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    Dry eye diagnostic shows early promise, points to influential factors

     

    BioLight is looking at TeaRx as more than a quick and easy point-of-care diagnostic. It would also like to see the test, or a later version, designated as a companion diagnostic for novel therapeutic agents. The diagnostic first needs marketing approval in the United States and other jurisdictions.

    BioLight has conducted all of its early U.S. clinical trials to support its path with the FDA which, based on previous approvals, is anticipated to be under the 510(k) pathway. Mr. Bin-Nun noted that the TeaRx trial used the same standardized grading scale for dry eye severity that was used for the approval of the InflammaDry.

    Diagnostic test trials can be relatively quick to design and execute; the first TeaRx trial with about 200 patients was completed in less than two months.

    “We are planning a pre-submission to the FDA in the near future, aiming to establish the regulatory pathway,” said Ms. Zilberberg. “Once we understand the pathway we need to follow, we will initiate the appropriate clinical trials. Based on the trials we have conducted in the United States so far, we don’t think it will be a long process, which would be a great benefit for early approval and early clinical use.”

     

    George Ousler, MD, Director of dry eye research for Ora

    E: [email protected],

     

    Suazana Nahum Zilbergerg, CEO of BioLight

    E: [email protected]

     972-73-2753400

     

    Nimrod Bin-Nun, CEO of DiagnosTear

    E: [email protected]

    972-73-2753419

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