Sight Sciences, Inc.NASDAQ: SGHT

Sight Sciences Announces Presentation of Successful Phase I Results of the SAHARA Randomized Controlled Clinical Trial Comparing TearCare® to Restasis® for the Treatment of Dry Eye Disease at the American Academy of Optometry Annual Meeting

· Issued by Sight Sciences, Inc. via GlobeNewswire

Interventional eyelid procedures enabled by TearCare technology successfully delivered clinically and statistically significant improvements in every sign and symptom measured at every time point through six months

MENLO PARK, Calif., Oct. 12, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences,” or the “Company”), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients’ lives, today announced the presentation of the full phase I results from the SAHARA randomized controlled trial (“RCT”), demonstrating that interventional eyelid procedures for dry eye disease enabled by TearCare technology (“TearCare”) were superior at all measured time points to Restasis prescription eyedrops (“Restasis”) for the improvement of tear break up time (“TBUT”), 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.

These results were presented today 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,” remarked Dr. Bloomenstein, O.D., FAAO, Director of Optometric Services, Schwartz Laser Eye Center, and a Principal Investigator for the SAHARA clinical trial. “Knowing we can achieve superior dry eye results with a procedure that also reduces concerns for daily prescription eyedrop patient compliance and adherence should make my colleagues in eyecare, 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. 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 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 that increased from a 1.5-second improvement from baseline at one week to a 2.5-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.
  • 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
TBUT Improvement from Baseline (seconds)
 
 TearCare Restasis P Value
Week 11.500.740.0001
Month 11.641.050.0055
Month 31.911.320.0080
Month 62.511.62

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