MORRISVILLE, N.C., Aug. 23, 2016 /PRNewswire/ -- TearScience, a privately held medical device company and manufacturer of LipiFlow® for treatment of meibomian gland dysfunction (MGD), announced the publication1 of a seminal prospective, multicenter clinical trial showing that a single LipiFlow treatment can deliver sustained mean improvement in meibomian gland function and Dry Eye symptoms through 12 months. The study also concluded that early LipiFlow intervention for meibomian gland dysfunction is associated with improved treatment outcomes.
MGD is the most common cause of Dry Eye. It is prevalent, progressive and obstructive. For most patients, successful treatment of MGD requires removal of obstruction.
The mean improvement of meibomian gland function and Dry Eye symptoms have been frequently studied, documented and reviewed.2 What is novel about this study is that the effect of a single LipiFlow treatment was monitored and, on average, sustained through the 12-month study period.
At 12 months 86% of patients had received only a single LipiFlow treatment and did not require additional prescription therapy for Dry Eye symptoms. "The sustained results shown in this study are evidence that LipiFlow's inner-lid heat with combined vectored pulsation is uniquely effective. LipiFlow provides long-term improvement in meibomian gland function and Dry Eye symptoms. Whether alone or complemented with other prescription interventions, LipiFlow optimizes outcomes for Dry Eye sufferers," said Joseph Boorady, CEO of TearScience.
"Because MGD is chronic and progressive, it has long been suspected that early intervention is likely to yield increased benefits," said Edward J. Holland, MD, a study investigator and author of the publication. "Our study findings strongly suggest that screening for MGD and treating underlying gland dysfunction is an appropriate protocol for all patients, even in the absence of Dry Eye symptoms."
All device-related adverse events were anticipated, transient, nonserious ocular events that resolved without sequelae. The type and rate of nonserious and transient adverse events related to the LipiFlow® System in the study were consistent with prior studies.
The study, "The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye," was published in Clinical Ophthalmology.1
TearScience, a medical device company, has pioneered technologies and leads innovation to vastly improve evaluation of meibomian glands and treatment of meibomian gland dysfunction (MGD). A progressive, obstructive disease and root cause of Dry Eye, MGD is distinguished by loss of function and structure of tear oil (meibomian) glands. MGD affects approximately 86% of the millions of Dry Eye sufferers worldwide and is highly prevalent in the general ophthalmic population. LipiView II and new LipiScan with Dynamic Meibomian Imaging™ (DMI) distinctively image meibomian gland structure. The Korb Meibomian Gland Evaluator™ assists physicians to reproducibly assess gland function. LipiFlow uses Vectored Thermal Pulse™ (VTP) technology to precisely direct treatment from the inner-lid and has received clearance by the US Food and Drug Administration for use in patients with MGD. Sponsored and unsponsored multicenter, randomized, controlled clinical studies of LipiFlow demonstrate its safety and sustained effectiveness. For additional information on how TearScience improves evaluation of MGD, meibomian gland function, and symptoms for patients with MGD worldwide, visit www.TearScience.com.
1. Blackie CA, Coleman CA, Holland EJ. The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye. Clin Ophthal. 2016;10:1385-1396.
2. Blackie CA, Carlson AN, Korb DR. Treatment for meibomian gland dysfunction and dry eye symptoms with a single-dose vectored thermal pulsation: a review. Curr Opin Ophthalmol 2015;26:306-313.
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