TEL AVIV, Israel, January 7, 2016 /PRNewswire/ --
BioLight Israeli Life Sciences Investments Ltd. (TASE: BOLT, OTCQX: BLGTY) ("BioLight" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today the completion of a successful U.S. clinical study that was designed to assess the effectiveness of its TeaRx™ multi-assay test in evaluating tears' components of healthy subjects as well as of patients suffering from dry eye syndrome ("DES").
This prospective study, conducted by Ora, Inc. ("Ora") enrolled 74 subjects in the U.S. All study subjects were evaluated using a composite of four established benchmark tests for the assessment of DES, used in previous U.S. Food and Drug Administration ("FDA") regulatory approval processes for other DES products, to define and distinguish populations of healthy subjects from those with different grades of DES. Study subjects were also evaluated using TeaRx™'s assays. The selected combination of TeaRx™'s assays and the subjects' demographics data were used to build predictive statistical model as a mean to determine the combination assays which provides the best TeaRx™ multi-assay test diagnostic power.
Study results demonstrated sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 87% for the TeaRx™ multi-assay test. The study results also demonstrated that the TeaRx™ multi-assay testing approach, which incorporates a combination of tear constituents originating from different locations in the eye, has the ability to provide a more robust diagnostic output than other already marketed DES tests.
Suzana Nahum Zilberberg, BioLight's CEO, commented, "We are very excited about the results of this second U.S. clinical trial. TeaRx™ allows for an in-office, multi-assay testing process which, for the first time, has the potential of going beyond the binary diagnosis of DES by also identifying sub-populations among those who suffer from the syndrome. We also believe that this will make us an attractive collaboration partner for pharmaceutical companies working to advance new DES therapies, steering clinical development end-points away from subjective signs and symptoms toward objective measurements. TeaRx™ also has the potential of becoming a valuable companion diagnosis tool to assist physicians in customizing treatment for DES patients. To those ends, these trial results will be used as a basis for discussion with global regulatory authorities, including the FDA, regarding the product approval process for this important test."
George Ousler, Ora Inc. Vice President, Dry Eye said: "It is encouraging that the TeaRx™ has shown in a confirmatory study that it can accurately diagnose dry eye patients with a high correlation between the TeaRx™ assays and existing tests for this syndrome as used by the FDA. Dry eye is a complex, multi-factorial disease and a technology like the TeaRx™ has the potential to improve our ability to diagnose and differentiate between its various underlying etiologies. A multi-assay approach should facilitate tailored treatment modalities as additional and more targeted therapies become available."
About Dry Eye Syndrome
DES is a chronic, progressive disorder of the ocular surface in which the eye produces insufficient tears or tears with abnormal composition. In its mild to moderate forms, DES may cause pain and discomfort and can impact vision quality. In its most severe forms, DES can lead to permanent vision loss. DES affects approximately 100 million people worldwide, approximately 20 to 40 million of whom are in the United States, and it is estimated that dry eye-related symptoms account for one third of all visits to eye doctors in the United States.
The TeaRx™ multi-assay test provides a simple, rapid, semi-quantitative and objective analysis of tear film constituents in order to diagnose DES and identify one or more of its underlying causes. BioLight believes TeaRx™ has the potential to be both a clinically valuable point-of-care test as well as a companion diagnostic test that addresses the need for rapid testing and personalized medicine. Once its commercial development is complete, the Company expects TeaRx™ multi-assay test to be a cost-effective, easy-to-use and objective solution that will allow eye-care professionals to diagnose and treat patients who suffer from symptoms of DES, including those who may otherwise be undiagnosed or unidentified.
BioLight address ophthalmic significant unmet medical needs with a pipeline of products and product candidates, which are in various commercial and clinical stages, including: IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a diagnostic solution that provides a multi-assay analysis of tear film constituents in order to identify one or more underlying causes of DES; Eye-D™, an in-office insertable platform that provides for controlled release of ophthalmic medications over time and OphRx's lyotropic liquid crystals, or LLC, a non-invasive drug delivery technology administered through eye drops as an alternative to current ocular delivery modalities. BioLight has also invested, through Micromedic, in innovations in cancer diagnostics, including proprietary tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel and Rock-One, a Hong Kong-based investment company.
For more information please visit the Company's website at http://www.bio-light.co.il.
Itai Bar-Natan, CFO
SOURCE BioLight Israeli Life Sciences Investments Ltd.