SAN DIEGO, April 11, 2018 (GLOBE NEWSWIRE) -- TearLab Corporation (OTCQB:TEAR) (“TearLab” or the “Company”) today announced that it has received written feedback from the Food and Drug Administration (FDA) on the requirements for 510(k) clearance of its TearLab Discovery™ Platform and test card measuring the inflammatory biomarker, MMP-9.
The FDA-cleared predicate chosen to establish 510k substantial equivalence measures the biomarker qualitatively, while the intended use of the TearLab Discovery MMP-9 test in the submission measures the biomarker quantitatively. The agency has requested that the company provide additional information to establish correlation to the predicate.
“The FDA’s feedback to our submission for the TearLab Discovery™ Platform was very helpful in establishing the steps needed to demonstrate substantial equivalence through the 510k process,” said Seph Jensen, TearLab’s Chief Executive Officer. “We believe we can address the comments raised in the FDA’s letter and plan to submit our response within the allowed 180 day timeframe. We remain on track to have a clearance decision sometime in the second half of 2018.”
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 OTCQB Market under the symbol 'TEAR'.
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, the potential success of the development agreement in progressing successfully or resulting in a successful commercial product, the willingness of either party to fund and continue the development agreement, the probability of the development agreement leading to a future supply agreement and whether the development agreement might lead to additional opportunities in other fields. 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 Reports on Form 10-Q for the quarter ended September 30, 2017, filed with the SEC on November 13, 2017. We do not undertake to update any forward-looking statements except as required by law.
The Ruth Group