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    Dry eye diagnostic shows early promise, points to influential factors


    Nimrod Bin-Nun, CEO of BioLight’s portfolio company, DiagnosTear, was more direct in his assessment of current generation dry eye diagnostics.

    “It is naïve to think that one test can diagnose or that one drug can treat the multiple factors that lie behind dry eye syndrome,” he said. “The only way to diagnose a multi-factorial syndrome like dry eye is by using multiple assays. We have developed several assays that measure concentrations of different proteins, different inflammatory factors and other substances in the tear film taken from different locations in the eye. Measuring a combination of components relating to different physiological pathways can contribute significantly to both diagnosing these patients and personalizing their treatment.”

    The company has not disclosed which substances or parameters it is measuring in tear film. What researchers are willing to say is that a model combing multiple tear film components and demographics produced a sensitivity of 86% and a positive predictive value of 87% for dry eye.

    These results are better than those typically seen in existing office-based testing systems, including Schirmer’s Test, tear film break-up time, corneal staining, symptomatic questionnaires and are well positioned versus other commercialized diagnostic tests such as RPS InflammaDry and TearLab.

    Timing of the trial could be helpful, Dr. Ousler said. There is currently only one drug indicated for the treatment of dry eye in the United States—cyclosporine, an anti-inflammatory—but there are multiple agents in development, including other anti-inflammatories, secretagogues, hormonal therapies, and more. Appropriate patient selection for each of these drug candidates is a potential barrier for both successful clinical trials and effective treatment.

    “Because there are so many treatment modalities that will be coming to the market relatively soon, we are going to have to have some clarity as to which drug is most appropriate for each dry eye subtype,” he said. “We are going to want to be able to match the patient to the medication that is most appropriate based on the underlying mechanism of action for that specific drug. If I have a novel mucin secretagogue, I am going to want to have a test to say ‘Yes, this patient has a mucin-deficient dry eye’ rather than an inflammatory dry eye. Having a test like this to use as a differential diagnosis to select your treatment modality of choice would be a benefit.”

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