Business

Morrisville company gets clearance to sell dry eye product

Posted July 11, 2011

— 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."

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  • JustOneGodLessThanU Jul 12, 12:01 p.m.

    @nighttrain, have you been to Asia or China? I have. They have the anything-goes system of which you speak. You'll love it! It's Caveat Emptor on steriods. No pesky regulations. No pesky rules. Not even food labels! It's an anarchist's (Tea Partier's?) dream. What are you waiting for? Just look at what you're missing!

    Personally, though, I like safe food & drugs, clean water & air, etc. YMMV

  • nighttrain2010 Jul 11, 5:04 p.m.

    >>your simplistic view of the corporate world and of consumerism is actually dangerous in it's profound lack of understanding

    LOL, my simplistic view. Because I don't accept the 'love' government has for me (even though it's FDA approved drugs that have killed people something the FDA is there to supposedly 'prevent') I have a dangerous view and a 'lack of understanding'.

    >>You think the drug companies market drugs to help people? You are more than naive.

    Never stated that did I? They're in it for profit which I FULLY support

    >>Do you think for ONE MINUTE that they value human life above profits?

    Frankly I don't really care. That's their business and the business of the consumers that use those products

    >>and if a drug does not harm enough people to reach the threshold of sales vs lawsuits, it's gonna be on the market.

    Fully approved by the FDA which apparently we need...and I'm the one with the simplistic view.

  • bigal02282 Jul 11, 3:37 p.m.

    @nighttrain2010.. your simplistic view of the corporate world and of consumerism is actually dangerous in it's profound lack of understanding. For every drug that made it through, there were hundreds that didn't make it due to bad science or research. Would you have drugs TESTED on the PUBLIC to determine their effectiveness or usefulness? The drugs that you mentioned that were approved were approved using data submitted BY THE COMPANIES themselves and/or from research partially or wholly funded by them in many instances. You think the drug companies market drugs to help people? You are more than naive. They do so because by filling a need, they PROFIT. Drug companies are the THIRD MOST PROFITABLE industry in the WORLD. Do you think for ONE MINUTE that they value human life above profits? They have figured out EXACTLY what a human life is worth to them, and if a drug does not harm enough people to reach the threshold of sales vs lawsuits, it's gonna be on the market.

  • Raleigh Boys Jul 11, 2:35 p.m.

    This is great news for people who had a bad experience from lasik. Perhaps this will relieve dry eye symptoms for patients that got a bad surgery, in Durham off Roxboro Road.

  • nighttrain2010 Jul 11, 2:17 p.m.

    >>And, don't some people want to disband the FDA?

    For every 'great' drug come other 'great' drugs like Chantrix (also approved by the 'wonderful' FDA). I would rather the market decide what drugs go and don't go (with a simple warning of side effects provided by the manufacturer) and I'll make my own decisions on what goes into my body thank you very much.

    It's called personal responsibility.

    >>I'm thrilled that there's a governing body that requires proof of a product's safety and efficacy

    Yep it's done so well hasn't it? It's provided grown adults from partaking of some of the wonderful foods around the world, given us drugs that have to be recalled later, and created a level of bureaucracy unseen in history. Thanks government!!!

  • JustOneGodLessThanU Jul 11, 1:07 p.m.

    And, don't some people want to disband the FDA?

    This is awesome work and with it, comes awesome responsibility. I'm thrilled that there's a governing body that requires proof of a product's safety and efficacy. On the other hand, some people don't care what they put into their or their children's bodies. YMMV