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the clinical trial, such as burning sensations and broken blood vessels, were reported in four patients treated with iLux, though they were temporary.
Early signs of dry eye disease appear to be growing in children, according to a small Duke University study published in the April issue of the journal Cornea. The study evaluated 99 children who had no history of dry eye. Of those, 42 percent showed signs of deteriorating meibomian glands. The researchers say the findings suggest that diminished function of these eye glands might be more common than first thought, and could be found in people who show no symptoms.
The Duke study says dysfunctioning meibomian glands, along with factors such as extensive viewing of digital screens, could lead to a higher risk of dry eye problems. But the study’s authors also note that the assessment was a snapshot in time; eye glands must be studied over long periods to understand how they change over the course of a patient’s life.
The Duke scientists also pointed to a study in South Korea, where smartphone use by 90 percent of people ranks among the highest in the world. That research, published last year in BMC Ophthalmology, found that of the 916 children in the study, 60 had dry eye disease. Those children, on average, used smartphones more each day and spent less time outdoors than children who did not have dry eye. After children in the dry eye group stopped using smartphones for four weeks, symptoms improved, according to the published results. The report says it’s possible that smartphone use could lead to less blinking, which may contribute to or cause dry eye disease in children.
Galor, the ophthalmologist, says blinking is key to eye health because it replenishes the tear film and spreads it evenly across the eye. But even though people tend to blink less when they use digital devices, she adds that the current medical thinking is that environmental conditions and not digital devices are causing dry eyes. Those conditions include rooms that have low humidity, fans blowing in the face, or allergies. When meibomian gland dysfunction is diagnosed, Galor says low-tech treatments include using a warm, wet washcloth to scrub the eyelids and clear debris blocking the glands.
Though the published studies don’t conclusively link smartphone use to dry eye, Thornhill sees prevalence of the condition as a byproduct of digital screen viewing. And he envisions his company’s medical device treating patients globally. Last month, Tear Film received regulatory clearance in Canada, where the company plans to sell iLux through a partner. The company has also applied for authorization to sell it in Europe, where Thornhill hopes to launch by the end of the year.
The cost of treatment with Tear Film’s device will be up to each physician, but Thornhill says the price—to both patients and physicians, who must buy the device—will be approximately half of LipiFlow’s price. Patients can now find LipiFlow treatment for $500 to $700 per eye, which is less than half of what the treatment cost when TearScience first launched its product. Insurance companies do not reimburse for treatment with either medical device. Thornhill says he might talk to insurance companies about covering the treatment, but he adds that for now, physicians have told Tear Film that they are satisfied with patients paying directly.
Investors have poured $18.5 million into Tear Film. The most recent financing, an $8.5 million Series B round of funding, closed last month led by Visionary Ventures Fund and Bluestem Capital. Thornhill says the company will use the cash to beef up its sales and marketing staff for a near-term commercialization push. In the long term, he says his startup will develop new capabilities for iLux, as well as new dry eye treatments.
“Dry eye is our single focus,” he says.