis and management of dry eye disease. This change in regulatory strategy is not expected to impact the prior guidance in relation to the timing of the filing of the Company’s FDA 510(k) application for clearance of the TearLab Discovery™ System. The Company remains on track to submit its application by the end of 2017. Additionally, the Company believes that the revised strategy can reduce the review period of the application since the inflammatory biomarker selected, MMP-9, has an FDA cleared predicate.
Both the osmolarity and MMP-9 biomarkers have existing quantitative reimbursement codes in the U.S., which the Company believes will provide immediate and favorable reimbursement upon commercial launch.
“Based on a comprehensive review of the best regulatory and reimbursement outcome for our first test on the Discovery™ System, we determined that seeking initial clearance of a single inflammatory biomarker in combination with our osmolarity test, will provide the most expeditious regulatory path as well as increased clarity on reimbursement expectations,” said Seph Jensen, TearLab’s Chief Executive Officer. “We are excited about the clinical and commercial potential of our Discovery™ System and believe that our updated U.S. regulatory strategy is the best path forward for our first test on the new platform. Furthermore, we remain committed to incorporating additional biomarkers through the Discovery platform that bring value to doctors and patients in the diagnosis and management of a variety of eye diseases.”
About TearLab Corporation
TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. 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'.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among others, statements concerning the potential reimbursement rates for our TearLab Osmolarity System test in the U.S., the potential U.S. regulatory clearance of the TearLab Discovery™ System in the U.S. as well as the market perception, acceptance and our ability to successfully develop and commercialize the TearLab Discovery™ System and the TearLab Osmolarity System. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are based on management’s current, preliminary expectations and are subject to various risks and uncertainties. Many factors, risks and uncertainties may cause our actual results to differ materially from forward-looking statements, including the factors, risks, and uncertainties detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 10, 2017,and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, filed with the SEC on August 14, 2017. We do not undertake to update any forward-looking statements except as required by law.
The Ruth Group