Fresh off of last week’s FDA clearance news, Sight Sciences, Inc. announced another regulatory update: The FDA has expanded TearCare System’s indication for use in treating meibomian gland dysfunction (MGD) patients.
Big news! But first, let’s get a look at the TearCare System.
What it is: Designed as a wearable and smart technology, this in-office treatment provides localized heat therapy to address the underlying root cause of MGD: obstructed meibomian glands (MGs).
- Its initial FDA 510(k) clearance: In 2021 as a Class II medical device.
- See what comes with the eyelid thermal pulsation system.
- Click here (plus here) for clinical data supporting its durability for dry eye.
Expand on this heat therapy component.
TearCare runs on Thermal-Activated Restorative Gland Expression Therapy (TARGET) technology, which clears obstructed meibomian glands (MGs) to restore their natural function. Two parts:
- Thermal activation: Controlled heat applied to the eyelid softens and melts the thickened oils clogging the glands.
- Restorative gland expression: An eyecare provider (ECP) then clears any residual blockage with expression forceps.
The result is more precise, controlled energy delivery to the lids—plus MG expression from two directions: natural blinking during treatment and mechanical expression by the provider.
And how long is this entire process?
Around 12(ish) minutes, from start to finish.
Noted. Now let’s talk indication.
The original indication: Intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to (MGD), when used in conjunction with manual expression of the meibomian glands.
And the update: We’ll use the exact verbiage, as per the company:
- A thermal-activated gland expression therapy that improves meibomian gland function in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.
Explain the difference.
There’s two: The description of what the TearCare System is and what the device does (its purpose, essentially).
Regarding that first component: The original indication referred to the TearCare System as “application of heat therapy” whereas the updated indication uses the terms “thermal-activated gland expression therapy.”
And second: The original indication doesn’t note any “effect” the system provides; instead, it only describes its energy delivery.
The updated indication, on the other hand, says the system “improves meibomian gland function.”
- In other words: The new wording states what the therapy actually accomplishes: restored gland function.
Anything else?
The label expansion also incorporates an optional debridement as a procedural step prior to receiving heat therapy from the TearCare System.
Got it. And what’s the significance of these changes?
Thanks to the addition of that second piece, Sight Sciences says TearCare is now “the first and only treatment for MGD indicated to improve MG function” among DED patients.
Co-founder and CEO Paul Badawi also referred to the label expansion as representative of “a landmark moment” for the company and the dry eye space.