Sight Sciences Presents Phase 1 Results of the SAHARA Trial Comparing TearCare to Restasis for the Treatment of Dry Eye Disease

Sight Sciences announced the presentation of the full phase 1 results from the SAHARA randomized controlled trial, demonstrating that interventional eyelid procedures for dry eye disease enabled by TearCare technology were superior at all measured time points to Restasis prescription eye drops for the improvement of tear break up time—the trial’s primary objective endpoint and a key measure of aqueous retention—tear stability, and the tear film’s ability to protect the ocular surface. TearCare and Restasis also delivered comparable clinically and statistically significant improvements at every time point measured in patient reported outcomes measured by Ocular Surface Disease Index (OSDI) scores, the trial’s primary subjective endpoint, according to Sight Sciences.

These results were presented at the American Academy of Optometry’s annual meeting in New Orleans.

“Pharmaceutical intervention with Restasis has been the hallmark of dry eye treatment since its introduction. The results of the SAHARA RCT utilizing TearCare technology, which treats the root cause of dry eye disease, should make us rethink our options for the optimal treatment for dry eye,”  Marc Bloomenstein, OD, FAAO, Director of Optometric Services, Schwartz Laser Eye Center, and a Principal Investigator for the SAHARA clinical trial, said in a company news release. “Knowing we can achieve superior dry eye results with a procedure that also reduces concerns for daily prescription eye drop patient compliance and adherence should make my colleagues in eye care, as well as insurance providers, consider providing our patients access to TearCare as an efficacious and durable interventional dry eye treatment.”

The study also demonstrated that TearCare was superior to Restasis in several other important objective signs of dry eye and delivered statistically significant improvements from baseline in all other measures that were at least as good as Restasis at all measured time points, according to Sight Sciences. SAHARA included 345 subjects at 25 sites in 14 states randomized 1:1 between TearCare and Restasis groups. Results are expected to be published in a peer-reviewed journal in late 2023.

SAHARA Phase I Complete Results:

• TearCare was superior to Restasis in the objective improvement of tear break up time at every time point measured (1 week, 1 month, 3 months, and 6 months). Patients receiving TearCare treatments exhibited statistically significant improvements in tear break up time from baseline that increased from a 1.5-second improvement from baseline at one week to a 2.5-second improvement from baseline at 6 months.
• TearCare was also superior to Restasis in three other objective functional assessments of the underlying health of the meibomian glands, including meibomian gland secretion score, the number of glands yielding any liquid, and the number of glands yielding clear liquid.
• On corneal and conjunctival health improvements as measured by corneal and conjunctival staining, patients in the TearCare and Restasis groups demonstrated comparable statistically significant improvements at all time points measured.
• TearCare and Restasis delivered comparable statistically significantly improvements in tear production, as measured by Schirmer Test. Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
• TearCare and Restasis also delivered comparable statistically significant clinical improvements in OSDI scores, Symptoms Assessment in Dry Eye (SANDE) scores, and Eye Dryness Scores (EDS), patient reported outcomes to subjectively assess dry eye severity.
• Link to full presentation: https://ssi.onl/sahara

* At all time points, both groups significantly improved from baseline, P<0.0001

“We are extremely pleased with the successful 6-month results of the SAHARA RCT. The data from this trial support our belief in the clinical superiority of interventional eyelid procedures enabled by TearCare technology versus the most commonly prescribed dry eye therapeutic,” said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences. “We focus on equipping our ophthalmic and optometric customers with interventional technologies and procedures that can comprehensively address the underlying causes of eye disease and restore functionality, thereby elevating the standard of care. This is evident in both our Trabeculocanalicular Outflow Restoration procedure (TCOR) with OMNI technology for primary open-angle glaucoma, as well as our focus on the functional restoration of the meibomian glands with TearCare technology for evaporative dry eye. The SAHARA trial demonstrates the rigor we embrace in designing clinical trials to establish both the clinical and health economic value of our products and procedures for all stakeholders.”

In Phase II of the SAHARA trial, subjects in the Restasis cohort cease use of Restasis, receive an interventional eyelid procedure with TearCare, and will be monitored for another 6 months. Subjects in the TearCare cohort will receive additional interventional eyelid procedures as necessary based on pre-determined criteria over an additional 18 months (24 months total study period) to measure the durability of procedural treatment effect.