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Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has cleared an updated label for the TearCare heat therapy system, making it the first and only treatment specifically indicated to improve meibomian gland function in evaporative dry eye disease. The new label applies when TearCare is used alongside manual gland expression. Competing treatments like LipiFlow and Restasis lack this specific FDA indication.
The FDA has cleared an updated label for Sight Sciences' TearCare heat therapy system, making it the first treatment specifically indicated to improve meibomian gland (MG) function in evaporative dry eye disease (EDE). The updated indication applies when TearCare is used in conjunction with manual expression of the meibomian glands in adult patients.
This sets TearCare apart from competitors. While treatments like Johnson & Johnson's LipiFlow and AbbVie's Restasis have shown benefits in dry eye management, neither carries this specific FDA indication — LipiFlow is labeled for "localized heat and pressure therapy," and Restasis is indicated to "increase tear production."
The expanded label was supported by the OLYMPIA and SAHARA clinical studies, which compared TearCare to LipiFlow and Restasis, respectively, across endpoints including meibomian gland secretion score, gland quality, Ocular Surface Disease Index, and tear breakup time.
Key Takeaways:
Why it matters: For clinicians treating dry eye disease, this label update provides a clearer, evidence-backed rationale for choosing TearCare as an earlier intervention — potentially changing how treatment success is defined and measured in MGD management.
