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
- TearCare technology demonstrated superior results compared to Restasis eyedrops for the treatment of dry eye disease, with statistically significant improvements in tear break up time and other objective signs of dry eye. TearCare offers an alternative treatment option that reduces concerns for daily prescription eyedrop patient compliance and adherence.
- None.
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 1 | 1.50 | 0.74 | 0.0001 |
| Month 1 | 1.64 | 1.05 | 0.0055 |
| Month 3 | 1.91 | 1.32 | 0.0080 |
| Month 6 | 2.51 | 1.62 | <0.0001 |
| OSDI Score Improvement from Baseline * | ||
| TearCare | Restasis | |
| Week 1 | 15.93 | 15.86 |
| Month 1 | 16.47 | 16.77 |
| Month 3 | 15.82 | 18.81 |
| Month 6 | 19.76 | 19.71 |
* At all time points, both groups significantly improved from baseline, P<0.0001
“We are extremely pleased with the successful six-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 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.
About Sight Sciences
Sight Sciences is an eyecare technology company focused on developing and commercializing innovative 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 is a minimally invasive glaucoma surgery (“MIGS”) technology indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (“POAG”), the world’s leading cause of irreversible blindness. The Company’s TearCare System technology is 510(k) cleared for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (“MGD”) when used in conjunction with manual expression of the meibomian glands, enabling office-based clearance of gland obstructions by physicians to address the leading cause of dry eye disease. The Company’s SION™ Surgical Instrument is a manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork.
For more information, visit www.sightsciences.com.
OMNI and TearCare are registered trademarks of Sight Sciences.
SION and TCOR are trademarks of Sight Sciences.
Restasis is a trademark of Allergan, an AbbVie company.
© 2023 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 information concerning timing of SAHARA trial clinical data publication; rethinking options for the treatment of dry eye; knowledge that the achievement through the use of TearCare technology of superior dry eye results via an in-office procedure that addresses medication usage compliance should cause eyecare professionals and insurance providers to consider providing patients with access to TearCare as an efficacious and durable interventional dry eye treatment; and, conduct of Phase II of the SAHARA study. 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.
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FAQ
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