FDA Clears Expanded Indication for TearCare System to Improve Meibomian Gland Function in Evaporative Dry Eye Disease
The US Food and Drug Administration (FDA) has cleared an expanded label for the TearCare heat therapy system (Sight Sciences) specifically targeting the restoration of meibomian gland function. According to the manufacturer, the device is indicated to:
Emphasizing the clinical shift toward earlier therapeutic intervention, Matt Gibson, senior director of marketing, interventional dry eye, at Sight Sciences, remarked:
Gibson further noted that the regulatory label:
Regulatory Differentiation and Comparative Indications
While other pharmacologic and device-based interventions have documented functional improvements in the meibomian glands, they do not carry this specific clearance from the FDA.
Table 1. Comparative Analysis of FDA Indications for Selected Dry Eye Therapies
| Product / Device | Manufacturer | Regulatory Class / Modality | Specific FDA Label / Intended Use |
| TearCare System | Sight Sciences | Thermal adaptive heat therapy + manual expression | Cleared to improve meibomian gland function in adult patients with evaporative dry eye disease due to MGD (in conjunction with manual expression) |
| TearScience LipiFlow | Johnson & Johnson | Localized thermal pulsation therapy | Intended โfor the application of localized heat and pressure therapyโ in MGD |
| Restasis (cyclosporine ophthalmic emulsion 0.05%) | AbbVie | Topical calcineurin inhibitor immunomodulator | Indicated โto increase tear productionโ in patients with ocular inflammation associated with keratoconjunctivitis sicca |
Clinical Trial Evidence
The regulatory expansion was supported by clinical outcomes from two comparative trials: the OLYMPIA study (evaluating TearCare vs LipiFlow) and the SAHARA study (evaluating TearCare vs Restasis). Across both trials, investigators assessed primary and secondary functional endpoints alongside patient-reported symptom scores.
Table 2. Supporting Clinical Trial Framework and Evaluated Endpoints
| Study Name | Comparative Arms | Evaluated Clinical Endpoints | Reported Efficacy Outcome |
| OLYMPIA | TearCare vs LipiFlow (TearScience) | * Meibomian Gland Secretion Score (MGSS) * Meibomian Glands Yielding Any Liquid (MGYAL) * Ocular Surface Disease Index (OSDI) * Tear Breakup Time (TBUT) | Demonstrated non-inferior/superior functional and symptomatic improvements via thermal adaptive expression |
| SAHARA | TearCare vs Restasis (cyclosporine 0.05%) | * Meibomian Gland Secretion Score (MGSS) * Meibomian Glands Yielding Any Liquid (MGYAL) * Ocular Surface Disease Index (OSDI) * Tear Breakup Time (TBUT) | Sustained enhancement of gland secretion and tear film stability vs topical pharmacotherapy |
Regarding these outcome parameters, Gibson stated:
Pathophysiologic Considerations and Clinical Goals
Meibomian gland dysfunction represents a chronic condition requiring targeted therapeutic strategies to prevent terminal anatomical loss. Gibson underscored the urgency of physiological preservation:
He concluded that this disease progression:
Conflict of Interest Disclosures
Matt Gibson reports being senior director of marketing, interventional dry eye, at Sight Sciences.
