Key Takeaways

• The FDA updated TearCare's indication to include improving meibomian gland function in adults with dry eye disease due to meibomian gland dysfunction (MGD); it is the first and only treatment with this indication.
• TearCare is designed to address MGD using targeted thermal energy to soften obstructive meibum and, when combined with manual expression, clear gland obstructions.
• The expanded indication reinforces the importance of addressing MGD as an underlying cause of dry eye disease.

The FDA expanded the indications for use for the TearCare System (Sight Sciences), making it the first and only treatment for meibomian gland dysfunction (MGD) indicated to improve meibomian gland function in patients with dry eye disease.

The updated indications for use states: "The Sight Sciences TearCare System is a thermal-activated gland expression therapy that improves meibomian gland function in adult patients with evaporative dry eye disease due to MGD, when used in conjunction with manual expression of the meibomian glands."

Meibomian gland dysfunction is a leading cause of evaporative dry eye disease, affecting millions of patients and impacting visual quality, ocular comfort, and daily vision-related activities. The updated FDA indication reinforces the importance of addressing meibomian gland dysfunction as an underlying cause of dry eye disease while providing eye care providers with a clinically meaningful endpoint focused on gland function.

"This label expansion represents a landmark moment for both the dry eye category and Sight Sciences," said Paul Badawi, cofounder and CEO of Sight Sciences. "For the first time, eye care providers and patients have a treatment indicated to improve meibomian gland function for evaporative dry eye disease due to MGD. This important milestone reflects our commitment to advancing the science of interventional dry eye disease and providing eye care providers and patients with technologies that address the underlying cause, not just symptoms."

“For chronic, progressive diseases like dry eye disease and glaucoma, meaningful treatment should ultimately be measured by what we can do to preserve or improve physiological function—not simply manage the consequences of disease,” said Neel R. Desai, MD, director of cornea, cataract, and refractive surgery at The Eye Institute of West Florida. “The recognition that TearCare improves meibomian gland function represents an important evolution in dry eye care. It validates the shift toward interventions designed to improve the function disrupted by MGD and raises the bar for what we should expect from treatment.”

The TearCare System is designed to address meibomian gland dysfunction through precisely controlled, targeted thermal energy delivered directly to the eyelids while preserving natural blinking. Its proprietary SmartLids technology maintains therapeutic heat across the meibomian glands, helping soften obstructive meibum and, when combined with clinician-directed manual expression, effectively clear gland obstructions and improve meibomian gland function.

The updated clearance not only expands TearCare's indication to include improvement of meibomian gland function but also incorporates optional debridement as part of the TearCare System, further enhancing its comprehensive approach to treating evaporative dry eye disease due to MGD.