The TearCare System is indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids.
When used in conjunction with manual expression of the meibomian glands, Sight Sciences is seeking an extended indication from the FDA for the use of localized heat therapy in adult patients with evaporative dry eye disease (DED) caused by meibomian gland dysfunction (MGD).
Evaporative DED, the most frequent kind of DED, is mostly caused by MGD. In clinic and population-based investigations, MGD is thought to be responsible for 86 percent of DED cases.
"Since MGD is associated with thickened or hardened oils in eyelid glands causing a deficient tear lipid layer and accelerated tear evaporation (evaporative dry eye), we believe that medical devices and procedures designed to apply controlled, therapeutic levels of heat to soften or liquify thickened meibum and alleviate eyelid gland obstructions are truly differentiated from eye drops for dry eye," Sight Sciences stated in a news release.
“I am very proud to be a part of this randomized trial, which was designed to evaluate the clinical effects of using eyelid-worn medical device technologies on key MGD-related signs and symptoms of DED,” Preeya K. Gupta, MD, Managing Director of Triangle Eye Consultants and first author of the study, said in the news release.
“Historically, the most common treatments for dry eye include artificial tears and prescription eye drops. Yet over time and as further validated by this study, we have come to realize the extreme importance of treating underlying meibomian gland obstruction.”
The OLYMPIA study enrolled a total of 135 adult subjects assigned to either a TearCare (n=67) or LipiFlow (n=68) treatment arm, each consisting of a single treatment.
TearCare's noninferiority to LipiFlow was determined by the mean change in primary effectiveness endpoints, such as Tear Break-Up Time (TBUT) and Total Meibomian Gland Secretion Score, from baseline to one month (MGSS).
Secondary effectiveness endpoints included the mean change from baseline to one month in Ocular Surface Disease Index (OSDI) score, corneal and conjunctival staining scores, Symptom Assessment in Dry Eye (SANDE) score, and Eye Dryness Score.
The primary safety endpoint was the incidence of ocular adverse events. The secondary safety endpoints included discomfort/pain during and after the procedures, change in Best Corrected Visual Acuity (BCVA), and change in intraocular pressure (IOP).
The noninferiority primary endpoints for TearCare were met in the study. Use of both TearCare and LipiFlow was associated with improvements in all assessed signs and symptoms of DED measured in the study. No subject in either group experienced any serious adverse events or device-related adverse events.
“Clinical results from the OLYMPIA study are extremely encouraging because they support the efficacy of treating MGD with a physician-directed intervention,” said Dr. Gupta.
“The goal is to melt and clear hardened, obstructive meibum to allow the meibomian glands to resume the production of healthy, liquid meibum that can then coat the aqueous and mucin components of the tear with every blink and prevent premature tear evaporation.”
“We are extremely proud that a peer-reviewed journal in eye care with a high impact factor like Cornea determined that the data from our OLYMPIA RCT were technically, scientifically and clinically compelling,” said Paul Badawi, Co-Founder and CEO of Sight Sciences.