Sight Sciences Announces the Publication of the 24-Month Results of the SAHARA RCT Demonstrating the Durability of the TearCare® Procedure for the Treatment of Dry Eye Disease

Rhea-AI Summary

Sight Sciences (Nasdaq: SGHT) announced the publication of 24-month results from Stage 3 of the SAHARA randomized controlled trial for its TearCare® System in treating dry eye disease. The study demonstrated significant durability, with 66% of participants requiring no additional treatment beyond the initial two treatments at baseline and Month 5.

The trial showed statistically significant improvements in all measured parameters including tear breakup time, meibomian gland secretion, and patient symptom scores. Key metrics remained improved through the 24-month period, with tear breakup time improving from 4.41 seconds at baseline to 6.29-7.13 seconds, and meibomian gland secretion scores increasing from 7.26 to 18.95.

Positive

• Long-term durability demonstrated with 66% of patients requiring no additional treatment beyond initial two treatments
• Statistically significant improvements maintained in all signs and symptoms through 24 months
• 92% probability of remaining retreatment-free for 6 months after initial treatments
• Previously demonstrated superiority over Restasis® prescription eyedrops for tear breakup time

Negative

• 34% of patients required additional treatments during the study period
• Some patients needed up to four treatments over the 24-month period

Insights

Medical Device Specialist

SGHT's TearCare demonstrates 24-month durability in treating dry eye disease with minimal treatments needed, strengthening its clinical evidence base.

The 24-month results from Sight Sciences' SAHARA randomized controlled trial provide compelling evidence for the long-term efficacy of the TearCare System in treating dry eye disease (DED). The data reveals remarkable durability – 66% of participants required only two treatments (at baseline and month 5) to maintain significant improvements throughout the entire 24-month study period. This represents a potential paradigm shift in DED management, which typically requires daily medication administration.

The trial showed statistically significant improvements across all key metrics including tear breakup time (increasing from 4.41 seconds at baseline to 6.29-7.13 seconds), meibomian gland secretion score (improving from 7.26 to sustained levels of 17.68-18.95), and patient-reported outcomes using standard assessment tools (OSDI, SANDE, and EDS) – all maintaining significance at p<0.0001 throughout the study period.

What's particularly notable is the retreatment-free survival probability of 92% at 6 months and the median retreatment time of 7 months for those needing additional treatment. For a chronic condition like DED, achieving sustained relief with just 1-2 treatments per year represents a substantial improvement over daily prescription eyedrops.

Previous stages of the SAHARA trial had already demonstrated TearCare's superiority over Restasis (cyclosporine ophthalmic emulsion 0.05%), a standard pharmaceutical treatment. This final stage validates the device's long-term efficacy, providing Sight Sciences with robust clinical evidence to support adoption and potentially influence reimbursement decisions for this interventional approach to dry eye management.

Mean signs and symptoms for participants in Stage 3 of the SAHARA trial remained statistically significantly better than study baseline at all time points measured up to 24 months

MENLO PARK, Calif., July 29, 2025 (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 that the manuscript detailing 24-month results from Stage 3 of the SAHARA randomized controlled trial (RCT) has been published ahead of print (PAP) by Optometry and Vision Science (Official Journal of the American Academy of Optometry) and is available online in pre-publication format.

All mean signs and symptoms remained statistically significantly better than the study baseline at all time points measured through the end of the study at 24 months. The majority (66%) of participants who received treatment for dry eye disease (DED) with the TearCare^® System (TearCare) at baseline and again at Month 5 required no additional treatment based on pre-defined retreatment criteria.

“These results demonstrate the durability, repeatability, and significant clinical benefits of treatment with TearCare in a landmark device versus drug RCT,” said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences. “This 24-month endpoint adds to the successful clinical trial results from the previous two stages of the SAHARA trial as well as numerous other studies, expanding a robust body of research evidencing both the effectiveness and durability of interventional dry eye therapy with TearCare. We were pleased to see the 24-month SAHARA RCT data confirm that participants achieved and maintained clinically significant improvements in all signs and symptoms of dry eye disease with one to two TearCare treatments per year.”

“TearCare is delivering something truly rare in dry eye care — relief that’s immediate, powerful, repeatable, and long-lasting,” said lead author John Hovanesian, MD. “Studies of this scale and rigor are uncommon in ocular surface disease, and our findings show that just two TearCare treatments within five months can result in meaningful, lasting improvements for up to two years—a significant step forward for patients living with dry eye disease.”

SAHARA RCT 24-Month Stage 3 Results:

• Tear breakup time (TBUT) remained statistically significantly better than study baseline for all subjects through Month 24 at all timepoints measured with means ranging from 6.29 to 7.13 seconds compared to the baseline of 4.41 seconds (all p<.0001).
• Meibum quality and quantity as measured by Meibomian Gland Secretion Score (MGSS) showed that the improvement from baseline observed at Month 6 following two TearCare treatments, 7.26 to 18.95, was maintained through 24 months for all subjects (means ranging from 17.68 to 18.95, p<.0001 at all timepoints measured versus baseline).
• The number of meibomian glands yielding any liquid (MGYAL) and number of glands yielding clear liquid (MGYCL) also showed clinically meaningful and statistically significant improvement at Month 6 which was sustained throughout the 24-month follow-up period at all timepoints measured, as did anesthetized Shirmer tear scores (STS) as well as conjunctival and corneal staining scores.
• Subject symptoms as assessed by Ocular Surface Disease Index (OSDI), symptom assessment in dry eye (SANDE) and eye dryness score (EDS) for all subjects remained near the values at Month 6 (OSDI 31.9, SANDE 40.2, EDS 39.9) and statistically significantly better than study baseline (OSDI 50.3, SANDE 66.8, EDS 65.1) at all follow-up timepoints measured (p<.0001).
• The study authors suggest that improvements in OSDI, SANDE, and EDS are of particular importance as they represent direct patient feedback about how their eyes feel and how DED is affecting their lives.
• Results from the first 6 months of the SAHARA RCT demonstrated that interventional eyelid procedures enabled by TearCare were superior to twice daily use of Restasis® (cyclosporine ophthalmic emulsion 0.05%) prescription eyedrops for the improvement of TBUT, the trial’s primary dry eye signs endpoint and a key measure of tear stability¹. In Stage 2 of the SAHARA RCT, 163 participants who had been randomized and treated with Restasis during Stage 1 were crossed over to TearCare treatment at the 6-month visit. After a single TearCare treatment and discontinuing Restasis, these participants realized additional clinically meaningful improvements in the signs and symptoms of dry eye disease through month 12².

