BioLight dry eye subsidiary approaching CE Mark filing, U.S. pivotal trial
DiagnosTear, the dry eye diagnostic subsidiary of BioLight Life Sciences (TASE:BOLT), hopes to file by the end of 2017 for CE Mark approval in Europe and begin a pivotal trial in the U.S. in mid-2018 with its TeaRx device to aid in the diagnosis and monitoring of dry eye syndrome (DES).
“Currently, we are developing two product lines for TeaRx: a point-of-care diagnostic of tear film for the physician’s office and a companion diagnostic for pharmaceutical companies to identify responders to a specific therapy and the therapy’s mode of action,” Suzana Nahum Zilberberg, chairperson of DiagnosTear, says in an interview with BioTuesdays.
Ms. Zilberberg also is CEO of BioLight, which owns more than 80% of DiagnosTear.
DES is a common disorder of the ocular surface in which the eye produces insufficient tears or tears with abnormal composition. In its mild-to-moderate forms, DES causes pain and discomfort, can impact vision quality and the ability to go about daily activities.
According to Ms. Zilberberg, more than 350 million people worldwide are affected by DES, one of the leading causes of patients’ visits to eye care practitioners in the U.S. “So, there is strong demand for better patient diagnosis, and companion diagnostic solutions to determine which patients will respond to the potential of personalized treatment,” she adds.
Current diagnostic devices measure only one biomarker. “We took a different approach and developed a device to measure different biomarkers related to different elements of dry eye to identify not only if a patient has dry eye but also the underlying cause of the disease,” Ms. Zilberberg points out. “This is intended to improve patient outcomes.”
She contends that dry eye is a complex, multi-factorial disease and a technology like TeaRx has the potential to improve the diagnosis and differentiation between its various underlying causes. “A multi-assay approach should facilitate tailored treatment modalities as additional and more targeted therapies become available.”
The FDA to date has approved only two drugs for DES. “When we look at the dry eye landscape over the next two-to-three years, we see many compounds in development, which we believe will make TeaRx very relevant to pharmaceutical companies trying to get to the market and also to physicians looking for optimizing patients’ treatment,” she adds.
Ms. Zilberberg indicates that in an original clinical trial with 200 DES patients in the U.S., TeaRx demonstrated a strong correlation with widely used benchmark tests now being used. A follow-up study with 74 patients showed a 86% sensitivity and 87% specificity, which is “very high compared with what is in the market place now,” she says, in distinguishing between DES patients and healthy subjects.
At the end of August, DiagnosTear began an additional clinical trial at two medical centers in the U.S. with 41 healthy and 41 DES subjects to ensure the repeatability of positive findings from two earlier studies. Final statistical results are expected before the end of 2017. The study will expand the clinical database prior to submitting TeaRx for marketing approval as a hand held point-of-care device in Europe.
Ms. Zilberberg says the company also has submitted a pre-investigational device exemption with the FDA for a pivotal trial to begin in mid-2018. “The trial will take only several months to complete and, if successful, would allow us to file for regulatory approval by the end of 2018,” she adds.
Regarding development of TeaRx as a companion diagnostic, Ms. Zilberberg contends that DiagnosTear has developed a set of objective biomarkers, which represent different aspects of dry eye and can differentiate between responders and non-responders to a specific treatment. “This can offer drug developers the potential of successful clinical trials and a commercial differentiation.”
These companies are facing major challenges: the first is patient selection to their trials and the second is setting the right endpoints for the trail, Ms. Zilberberg points out.
TeaRx also can support identifying the sub-populations of responders and non responders to a specific therapy, and understanding the mode of action by comparing findings from patients’ tear film compositions at the end of the trial against visit one, she adds. “This has the potential of a commercial collaboration following approval of a new therapeutic.”
DiagnosTear previously has added TeaRx as a companion diagnostic in a drug company’s Phase 3 clinical trial for a DES drug and is at different stages of collaborating with pharmaceutical and medical device companies that treat DES.
“As we saw at the recent meeting of the American Academy of Ophthalmology, the DES sector is very active and the medical need is understandable,” she adds.