Dry eye treatment from TearScience gets FDA 510(k) clearance

Medical device company TearScience has received 510(k) clearance on the latest version of its evaporative dry eye treatment.

The Morrisville, North Carolina company’s novel dry eye treatment initially received U.S. Food and Drug Administration clearance last summer. The company’s LipiFlow device works by clearing the channels that supply the eye with the oily film that keeps the tear film from evaporating, leading to dry eyes. Dry eye has traditionally been treated with eye drops to address dryness symptoms or to reduce inflammation.

TearScience’s eye treatment is administered in a doctor’s office. Enhancements to the latest version of the medical device include the ability to now treat both of a patient’s eyes simultaneously. An estimated 100 million people worldwide suffer from dry eyes, the majority of them suffering from evaporative dry eye.

Privately held TearScience, founded in 2005, has raised more than $70 million in venture capital financing from Essex Woodlands Health Ventures, Investor Growth Capital, General Catalyst, De Novo Ventures, Spray Ventures and Quaker Partners. Last fall, TearScience secured $15 million in venture debt financing to support commercialization efforts.

TearScience’s technology consists of two components. While LipiFlow administers the dry eye treatment to patients, the LipiView system allows physicians to view the tear film to make an evaporative dry eye diagnosis. LipiView received FDA clearance in 2009. TearScience already has marketing approval for the technologies in Europe.

Photo from TearScience