Medical Devices

Medical device dry-eye treatment LipiFlow wins FDA approval

A medical device dry-eye treatment that wants to replace eye drops has received U.S. Food and Drug Administration approval.

North Carolina’s TearScience has won FDA approval for its LipiFlow Thermal Pulsation device, which can eliminate gland blockages that in many cases keep the eye from being properly lubricated.

A limited number of the LipiFlow medical devices, which are already being sold in Europe and Canada, will be available immediately in the United States through the end of 2011. In the meantime, TearScience will hire a number of sales and customer service positions over the next year as it ramps up production, said Tim Willis, TearScience’s co-founder and CEO.

Approximately 30 million to 40 million people in the United States deal with dry eye disease, and it is one of the most common reasons people see an eye doctor, according to CBDM.T’s 2010 report on the dry eye market. CBDM.T estimated the dry-eye market could be worth at $2.4 billion by 2014.


TearScience’s product focuses on the roughly 65 percent of patients whose problems are caused by meibomian gland dysfunction, in which glands in the eye fail to produce or secrete lipids that keep the tear film lubricated, producing dry eye symptoms such as itching, aching and blurred vision.

Lipiflow is a single-use eyepiece that warms and massages the eyelids, melts the obstructive material clogging the glands and clears the blockage without damage to glands or other delicate structures of the eye. It’s a 12-minute per eye procedure performed in a doctor’s office.

A counterpart to the device called the LipiView Ocular Surface Interferometer, which evaluates the tear film to see if it contains enough lipids, has already been approved for use.

Eye drops are usually the first-line treatment, according to the CBDM.T report. But more than 15 new products were under development in 2010 for dry-eye treatment, the report stated.

“It’s good timing for us – and it was planned that way,” said Willis, who said he’s been involved in at least five startup companies and has helped launch at least 50 ophthalmology products.

TearScience has promoted its product as a life-changer for patients: the end of accommodations such as constant eye drops or limiting computer time, for example. But it’s unclear how much the one-time cost of the product will impact the number of patients who will be able to use it. Some estimates have the dry-eye treatment costing about $100,000 and it is not yet reimbursed through insurance.

TearScience has raised more than $70 million, including $44 million in May 2010. Its investors include Essex Woodlands Health Ventures, Investor Growth Capital, General Catalyst, De Novo Ventures, Spray Ventures and Quaker Bio Ventures.

Willis said he does not know whether the company will need to do another round of fundraising to accommodate for the next step.

TearScience will announce its approval in a press conference Monday morning.

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