Sight Sciences Announces Positive Clinical Results From TearCare Trial

Sight Sciences Inc., a growth-stage medical device company transforming the two fastest-growing segments in ophthalmology and optometry, glaucoma and dry eye disease, announced new dry eye clinical data from a multicenter trial of TearCare, the world’s first wearable eyelid technology for dry eye. 
 
The OLYMPIA study, a prospective, randomized multicenter trial, enrolled 235 dry eye patients at 10 U.S. sites. The trial was designed to demonstrate the safety and effectiveness of a single TearCare procedure compared to a single LipiFlow Thermal Pulsation System (Johnson & Johnson, Jacksonville, Fla.) procedure in treating the signs and symptoms of dry eye disease.
 
Results from the study found that a single TearCare treatment safely and effectively achieved clinically meaningful improvements in all signs and all symptoms of dry eye disease (i.e., all p values <0.01). Improvement in signs include: tear break-up time, meibomian gland secretion score, and corneal and conjunctival staining. Improvement in symptoms include: ocular surface disease index score (OSDI), symptom assessment in dry eye score (SANDE) and eye dryness score (EDS). The non-inferiority objectives for the primary endpoints, tear break-up time and meibomian gland secretion scores, were met. Markedly, a significantly greater proportion of TearCare patients showed clinically meaningful symptomatic relief compared to LipiFlow patients, with 72 percent of TearCare vs. 59 percent of LipiFlow subjects improving by at least one OSDI category. As a result of their significant symptomatic improvement, TearCare subjects required 22 percent less lubricant drops than LipiFlow subjects throughout the study. Adverse events reported in the study were minor (seven in the TearCare group and nine in the LipiFlow group), and resolved without requiring any further treatment.
 
“The positive signs and symptoms findings from the OLYMPIA trial adds to the growing body of evidence showing that the first-of-its-kind TearCare procedure is a truly effective treatment for meibomian gland dysfunction and dry eye disease,” said Kavita Dhamdhere, M.D., Ph.D., vice president of Clinical Development at Sight Sciences. “As the leading cause of visits to an eye care provider, dry eye disease can damage the ocular surface and cause great discomfort for patients. We are particularly excited about two key findings from our pivotal trial: first, that a single TearCare treatment delivered clinically meaningful and statistically significant improvements across the board for all dry eye signs and symptoms, and second, that there was a clinically meaningful percentage of TearCare patients (72% TearCare vs. 59% LipiFlow) who experienced significant symptomatic benefit.”
 
“Dry eye is an increasingly common disease, and there is a significant unmet need for an effective treatment that provides significant symptomatic relief,” said Jennifer Loh, M.D., practicing ophthalmologist at Loh Ophthalmology in Miami, Fla. “Having used TearCare for the past year, I have found that the procedure delivers rapid results and consistently high effectiveness for my dry eye patients. It is exciting and encouraging to see that the results of this randomized controlled trial are consistent with my real-world experience and underscore the reason I offer TearCare to my patients—notably that TearCare delivers more symptomatic relief for patients than any other options in this category, as evidenced by an unprecedented and high rate of subjects (72 percent) whose symptoms had clinically meaningful improvement by at least one OSDI category within a month.”
 
TearCare is the world’s first wearable and intelligent eyelid technology for dry eye treatment. Through a combination of proprietary eyelid innovations including wearability, total tarsal conformance, blink assistance, and software-sensor controlled thermal optimization, TearCare safely, consistently, and non-invasively achieves and maintains the elevated tarsal conjunctival temperatures required to melt and clear gland obstructions thereby restoring the critical oil-producing function of the meibomian glands within the eyelid.
 
TearCare is currently indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, or Blepharitis.