FDA expands TearCare indication to improve meibomian gland function

The FDA has expanded the indications for use of the TearCare System (Sight Sciences) to include improvement of meibomian gland function in adult patients with evaporative dry eye disease because of meibomian gland dysfunction (MGD). The 510(k)-cleared device is now the first and only treatment indicated to improve meibomian gland function in this patient population.

The updated indications for use state that the TearCare System is a thermal-activated gland expression therapy that improves meibomian gland function in adult patients with evaporative dry eye disease because of MGD, when used in conjunction with manual expression of the meibomian glands. MGD is a leading cause of evaporative dry eye disease, affecting millions of patients and significantly impacting visual quality, ocular comfort, and daily vision-related activities.

"The recognition that TearCare improves meibomian gland function represents an important evolution in dry eye care," Neel R. Desai, MD, director of cornea, cataract, and refractive surgery at The Eye Institute of West Florida, said in a statement.¹² Desai said meaningful treatment for chronic, progressive diseases like dry eye disease and glaucoma should ultimately be measured by preservation or improvement of physiological function, not simply management of disease consequences, and that the new indication validates a shift toward interventions designed to improve the function disrupted by MGD.

Device delivers targeted thermal energy to clear gland obstructions

TearCare delivers precisely controlled, targeted thermal energy directly to the eyelids while preserving natural blinking, using proprietary SmartLids technology to maintain therapeutic heat across the meibomian glands. The heat softens obstructive meibum and, when combined with clinician-directed manual expression, clears gland obstructions and improves meibomian gland function.

The updated clearance also incorporates optional debridement as part of the TearCare System, extending its approach to treating evaporative dry eye disease because of MGD. Sight Sciences, based in Menlo Park, California, also markets the OMNI and OMNI Edge surgical systems for glaucoma and the SION surgical system.

"This label expansion represents a landmark moment for both the dry eye category and Sight Sciences," Paul Badawi, cofounder and CEO of Sight Sciences, said in a statement. Badawi said the indication gives eye care providers and patients, for the first time, a treatment indicated to improve meibomian gland function for evaporative dry eye disease because of MGD, reflecting the company's commitment to addressing the underlying cause of disease rather than managing symptoms alone.

Frequently Asked Questions

• What is TearCare approved for?
  The FDA-expanded indication approves TearCare to improve meibomian gland function in adult patients with evaporative dry eye disease because of MGD, when used with manual expression of the meibomian glands.
• How does TearCare work?
  The device delivers targeted thermal energy to the eyelids via proprietary SmartLids technology, softening obstructive meibum so that clinician-directed manual expression can clear gland obstructions and improve gland function.
• What should optometrists know about TearCare?
  TearCare is now the first and only MGD treatment indicated to improve meibomian gland function, giving optometrists a treatment option with a clinically meaningful endpoint focused on gland function rather than symptom management alone.

References

1. Sight Sciences, Inc. TearCare Becomes the First and Only MGD Treatment Indicated to Improve Meibomian Gland Function in Patients With Evaporative Dry Eye Disease. News release. Published August 19, 2026. Accessed August 24, 2026. https://www.biospace.com/press-releases/tearcare-becomes-the-first-and-only-mgd-treatment-indicated-to-improve-meibomian-gland-function-in-patients-with-evaporative-dry-eye-disease