Devices & Diagnostics

How TearScience’s dry eye treatment sparked a new FDA 510(k) strategy

The dry eye treatment developed by TearScience received 510(k) clearance last week, about seven months after the company’s novel medical device received its first marketing go-ahead from the U.S. Food and Drug Administration. While the speed at which regulators granted the second 510(k) clearance surprised TearScience CEO Tim Willis, he says the sequential filings were […]

The dry eye treatment developed by TearScience received 510(k) clearance last week, about seven months after the company’s novel medical device received its first marketing go-ahead from the U.S. Food and Drug Administration.

While the speed at which regulators granted the second 510(k) clearance surprised TearScience CEO Tim Willis, he says the sequential filings were by design.

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“If you tried to do both of these filings (at once), especially in this regulatory environment, I doubt we’d get cleared by now,” he said.

An estimated 100 million people worldwide have dry eyes, many of them suffering from evaporative dry eye. Evaporative dry eye is caused by insufficient supply of the oils that keep the tear film from evaporating. Dry eye symptoms can be managed with drugs or eye drops, but Morrisville, North Carolina-based TearScience has developed and commercialized a medical device to treat the condition’s underlying cause. The device, LipiFlow, uses a combination of heat and pressure to clear the channels that supply oils to the tear film. According to research firm Market Scope, the dry eye market is a $2.2 billion a year business*. By comparison, Lasik eye surgery represents a $700 million market.

Willis said that had TearScience been in a position to apply for FDA clearance on its technology 10 years  ago, the company would have submitted everything in one filing — all 7,000 pages of it. But Willis said that the current FDA is risk averse, which slows review of new devices. In hopes of speeding things along, the company made an initial filing for the part of LipiFlow that treats the patient — the disposable piece that is used on the patient’s eye. After that part received FDA clearance, the company filed its application for what the physician uses including upgraded software and a handheld unit. It’s the full unit that TearScience will be marketing in the United States.

The two separate filings may have sparked what could become a new regulatory strategy for other medical device developers. Willis said that one of the firm’s investors told him that he was so impressed with the relative speed of an FDA decision from the two filings that the investor will now press its other companies to pursue the same strategy.

One piece of the commercialization puzzle that TearScience has yet to solve is reimbursement. Insurers do not yet pay for LipiFlow treatment and though the company has applied to instate reimbursement, Willis estimates the entire process can take anywhere from three to 10 years. For now, patients pay between $1,400 and $1,900 out of pocket for a treatment on both eyes that lasts nine to 18 months. Willis said that considering that some people with moderate to severe dry eye are already spending up to $4,000 annually on other remedies, patients are willing to pay. For a physician’s practice, the entire TearScience diagnostic and treatment system costs about $100,0000.

The new system will become available to U.S. doctors in March. It’s the same system that became available last year in Canada, Europe and Asia. The United States is the only market where TearScience made two separate LipiFlow regulatory filings for marketing clearance. Willis said in 2012 TearScience will seek clearance in as many as 20 new countries worldwide.
* This figure was reported incorrectly when the article was first published.

Photo from Flickr user orangeacid