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FDA: Aye-Aye to 2nd TearScience Dry-Eye Tool


LipiFlow clears lubricating glands beneath eyelid  

TearScience is on a tear.

In October 2011, the 6-year-old privately held Morrisville medical device company announced a $15 million venture debt deal with Oxford Finance and Silicon Valley Bank. 

That was on top of a year-earlier $44.5 million in award-winning Series C funding.

Now the company has received clearance from the United States Food and Drug Administration for its second-generation LipiFlow medical device, on the heels of its first-generation device approval only months earlier. 

LipiFlow is used by ophthalmologists to treat patients with an annoying condition called evaporative dry eye. The treatment addresses the root cause of dry eye, obstructed glands in the eyelid. It helps clear out these obstructed meibomian glands so they can resume their natural secretion of lipids (oils) required to keep tears from evaporating too quickly.

 The treatment, performed at eye-care clinics in 12 minutes, is a breakthrough alternative to traditional dry-eye therapies such as so-called “wetting” drops, ointments, lid scrubs and warm compresses.

LipiFlow Dry-Eye Treatment Device

This second-generation LipiFlow has an enhanced graphical user interface and allows physicians to treat both of a patient’s eyes simultaneously. It will be commercially available in March 2012, and clinics using the original device will  be upgraded to the new version.

TearScience won a 2010 fund-raising award from Southeast BIO (SEBIO), a nonprofit organization that fosters the growth of the life sciences industry in the U.S. Southeastern region.

That Southeast Deal of the Year Venture Capital Transaction Award recognized the firm’s $44.5 million in Series C funding in May 2010. It was the largest med tech venture capital funding in North Carolina and in the Southeast in 2010, according to Cindy Clark, president of ibiliti, the Center of Innovation for North Carolina’s advanced medical technologies industry, started by the North Carolina Biotechnology Center.

TearScience’s C round investors included Essex Woodlands Health Ventures, Investor Growth Capital, General Catalyst, De Novo Ventures, Spray Ventures and Quaker BioVentures, all from outside North Carolina.