TEL AVIV, Israel—BioLight Life Sciences Investments Ltd. has announced that DiagnosTear Ltd., one of the companies in its XLVision Sciences ophthalmology cluster, has received all necessary approvals from Sheba Medical Center to begin a clinical study of TeaRx, a point-of-care dry eye syndrome diagnostic assay. The clinical study will seek to validate the effectiveness of the test methods DiagnosTear has developed in the tears of patients with dry eye syndrome, as well as in healthy subjects.
DiagnosTear intends to add another Israel-based center to the study soon, and expects to have results to report in the fourth quarter of this year.
The TeaRx assay is based on a variety of reagents that cause color reactions when they come into contact with the tear film, thus enabling semi-quantitative determination of the parameters that define dry eye syndrome. Information on those parameters assists ophthalmologists in diagnosing dry eye syndrome and better determining the best way to monitor and treat the affected individual.
“The beginning of the DiagnosTear clinical study is an additional development milestone in one of the most promising projects in our XLVision Sciences cluster,” Suzana Nahum-Zilberberg, CEO of BioLight, said in a press release. “About 100 million people worldwide suffer from dry eye syndrome, and many more suffer from similar symptoms. A significant improvement in the diagnosis of the syndrome is needed, and DiagnosTear provides a very promising assay that assists physicians in diagnosing the syndrome, selecting the right treatments and monitoring progress.
“A market analysis performed among U.S. ophthalmologists shows that the assay DiagnosTear develops as a multi-parameter, cost-effective and easy-to-use solution is designed to meet those needs,” she continued. “This clinical study … is another significant step in the development process. We note that this diagnostic assay has stimulated strong interest among leading ophthalmic companies and key opinion leaders worldwide.”
Dry eye syndrome, also known as keratoconunctivitis sicca, is mainly the result of changes in the composition of tears, or a reduction in the amount of tears the eye secrets. It can be a chronic condition, and cause a great deal of discomfort, though it can generally be adequately addressed with eye drops. Market Scope, an ophthalmic market research firm, estimates that there are approximately 100 million people worldwide who suffer from dry eye syndrome to varying degrees, with some 25 million to 30 million of those people in the United States. Worldwide, the dry eye syndrome market stands at about $3 billion.
There is little competition in terms of alternative diagnostics for this condition, according to DiagnosTear’s website. One method is Schirmer’s test, which determines whether a patient’s eye is capable of producing enough tears to keep it moist (tear volume parameter) by placing small strips of special paper inside the lower eyelid of each eye, closing the eyes, then measuring how moist it is after five minutes. Another test is the TearLab Osmolarity Test, which determines the composition of tears.
BioLight’s work involves investing, managing and commercializing biomedical innovations that are grouped into “clusters” related to medical conditions. The firm’s two clusters include ophthalmology, thanks to its sole ownership of XLVision Sciences—which in turn owns 70 percent of DiagnosTear—and cancer diagnostics. BioLight issued a press release in October 2013 that DiagnosTear had announced that it had received approval for a grant from the Office of the Chief Scientist to develop a dry eye syndrome diagnostic. The press release noted that “According to the approval, the participation will be at a scope of 40 percent of a NIS 1,693,590 budget. Royalties shall be paid out of the revenues of DiagnosTear from sales of a diagnostic kit for the dry eye syndrome, if any, as detailed in the approval.”