FDA clears TearScience's LipiFlow Thermal Pulsation System to treat dry eye

TearScience, Inc.Feb 1 2012

TearScience, Inc., a privately-held medical device company, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its next generation product of its LipiFlow^® Thermal Pulsation System, a medical device that treats evaporative dry eye by liquefying and evacuating obstructions in meibomian glands located in the eyelids. The second generation product includes a more robust graphical user interface and provides the ability for physicians to treat both of a patient's eyes simultaneously.

The new LipiFlow^® console incorporates an enhanced graphical user interface by controlling pressure and displaying the treatment temperature, pressure sequence and treatment time remaining. The new LipiFlow^® also allows physicians to store a record of the treatment on the device and on electronic medical record servers, eliminating the need to manually document the treatment in patient records. LipiFlow^®'s second generation product also allows physicians to treat two eyes simultaneously. Time savings achieved by performing a bilateral treatment is beneficial for both busy physicians and patients alike.

"We are pleased to have received FDA clearance for the second generation LipiFlow^® to offer to our current and future customers," said Tim Willis, chief executive officer and co-founder of TearScience. "The improvements in this next generation LipiFlow^® reflect TearScience's commitment to innovation. TearScience expects to provide many more enhancements that will assist physicians in treating dry eye sufferers efficiently, effectively and profitably."

TearScience's second generation LipiFlow^® product will be commercially available in March 2012. Physicians currently using TearScience's first generation LipiFlow^® will be upgraded to the new system.

TearScience sells its LipiFlow^® and LipiView^® Ocular Surface Interferometer devices as a system for eye care practices. The LipiView^® enables physicians to visualize the eye's tear film. LipiView^® won the 2011 Medical Design Excellence Award.