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Sight Sciences Receives FDA 510(k) Clearance of the TearCare® System for Treatment of Meibomian Gland Dysfunction (MGD), the Leading Cause of Dry Eye Disease
Label expansion for evaporative dry eye due to MGD will support further efforts to drive patient access to insurance-covered TearCare treatments MENLO PARK,
About this update from Sight Sciences, Inc.
[{"type":"text","content":"Label expansion for evaporative dry eye due to MGD will support further efforts to drive patient access to insurance-covered TearCare treatments\nMENLO PARK, Calif., Dec. 22, 2021 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the TearCare® System for the treatment of meibomian gland dysfunction (MGD), the leading cause of dry eye disease (DED). The indication clears TearCare for the application of localized heat therapy in adult patients with evaporative DED due to MGD, when used in conjunction with manual expression of the meibomian glands. Present in the vast majority of DED cases, MGD is largely undertreated, with no insured treatment options currently available that can address MGD as the root cause of dry eye. Meibum, a clear, oily secretion that is expressed through the eye’s meibomian glands, works to coat the outermost layer of the eye and protect tears from premature evaporation. In MGD, there is abnormal thickening or hardening of meibum, and the opening of meibomian glands can become blocked, preventing meibum from reaching the tear. If left untreated, MGD can present serious consequences, including ocular surface damage, changes in tear film stability, inflammation, pain, chronic dry eye, and other symptoms that can greatly impair a person’s daily life and vision. The eye care community is increasingly acknowledging the importance of treating underlying meibomian gland obstruction when present for optimal treatment of DED associated with MGD. The TearCare System provides safe and effective localized heat therapy, in conjunction with manual gland expression, intended to help soften or liquify thickened meibum for effective gland clearance. The TearCare System’s intelligent design delivers a consistent, requisite level of therapeutic heat (45 degrees Celsius) to the outer surface of the eyelids to achieve and maintain an inner eyelid temperature of 41-42 degrees Celsius — the inner eyelid temperature necessary to melt meibum. Research on the optimal melting temperature of hardened meibum suggests that precise heat delivery within this tight therapeutic temperature window is critical to achieving ...