SGHT - Sight Sciences wins FDA clearance for TearCare System

Sight Sciences (NASDAQ:SGHT) has added ~1.2% in the pre-market after announcing that the FDA has issued 510(k) clearance for the company’s TearCare System for meibomian gland dysfunction (MGD), the main reason for dry eye disease (DED). The FDA has greenlighted TearCare System to provide localized heat therapy for adults with evaporative DED due to MGD in conjunction with the manual expression of the meibomian glands, which are blocked in MGD patients. The company says it plans to advance research to back further indications for the system and generate additional randomized, controlled clinical results which could potentially support the insurance coverage for the procedure. The FDA decision was based on data from several studies on TearCare System, including the pivotal OLYMPIA study, results of which were published in the journal Cornea, recently.

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Sight Sciences wins FDA clearance for TearCare System