Morrisville, N.C. — A Morrisville-based company has gotten clearance from the U.S. Food and Drug Administration to market and sell a technology used to help people with dry eyes.
TearScience announced Monday that it has received FDA clearance for its LipiFlow Thermal Pulsation System, which is designed for the treatment of meibomian gland dysfunction (MGD), also known as evaporative dry eye.
The clearance enables the privately-held medical device company to market and sell the system 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. MGD may well be the leading cause of dry eye disease throughout the world.
“At last, physicians will have the necessary tools they need to break the cycle of frustration for many dry eye patients,” said Dr. Alan Carlson, chief of the corneal, external disease, and refractive surgery service at the Duke Eye Center in Durham. “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.
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 FDA has approved 20 new drugs so far this year, just one short of the total for all of 2010, according to a top agency official last week. The pace likely puts the FDA on track to approve more new types of drugs in 2011 than the previous few years.
TearScience’s technology, however, does not fall into this list.
FDA's drug approval figures released on Thursday involve only drugs or biologics – which are made from living cells – that are considered new types of products. They don't include approvals granted for new formulations, systems, or new uses of existing drugs as well as vaccines.
“The LipiFlow system is a very unique, very exciting system,” said Dr. Stephen Lane, of Associated Eye Care of Stillwater, Minn.
TearScience will sell its LipiFlow and LipiView Ocular Surface Interferometer devices as a system for eye care practices.
Tim Willis, chief executive officer and co-founder of TearScience, said Monday marks an important day for ophthalmologists in the U.S.
“This is a paradigm shift in addressing the root cause of the disease and not just the symptoms,” Willis said. “Today, the patients win."