MENLO PARK, Calif., May 18, 2020 /PRNewswire/ — Sight Sciences, Inc., a growth-stage medical device company transforming the two fastest-growing segments in ophthalmology and optometry, glaucoma and dry eye disease, today announced new dry eye clinical data from a multicenter trial of TearCare®, the world’s first wearable eyelid technology for dry eye. Data from the study were presented at the American Society of Cataract Refractive Surgery (ASCRS) Virtual Annual Meeting by Jennifer Loh, M.D., practicing Ophthalmologist at Loh Ophthalmology in Miami, Fla.
The OLYMPIA study, a prospective, randomized multicenter trial, enrolled 235 dry eye patients at ten (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., USA) 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% of TearCare vs. 59% of LipiFlow subjects improving by at least one OSDI category. As a result of their significant symptomatic improvement, TearCare subjects required 22% 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 Dr. Loh. "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%) 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.
About Sight Sciences
Founded in 2011, Sight Sciences develops and commercializes intelligently designed and engineered products that target the underlying causes of the world’s most prevalent eye diseases. The company’s surgical glaucoma product portfolio features the OMNI® Surgical System, a dually-indicated MIGS device that facilitates the performance of both ab interno trabeculotomy and transluminal viscoelastic delivery. Using proprietary multi-modal functionality, OMNI allows surgeons to target of all three sources of resistance in the conventional outflow pathway (trabecular meshwork, Schlemm’s canal, and collector channels) with a single device and single corneal incision.
The company’s non-surgical Dry Eye product portfolio consists of TearCare® for ophthalmologists and optometrists. TearCare is a software-controlled, wearable, therapeutic eyelid technology designed to melt and clear obstructions of the meibomian glands within the eyelids. Leveraging the full functionality of the blinking eye, proprietary SmartLid™ technology is designed to conform to all eyelid anatomies and achieve therapeutic meibum melting temperatures at the tarsal conjunctiva thereby clearing meibomian gland obstructions while sparing the cornea. Improved meibum production results in a higher quality lipid layer and higher quality tears.
For more information, please visit sightsciences.com.
Dr. Loh is a paid consultant to Sight Sciences.
TearCare® and OMNI® are registered trademarks of Sight Sciences.
© 2020 Sight Sciences. All rights reserved.
SOURCE Sight Sciences, Inc.