Sight Sciences Announces TearCare Clinical Data Published in Cornea
Sight Sciences announced publication in the journal Cornea of positive results from OLYMPIA, a multicenter, investigator-masked, randomized controlled trial.
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. Sight Sciences is currently seeking an expanded indication from the FDA for the application of localized heat therapy in adult patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.
MGD is the primary underlying cause of evaporative DED, the most common type of DED. It is estimated that MGD underscores 86% of DED cases in clinic and population-based studies.
"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. The study was designed to show the noninferiority of TearCare to LipiFlow, measured by the mean change from baseline to one month in primary effectiveness endpoints, including Tear Break-Up Time (TBUT) and Total Meibomian Gland Secretion Score (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 eyecare 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. “Our mission at Sight Sciences is to transform eyecare by developing and delivering clinically differentiated solutions that allow eyecare providers to comprehensively and consistently address the root underlying causes of eye disease. It is extremely gratifying to our entire team, as well as our OLYMPIA clinical partners, both ophthalmologists and optometrists, that such an important step in our missionary work to develop products and product candidates for use in procedures that can transform the treatment paradigm in dry eye from eyedrops to procedural interventions was recognized by the leading journal in ocular surface disease.”