The third and final stage of the SAHARA trial investigated the durability of treatment effect and retreatment interval over 24 months. Participants who were randomized to TearCare treatment in Stage 1, receiving treatment at baseline and Month 5, were followed for 19 months after the second treatment. Ocular signs of TBUT and MGSS as well as symptoms including OSDI were assessed at Months 6, 9, 12, 15, 18 and 24. Retreatment was permitted when TBUT was within 2 seconds of pre-treatment baseline and OSDI increased by 15 points from the previous visit.

For the overall group of 166 subjects that entered this final stage of the trial, all measures of signs and symptoms remained statistically significantly better than study baseline at all time points. Following the first two treatments at baseline and Month 5, 127 patients did not require additional TearCare treatment for the duration of the study, 32 patients underwent a third treatment, while 7 subjects had a fourth treatment. The median time for a first retreatment was 7 months for those retreated. The 6-month retreatment-free survival probability was 92%.

Authors and Affiliations: Dr. John Hovanesian MD of Harvard Eye Associates, 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, Tomasita C Rodriguez of Sight Sciences and Jaime E. Dickerson Jr., PhD of Sight Sciences and University of North Texas Health Science Center.

Paper Reference: Hovanesian, J; Ayres, BD; Bloomenstein, MR; Loh, J; Chester, T; Saenz, B; Echegoyen, J; Kannarr, SR; Rodriguez, T; Dickerson, J. Durability of the TearCare treatment effect in subjects with dry eye disease: Stage 3 of the Sahara randomized controlled trial. Optometry and Vision Science ():10.1097/OPX.0000000000002278, July 28, 2025. | DOI: 10.1097/OPX.0000000000002278

1. Ayres BD, Schachter S, Shen Lee B, et al. A randomized, controlled trial comparing TearCare^® and cyclosporine ophthalmic emulsion for the treatment of dry eye disease (SAHARA). Clin Ophthalmol. 2023;17:3925-3940.
2. Ayers BD, Bloomenstein MR, Loh J, et al. 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

About Sight Sciences

Sight Sciences is an eyecare technology company focused on developing and commercializing innovative and interventional solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI^® Surgical System and OMNI^® Edge Surgical System are implant-free, minimally invasive glaucoma surgery technologies indicated in the United States to reduce intraocular pressure in adult patients with primary open-angle glaucoma. The OMNI Surgical System is CE Marked for the catheterization and transluminal viscodilation of Schlemm’s canal and cutting of the trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma. Glaucoma is the world’s leading cause of irreversible blindness. The SION^® Surgical System is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. The Company’s TearCare^® System is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland disease (MGD), enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease.

Visit www.sightsciences.com for more information. 

Sight Sciences and TearCare are trademarks of Sight Sciences registered in the United States. OMNI and SION are trademarks of Sight Sciences registered in the United States, European Union and other territories.
Restasis is a registered trademark of Allergan, an AbbVie company.

© 2025 Sight Sciences. All rights reserved.

Forward-Looking Statements
This press release, together with other statements and information publicly disseminated by the Company, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements include potential benefits of a treatment with the TearCare System, including evidence that two TearCare treatments within five months can result in meaningful, lasting improvements for up to two years. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although we believe that these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our business, results of operations and financial condition and could cause actual results to differ materially from those expressed in the forward-looking statements. These forward-looking statements are subject to and involve numerous risks, uncertainties and assumptions, including those discussed under the caption “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, as may be updated from time to time in subsequent filings, and you should not place undue reliance on these statements. These cautionary statements are made only as of the date of this press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Media contact
pr@SightSciences.com

Investor contact
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com

FAQ

What were the key findings of SGHT's SAHARA trial for TearCare at 24 months?

The trial showed that 66% of patients maintained improvements with just two initial TearCare treatments, demonstrating statistically significant improvements in all dry eye disease signs and symptoms through 24 months.

How does TearCare's effectiveness compare to Restasis for dry eye treatment?

Earlier stages of the SAHARA trial showed TearCare was superior to Restasis for improving tear breakup time, a key measure of tear stability.

How long do TearCare treatment effects last for dry eye disease?

The study showed that most patients (66%) maintained improvements for up to 24 months with just two initial treatments, with a 92% probability of remaining retreatment-free for 6 months.

What improvements in dry eye symptoms were seen with TearCare in the SAHARA trial?

Patients showed significant improvements in tear breakup time (from 4.41 to 6.29-7.13 seconds), meibomian gland secretion (7.26 to 18.95), and maintained better symptom scores throughout the 24-month period.

How many TearCare treatments did patients need over the 24-month SAHARA study?

66% of patients needed only two initial treatments, while 32 patients required a third treatment and 7 patients needed a fourth treatment over the 24-month period.