TearScience, Inc., a privately-held medical device company, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its LipiFlow® Thermal Pulsation System for the treatment of meibomian gland dysfunction (MGD), also known as evaporative dry eye. The clearance enables TearScience to market and sell LipiFlow® to eye care physicians in the U.S. LipiFlow® will be available immediately, but on a limited basis in the U.S. through the end of 2011. LipiFlow® removes meibomian gland obstructions by applying directed energy to a patient's eyelid during a 12-minute in-office treatment.
“Now, with FDA clearance to market the LipiFlow®, TearScience provides a new, innovative alternative treatment that delivers effective relief for many patients who desperately need it.”
As stated in the workshop report dated March, 2011 from Tear Film and Ocular Surface Society's (TFOS) two-year international workshop on MGD, MGD may well be the leading cause of dry eye disease throughout the world. MGD's role in ocular health is gaining recognition as the industry reaches consensus on a standard definition, classification, diagnosis, and therapy for the disease.
"At last physicians will have the necessary tools they need to break the cycle of frustration for many dry eye patients," said Dr. Alan N. Carlson, chief of the Corneal, External Disease, and Refractive Surgery Service at the Duke Eye Center in Durham, N.C. "Now, with FDA clearance to market the LipiFlow®, TearScience provides a new, innovative alternative treatment that delivers effective relief for many patients who desperately need it."
Of the more than 100 million dry eye sufferers worldwide, approximately 65 percent have evaporative dry eye. Common symptoms of the disease include eye irritation, dryness, redness, tiredness, and visual disturbances. TearScience's integrated, in-office system addresses a root cause of evaporative dry eye, the obstructed glands. By assessing the tear film and meibomian gland function, physicians can determine whether MGD is the primary cause of a patient's evaporative dry eye and whether a patient is a good candidate for the LipiFlow® treatment.
TearScience gained FDA clearance by demonstrating the safety and effectiveness of LipiFlow® through a U.S.-based nine-center randomized controlled clinical trial for the treatment of evaporative dry eye.
"The LipiFlow® system is a very unique, very exciting system," said Stephen S. Lane, MD of Associated Eye Care of Stillwater, Minnesota. "For the first time, we have a dry eye treatment regimen that patients can undergo in 12 minutes per eye in a physician's office. When LipiFlow® patients were seen for follow up appointments, they were very excited about the significant decrease in symptoms with many noting a significant improvement in the comfort level they were having - even from the first day of the procedure."
TearScience will sell 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.
"We are gratified and blessed to have secured FDA clearance for the LipiFlow®," said Tim Willis, chief executive officer and co-founder of TearScience. "This marks an important day for ophthalmologists as now our advanced technology is available for their dry eye patients. I'm grateful to all those who have helped us reach this important milestone, especially our employees, our venture capital partners, the many physicians and patients involved in our development efforts and clinical trials and particularly, Dr. Donald Korb, the genius behind our technology."