Patients treated with a single interventional eyelid procedure enabled by TearCare® technology after receiving Restasis® for the first six months of the trial realized clinically meaningful improvements in the signs and symptoms of dry eye disease through month twelve.
MENLO PARK, Calif., May 28, 2024 – Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences,” or the “Company”), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients’ lives, today announced the publication of the twelve-month results from the SAHARA trial.
Patients previously treated with Restasis® (cyclosporine ophthalmic emulsion 0.05%) prescription eyedrops (“Restasis”) had additional clinically meaningful improvements in the signs and symptoms of dry eye disease (“DED”) when crossed over to TearCare. These improvements persisted for six months through month twelve without continued Restasis use.
“Phase 2 of the RCT again demonstrates the clinical effectiveness of TearCare. It also shows that effectiveness appears to be the same whether or not a patient has had prior treatment with Restasis, demonstrating that similar results could be expected when TearCare is used as a primary or secondary treatment for DED,” said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences.
Phase 1 of the SAHARA RCT included 345 subjects at 19 sites in 11 states randomized 1:1 to either TearCare or Restasis1. In Phase 2 of the SAHARA RCT, 163 patients who had been randomized and treated with Restasis during phase 1 were crossed over to TearCare at the six-month visit and followed for six months through Month 12 of the study.
Data from the first six months of the SAHARA RCT demonstrated that TearCare, an interventional eyelid procedure for DED, was superior at all measured time points to twice daily use of Restasis for the improvement of tear break up time (“TBUT”), the trial’s primary dry eye signs endpoint and a key measure of tear stability1. TearCare was superior to Restasis in multiple other objective measures of dry eye, and demonstrated clinically meaningful improvements in several symptoms that matched or surpassed Restasis at all measured time points.
The aim of phase 2, undertaken in months six through twelve, was to demonstrate that cessation of Restasis followed by a single TearCare procedure would result in improved signs and symptoms for patients beyond what was achieved with six months of Restasis.
“These data demonstrate superior results with a dry eye treatment technology that is not reliant on patient adherence and supports the case for prioritizing interventional eye lid treatment over a prescription-based approach,” said Brandon Ayres, MD, Co-Director of the Cornea Fellowship Program at Wills Eye Hospital and a Principal Investigator for the SAHARA RCT.
SAHARA RCT Twelve-Month Phase 2 Results:
- The study reports TBUT improved by 1.1 seconds three months after cross-over to TearCare and improvement persisted (0.6 seconds) at month twelve, six months later. Both timepoints were statistically significantly better than the cross-over baseline (p<.001).
- Ocular Surface Disease Index (“OSDI”) had small, non-statistically significant decreases at three and six months after cessation of Restasis and a single TearCare treatment. In contrast, Symptoms Assessment in Dry Eye (“SANDE”) scores showed statistically significant improvement after the cross over to TearCare. Eye Dryness Scores (“EDS”) also showed improvement after cross-over at month 9 (p=.003), however, did not reach statistical significance at month 12.
- Statistically significant improvements in all other measures of signs following cross-over to TearCare were observed at month nine and month twelve (three and six months after TearCare treatment), except for STS (not measured at month nine), which was numerically better by an average 1.0 second, but not statistically better (p=0.08).
- Mean OSDI, SANDE, and EDS for the cross-over patients closely matched the means observed at month six for the TearCare treatment group.
- TBUT, meibomian gland secretion score (“MGSS”), meibomian glands yielding clear liquid score (“MGYCS”), corneal and conjunctival staining scores, and STS all improved and closely approximated the six-month TearCare values from phase 1. Meibomian glands yielding any liquid score (“MGYLS”) showed improvement (p<.001 vs. month six) but was intermediate between the six months values for Restasis and TearCare.
Table 1. Ocular signs outcomes.
| Ocular Symptom Parameters, mean (SD) | Study Baseline N=346 |
Month 6 Cross-over Visit N=326 |
Pa (vs. BL) |
Month 9 | Pa (vs. M6) |
Month 12 | Pa (vs. M6) |
| TBUT (sec) | 4.36 (1.2) | 5.6 (2.6) | <.001 | 6.6 (3.2) | <.001 | 6.1 (2.8) | <.001 |
| MGSS | 7.1 (3.2) | 13.3 (8.2) | <.001 | 17.4 (8.8) | <.001 | 16.1 (9.0) | <.001 |
| No. of MGYLS (n) | 1.2 (1.4) | 4.1 (4.0) | <.001 | 5.8 (4.7) | <.001 | 5.6 (4.8) | <.001 |
| No. of MGYCS (n) | 0.08 (0.38) | 0.76 (1.99) | <.001 | 1.3 (2.7) | <.001 | 1.0 (2.4) | .044 |
| Corneal staining score | 2.9 (2.7) | 2.0 (2.4) | <.001 | 1.5 (1.9) | .004 | 1.6 (2.2) | .002 |
| Conjunctival staining score | 3.6 (3.5) | 2.8 (3.2) | <.001 | 2.0 (2.5) | .001 | 1.9 (2.8) | <.001 |
| STS (mm) | 9.3 (3.1) | 11.0 (6.3) | ns, .075 | nm | – | 12.0 (7.2) | ns, .080b |
a Mann-Whitney rank sum test. b P<.001 vs Study baseline.
Month 9 and 12 visits are 3 and 6 months post-cross-over from CsA to TC. OD and OS measurements pooled.
Abbreviations: BL, baseline; M6, month 6; SD, standard deviation; TBUT, tear break-up time; MGSS, meibomian gland secretion score; MGYLS, meibomian glands yielding any liquid score; MGYCS, meibomian glands yielding clear liquid score; STS, Schirmer tear score; ns, not statistically significant; nm, not measured.
Table 1 shows the observed mean values for signs at the end of phase 2 of the study for the Restasis cross-over cohort.
As the SAHARA RCT continues into Phase 3, it will provide long-term 2-year data for the durability and procedural treatment effect of TearCare.
Authors and affiliations: Dr. Brandon D Ayres MD (Private Practice), Dr. Marc R Bloomenstein OD of Schwartz Laser Eye Center, Dr. Jennifer Loh MD of Loh Ophthalmology Associates, Dr. Thomas Chester OD of Cleveland Eye Clinic, Dr. Bobby Saenz OD MS of Rosenberg School of Optometry and Lasik San Antonio, Dr. Julio Echegoyen MD PhD of Gordon Schanzlin New Vision Institute, Dr. Shane R Kannarr OD of Kannarr Eye Care, Jaime E. Dickerson Jr., PhD of Sight Sciences and University of North Texas Health Science Center, and Tomasita Rodriguez of Sight Sciences.
Paper Reference: Ayers BD, Bloomenstein MR, Loh J, Chester T, Saenz B, Echegoyen J, Kannarr SR, Rodriguez TC, Dickerson JE Jr. Improved signs and symptoms of dry eye disease for Restasis® patients following a single TearCare® treatment: phase 2 of the SAHARA study. Clin Ophthalmol. 2024;18:1525-1534. doi: 10.2147/OPTH.S464379
