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Sight Sciences Announces TearCare® Clinical Data Published in Cornea
Clinical trial data being used to seek expanded indication from the FDA MENLO PARK, Calif., Oct. 20, 2021 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq:
About this update from Sight Sciences, Inc.
[{"type":"text","content":"Clinical trial data being used to seek expanded indication from the FDA\nMENLO PARK, Calif., Oct. 20, 2021 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), a growth-stage medical device company focused on addressing the underlying causes of the world's most prevalent eye diseases, today announced publication in the journal Cornea of positive results from OLYMPIA, a multicenter, investigator-masked, randomized controlled trial. The TearCare® System is presently 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. “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,” said Preeya K. Gupta, MD, Managing Director of Triangle Eye Consultants and first author of the study. “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 non-inferiority of TearCare to LipiFlow, measured by the mean change from baseline to one month in primary eff...