Sight Sciences publishes results of SAHARA clinical trial for the treatment of dry eye disease

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Sight Sciences Inc announced the publication in Clinical Ophthalmology of the six-month primary results from the SAHARA randomized controlled trial (“RCT”).

“We are extremely pleased to have the successful six-month results of the SAHARA RCT now published in a peer-reviewed journal. The data from this trial support our belief in the clinical efficacy of interventional eyelid procedures enabled by TearCare technology versus the most commonly prescribed dry eye therapeutic for meibomian gland dysfunction,” said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences. “We plan to now focus on sharing these results with Medicare and commercial payors as we pursue fair and reasonable reimbursed market access to our technology.”

The data generated in the SAHARA RCT demonstrates that interventional eyelid procedures for dry eye disease enabled by TearCare technology (“TearCare”) were superior at all measured time points through 6 months to twice daily Restasis® prescription eyedrops (“Restasis”) for the improvement of tear break up time (“TBUT”), the trial’s primary dry eye signs endpoint and a key measure of aqueous retention, tear stability and the tear film’s ability to protect the ocular surface.¹

"While RESTASIS has been a longstanding staple in dry eye therapy, the findings from the SAHARA RCT, highlighting the efficacy of TearCare in addressing the underlying causes of evaporative dry eye, encourage a reconsideration of prioritizing interventional treatment over a prescription-based approach," remarked Brandon Ayres, MD, Co-Director of the Cornea Fellowship Program at Wills Eye Hospital and a Principal Investigator for the SAHARA clinical trial.

TearCare was also superior to Restasis in several other important objective signs of dry eye and delivered statistically significant and clinically meaningful improvements from baseline in all other measures that were at least as good as Restasis at all time points. SAHARA included 345 subjects at 19 sites in 11 states randomized 1:1 to either TearCare or Restasis.

TearCare and Restasis delivered clinically comparable 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 symptoms endpoint.

SAHARA Phase I Complete Results:

• TearCare was superior to Restasis in the objective improvement of TBUT at every time point measured (one week, one month, three months, and six months). Patients receiving TearCare treatments exhibited statistically significant improvements in TBUT from baseline as early as one week, reaching a 2.4-second improvement from baseline at six 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.
• TearCare and Restasis both demonstrated comparable statistically significant improvements at all time points measured for corneal and conjunctival staining, key indicators of corneal and conjunctival health. TearCare and Restasis delivered comparable statistically significant 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 assess dry eye severity subjectively.

In the next phase 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 six 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. The Company expects publication of the 1-year crossover clinical results by year-end 2024.

Authors and affiliations: Brandon D Ayres MD (Private Practice), Marc R Bloomenstein OD of Schwartz Laser Eye Center, Jennifer Loh MD of Loh Ophthalmology Associates, Thomas Chester OD of Cleveland Eye Clinic, Bobby Saenz OD MS of Rosenberg School of Optometry and Lasik San Antonio, Julio Echegoyen MD PhD of Gordon Schanzlin New Vision Institute, Shane R Kannarr OD of Kannarr Eye Care, Victor L Perez MD of Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Jaime E. Dickerson Jr., PhD of Sight Sciences and University of North Texas Health Science Center, and Afua Ohene-Nyako of Sight Sciences.

Reference:

1. Ayres BD et al. A Randomized, Controlled Trial Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA). Clinical Ophthalmology (2023) Volume 17 Pages 3925-3940. https://www.dovepress.com/a-randomized-controlled-trial-comparing-tearcare-and-cyclosporine-opht-peer-reviewed-fulltext-article-OPTH