On behalf of Sight Sciences, Inc., new data was reported during the 2024 American Society of Cataract and Refractive Surgery (ASCRS) annual meeting this past weekend from the crossover phase of the SAHARA randomized control trial (RCT).
The data detailed positive findings supporting the TearCare System as a primary treatment of dry eye disease (DED).
First, talk about this system.
TearCare is an FDA-cleared system that combines wearable and smart technology to provide localized heat therapy in adult patients diagnosed with evaporative DED due to meibomian gland dysfunction (MGD).
Its intent is to address the underlying root cause of MGD: obstructed meibomian glands.
Explain how it works.
The in-office, single-use treatment kit includes four electrothermal (SmartLid) devices adhesively affixed to the tarsal plate of each eyelid.
Each device conforms to the eyelid’s anatomy—allowing patients to blink while undergoing treatment—and are connected via a cable to the proprietaryTearCare controller.
The result: delivery of a regulated, targeted, thermal energy across the eyelids—all at a consistent therapeutic temperature range between 41°C–45°C.
What follows this thermal energy?
An in-office, manual meibomian gland expression that uses expression forceps to make sure all residual meibomian gland obstruction has (potentially) been cleared.
And the result?
A targeted and controlled delivery of thermal energy to the eyelids, plus two forms of meibomian gland obstruction expression:
- Natural blinking expression
- Mechanical expression
- Performed by a eyecare professional (ECP)
So how has the system performed clinically?
To get the rundown on its performance, we’ll need to refresh you on the original multi-center, prospective SAHARA RCT (NCT04795752).
Why?
This was the first RCT of its kind to evaluate interventional eyelids procedures (enabled by TearCare) vs Restasis (cyclosporine ophthalmic emulsion, 0.05%; AbbVie) eye drops administered twice a day (BID) in 245 DED patients.
What did it measure?
The primary endpoint (for assessing DED) included mean change from baseline in tear break-up time (TBUT) and ocular surface disease index (OSDI) scores.
Study evaluation period: 6 months
And the findings?
The trial achieved its primary endpoint, demonstrating TearCare enabled “superiority of interventional eyelid procedures” vs Restasis for TBUT improvement.
TearCare-based procedures also illustrated clinically and statistically significant improvements at each endpoint and time intervals—1 week, 1 month, 3 months, and 6 months for:
- TBUT
- Meibomian Gland Secretion Score (MGSS)
- Corneal and conjunctival staining
See here for our coverage on the complete 6-month findings.
Gotcha. Now let’s talk crossover details.
As the second phase of the SAHARA RCT, all patients originally randomized to receive Restasis (n = 164; 328 eyes) were switched to the TearCare System and monitored for an additional 6 months.
Outcome measures included:
- TBUT
- Ocular Surface Index (OSDI)
- MGSS
TBUT data first, please.
The mean (SD) baseline TBUT for these participants prior to Restasis treatment was 4.4 (1.2) seconds.
After 6 months of Restasis BID, this improved to 5.6 (2.7) seconds. This was followed by 6.6 (3.2), P<0.0001 and 6.1 (2.8), P=0.029 seconds at 9 and 12 months, respectively—also known as months 3 and 6 following TearCare treatment.
What about their OSDI scores?
The baseline mean OSDI was 50.0 (14.9) and 34.1 (21.5) following 6 months of Restasis.
With TearCare at 6 months, this improved to 30.0 (20.6) and 31.0 (19.5) at 9 and 12 months (P≤0.162 vs. Month 6, P<0.0001 vs. baseline)
And MGSS?
Participants’ MGSS was 7.1 (3.2) at baseline (prior to their initial 6-month Restasis treatment). At the end of those 6 months, it improved to 13.4 (8.3).
This further improved to 17.4 (8.8) and 16.1 (9.0) at 9 and 12 months (translation: 3 and 6 months of TearCare) treatment; both P<0.0001.
And the conclusions based on this data?
Presented by Brandon D. Ayres, MD, ABO, during ASCRS, the authors concluded that the extension data showed patients treated with Restasis for 6 months “can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single (TearCare) treatment without the need for topical prescription therapy.”
Dr. Ayres added: “These data once again support the conclusion that TearCare should be a preferred treatment for DED associated with meibomian gland dysfunction,”
BONUS: See here and click here for two other ASCRS presentations on clinical data supporting the use of TearCare for improving DED signs and symptoms.
The ASCRS / American Society of Ophthalmic Administrators (ASOA) annual meeting was held April 5-8, 2024, in Boston, Massachusetts.