Sight Sciences, Inc. released six-month data from their SAHARA randomized control trial (RCT), designed to compare the use of the company’s TearCare System to Restasis eye drops for the treatment of dry eye disease (DED).
Talk to me about TearCare.
FDA cleared, the TearCare System incorporates wearable and smart technology to provide localized heat therapy in adult patients diagnosed with evaporative DED due to meibomian gland dysfunction (MGD).
Essentially, TearCare works to address the underlying root cause of MGD: obstructed meibomian glands.
How does it work?
The in-office, single-use treatment kit includes four electrothermal (SmartLid) devices adhesively affixed to the tarsal plate of each eyelid.
These devices shape to conform to the eyelid’s anatomy—enabling patients to blink while undergoing treatment—and are connected via a cable to the proprietaryTearCare controller which allows for the delivery of a regulated, targeted, thermal energy across the eyelids (all at a consistent therapeutic temperature range between 41°C–45°C).
The thermal energy is followed by an in-office, manual meibomian gland expression using the expression forceps to ensure all residual meibomian gland obstruction has been potentially cleared.
And this leads to …
Ideally, for a more precise and controlled delivery of thermal energy to the eyelids as well as two forms of meibomian gland obstruction expression:
- Natural blinking expression
- Mechanical expression (performed by an eyecare provider [ECP])
Gotcha. Now tell me about this study.
The SAHARA study (NCT04795752) is the first multicenter, prospective RCT targeted toward assessing interventional eyelids procedures (enabled by TearCare) compared to Restasis (cyclosporine ophthalmic emulsion, 0.05%) eye drops administered twice a day (BID).
And the patients?
A total of 345 patients (22+ years of age) at 25 locations across 14 states were randomized 1:1 to receive either TearCare or Restasis drops.
See here for the full inclusion criteria.
Talk about the investigation process for a moment.
The process is masked by having one investigator conduct the procedure and a separate investigator evaluate the results.
How were they tested?
TearCare-treated patients underwent an in-office eyelid debridement, 15-minute bilateral, precision-controlled thermal session with TearCare, which was then followed by a manual expression of the meibomian glands (conducted by an ECP).
Restasis-treated patients self-administered one drop of the eye drop, BID, each day for 6 months; clinical assessments were completed at the 6-month point.
To note, the doctor investigating all measures/results of therapy was not aware of whether the patient was on Restasis or got TearCare as they didn’t perform the procedure or start the patient into the study.
What’s being measured?
The primary endpoint (for assessing DED) included mean change from baseline in tear break-up time (TBUT) and ocular surface disease index (OSDI) scores.
So … what were the 6-month findings?
According to the company, the trial achieved its primary endpoint, demonstrating the TearCare-enabled “superiority of interventional eyelid procedures” vs Restasis for TBUT improvement.
TearCare-based procedures also demonstrated clinically and statistically significant improvements at each endpoint and time intervals—1 week, 1 month, 3 months, and 6 months—for TBUT, meibomian gland score, corneal staining, and conjunctival staining.
How were symptoms assessed?
Patients reported their symptoms using the OSDI and Symptom Assessment iN Dry Eye (SANDE) questionnaires.
Ok .. so what happens after 6 months?
At that point, patients in the TearCare group will be administered additional interventional eyelid procedures as necessary (and based on pre-determined criteria over an additional 18 months) in order to measure the procedure’s treatment efficacy.
And the Restasis group?
According to the company, Restasis-treated patients will cross over to the TearCare group and be administered the TearCare procedure; following this, patients will be followed for an additional 18 months (for a total of 24 months).
Any other information to share?
Not at the moment… however, the company plans on presenting a more in-depth analysis of the data at the American Academy of Optometry’s (AAO) annual meeting in New Orleans, Louisiana, in October 2023.
When can we expect final results?
Sight Sciences expects the final data readout by 2025.
And the significance?
As the largest RCT with the longest follow-up analysis for DED, the data could support the use of TearCare over Restasis for treating DED associated with MGD.
Go on ...
Pending results, Sight Sciences plans to present the data to managed care organizations with the objective to acquire coverage and payment via insurance plans that provide insured access for patients and fair reimbursement for ECPs.