FDA grants 510(k) clearance for Sight Sciences’ TearCare System
11 January 2022
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Sight Sciences’ TearCare System to treat meibomian gland dysfunction (MGD), which causes dry eye disease (DED).
The regulatory approval allows the TearCare System to provide localised heat therapy in adults when used in conjunction with the manual meibomian glands expression.
This therapy will be provided for adult patients with evaporative DED caused due to MGD.
The system provides localised heat therapy to help soften or liquify thickened meibum to enable effective gland clearance.
It comprises SmartHub, a reusable hardware controller, as well as SmartLids, a software-controlled eyelid technology.
The SmartLids are applied to the outer surface of the eyelids to fit to provide heat therapy within a tight therapeutic temperature window to the inner eyelid.
The portable SmartHub system offers sensor-driven feedback for the management of SmartLids’ heat.
Sight Sciences co-founder and CEO Paul Badawi said: “The entire Sight Sciences community is committed to advancing treatment for MGD patients and expanding much needed patient access to insured treatment.
“MGD is the leading cause of DED and can present serious complications for patients if left untreated, yet both the understanding and treatment of MGD as the underlying cause of dry eye is still evolving.
“We remain dedicated to bringing an insurance recognised treatment option to the millions of underserved patients living with MGD.”
The approval was based on the data obtained from several studies, including the pivotal OLYMPIA study.
The company plans to continue the research support for the TearCare System’s future indications to provide additional clinical data that could potentially support insurance coverage for the procedure.
In 2019, Sight Sciences commenced patient enrolment for the Gemini clinical trial to evaluate safety and efficacy of the OMNI Surgical System.
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Also published on Medicaldevice-network.com