TearCare wins FDA label update to improve meibomian gland function
Sight Sciences has secured an expanded FDA indication for its TearCare System, with the agency updating the device's labelling on 18 August 2026 to state that it "improves meibomian gland function in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands."
The Menlo Park company, listed on Nasdaq as SGHT, says the updated clearance makes TearCare the first and only MGD treatment with an indication tied to functional improvement of the glands themselves, rather than symptomatic relief. The label change also incorporates optional debridement as part of the TearCare procedure, broadening the system's scope of use.
The technology and clinical rationale
TearCare delivers precisely controlled thermal energy to the eyelids through the company's proprietary SmartLids technology, which is designed to maintain therapeutic heat across the meibomian glands while preserving natural blinking. The heat softens obstructive meibum, enabling clinician-directed manual expression to clear gland blockages.
MGD is widely recognised as the leading cause of evaporative dry eye disease, a condition affecting tens of millions of patients globally and associated with reduced visual quality, discomfort, and impaired daily functioning. Conventional treatments have historically focused on symptom management, including artificial tears, anti-inflammatory agents, and warm compresses, rather than on restoring gland function directly.
Paul Badawi, co-founder and chief executive of Sight Sciences, said the label update "represents a landmark moment for both the dry eye category and Sight Sciences," adding that it reflects the company's focus on addressing underlying disease mechanisms rather than consequences.
Neel R. Desai, Director of Cornea, Cataract, and Refractive Surgery at The Eye Institute of West Florida, said the recognition that TearCare improves meibomian gland function "validates the shift toward interventions designed to improve the function disrupted by MGD and raises the bar for what we should expect from treatment."
Market context and competitive landscape
The dry eye disease market is substantial and growing, driven by ageing populations, increased screen time, and rising rates of diagnosis. Competing thermal pulsation and gland-expression systems have been on the market for over a decade; LipiFlow, developed by Johnson & Johnson Vision, is the most established rival technology. Both systems apply heat to the eyelid to soften obstructive meibum, but until now neither held a meibomian gland function improvement claim in its approved indication.
The differentiated label wording could have meaningful commercial implications. Eye care providers navigating reimbursement discussions and product selection may give weight to a function-focused endpoint, which aligns with evolving clinical expectations for chronic disease management. Sight Sciences also markets the OMNI Surgical System for glaucoma, giving it an existing commercial footprint in ophthalmic procedure rooms that could support TearCare uptake.
The company did not release underlying clinical data alongside the announcement, so independent validation of the functional endpoint's durability and magnitude will be important for broad clinical adoption. The next milestone to watch is commercial traction and any reimbursement developments tied to the updated indication language.