EYECARE: Eye Health Sight Sciences Receives FDA 510(k) Clearance of the TearCare System for Treatment of Meibomian Gland Dysfunction, the Leading Cause of Dry Eye Disease By Staff Thursday, December 23, 2021 12:21 AM MENLO PARK, Calif.—Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, 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 eyecare 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. The FDA clearance is based on data from multiple studies of the TearCare System, including recent safety and effectiveness clinical data from the pivotal OLYMPIA study published in Cornea. “With such a significant number of DED cases caused by MGD, clinicians need a safe and effective modality to treat underlying meibomian gland obstruction in these patients,” said Preeya K. Gupta, MD, managing director of Triangle Eye Consultants and lead author of the OLYMPIA study. “While historic treatments for dry eye, such as artificial tears and prescription eye drops, help address symptoms of dry eye and other potential causes, treatments for MGD remain an essential therapy for our dry eye patients. The OLYMPIA study further validates the safety and efficacy of the TearCare System to treat MGD, and we are excited to offer our patients an FDA-cleared option that can help clinicians clear gland obstructions and deliver better outcomes for adult MGD patients,” Dr. Gupta said. Sight Sciences plans to continue research efforts to help support future indications for the TearCare System and to provide additional randomized, controlled clinical data, which the company believes could help support insurance coverage for the procedure in the future. The TearCare System consists of a reusable hardware controller, the SmartHub, and a software-controlled eyelid technology called the SmartLids. The SmartLids are applied adhesively and noninvasively to the outer surface of the eyelids and provide a universal and comfortable fit to deliver therapeutic heat within a tight therapeutic temperature window to the inner eyelid. The SmartHub system provides sensor-driven feedback to manage consistent heat of the SmartLids, and is designed to be portable and work into any office patient flow. The TearCare System leverages an open-eye design that allows patients to blink naturally throughout the procedure.