TearScience Receives FDA Clearance for Dry Eye Treatment

CED Member TearScience®, Inc., a privately-held medical device company, today announced that the U.S. Food and Drug Administration (FDA) has cleared additional features and broadened the indication for use of the company’s LipiView® Ocular Surface Interferometer. TearScience® can now claim LipiView® measures the absolute thickness of the tear film lipid layer in nanometers.  LipiView®’s broadened indication for use is a result of the U.S. FDA clearing LipiView®’ssecond generation software.  LipiView® v2.0 software will be available to all new customers with current customers to be upgraded by the second quarter of 2013.

Physicians can use LipiView® as part of a full dry eye assessment to determine the type of dry eye a patient has by identifying lipid layer deficiency, the most common cause of dry eye.  The upgraded LipiView® software also acquires a patient’s blinking process during examination providing physicians with the ability to identify patients who are partial blinkers, a condition that may limit lipid production and impact the ocular surface.  

“Improvements in imaging technology have helped advance almost every aspect of medicine,” said Alan N. Carlson, MD, chief of the Corneal, External Disease, and Refractive Surgery Services at Duke Eye Center in Durham, North Carolina.  “Now, with LipiView®, we have nanometer precision in measuring that critical lipid layer of the tear film, which is recognized as the culprit in the most common cause of dry eyes.  LipiView® helps with assessing for dry eye, developing a treatment strategy, and monitoring a patient’s progress.  LipiView® also is an invaluable tool in educating the patient visually for a much greater understanding of the disease process.”

“We are pleased to receive U.S. FDA 510K clearance on LipiView®’s expanded indication for use,” said Steve Grenon, vice president of research and development for TearScience®.  “Our goal is to help physicians improve dry eye patient care  by identifying evaporative dry eye and guiding patients to the best treatment and therapies for this highly prevalent, chronic, and progressive disease1.  Physicians can expect continued innovations from TearScience®.  We will continue to deliver enhancements to make LipiView® the most powerful tool for physician dry eye evaluations and patient education.”

More than 23 million Americans suffer from dry eye disease.  With 86 percent of all dry eye sufferers having evaporative dry eye, it represents a more than $10 billion market potential in North America. TearScience® has developed and launched a system to address this market. The system includes two medical devices, the LipiView® Ocular Surface Interferometer and the LipiFlow® Thermal Pulsation System.  Evaporative dry eye occurs when Meibomian glands in the eyelids become obstructed and do not secrete the oily lipids needed to keep the water portion of tears from evaporating too quickly.  LipiView® measures the absolute thickness of the lipid layer of a dry eye patient’s tear film while LipiFlow® treats a root cause of evaporative dry eye disease by unblocking obstructed Meibomian glands located in the eyelids during an in-office procedure.  The goal of unblocking the Meibomian glands is to allow them to resume their natural production of lipids required for a healthy tear film.