Sight Sciences Announces Positive Results and Primary Endpoint Successfully Met in SAHARA, a Randomized Controlled Clinical Trial Comparing Interventional Eyelid Procedures Enabled by TearCare® Technology to Restasis¹ for the Treatment of Dry Eye
Dry eye has significant negative impact on visual function including reading, driving, workplace productivity, physical functioning, and quality of life, and creates a substantial burden to patients and society in general²
MENLO PARK, Calif., July 20, 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 six-month results from the SAHARA randomized controlled trial (RCT). The trial successfully met its primary endpoint and the data reported statistically significant improvements as compared to Restasis eye drops for the treatment of dry eye disease. These results will be presented in greater detail at the American Academy of Optometry’s annual meeting in October 2023.
SAHARA Phase I Results:
- The SAHARA trial achieved its primary six-month endpoint, demonstrating the superiority of interventional eyelid procedures enabled by TearCare over Restasis eyedrops in the improvement of tear break up time (TBUT), a key measure of aqueous retention, tear stability and the tear film’s ability to protect the ocular surface.
- The SAHARA trial also observed that procedures enabled by TearCare were non-inferior to Restasis eyedrops in Ocular Surface Disease Index (OSDI), which was the co-primary six-month endpoint.
- Throughout the study, interventional eyelid procedures with TearCare demonstrated clinically and statistically significant improvements of every endpoint and at every measurement interval: one week, one month, three months, and six months. Endpoints assessed include TBUT, meibomian gland score, corneal staining, and conjunctival staining. Symptoms endpoints include two commonly used patient-reported questionnaires: Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE).
“At each measurement interval over the initial six-month study period, subjects in the TearCare cohort exhibited statistically significant improvement in all key signs and symptoms,” remarked Brandon Ayres, MD, FAAO, Co-Director Cornea Fellowship Program, Wills Eye Hospital and a Principal Investigator of Sahara. “As we hypothesized, the data from the SAHARA trial suggests that interventional eyelid procedures enabled by TearCare technology help directly address the root cause of MGD and were more effective than topical Restasis eyedrops in treating dry eye on an aggregate basis across the endpoints measured in the SAHARA trial. TearCare patients in the SAHARA trial benefitted from improved function of obstructed and diseased meibomian glands and experienced rapid improvement in dry eye symptoms. The results from SAHARA support and build on the results from prior TearCare technology trials. This landmark “device vs. drug” trial shows we should change how we treat meibomian gland disease and dry eye in the future.”
“We are extremely pleased with the successful 6-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 Restasis,” said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences. “We focus on developing interventional technologies and procedures that can comprehensively address the underlying causes of eye disease and this is evident in both our OMNI® technology for primary open angle glaucoma as well as our TearCare technology for meibomian gland disease. SAHARA demonstrates the rigor we embrace in designing clinical trials to establish the clinical value of our products and procedures.”
TearCare is intended to help restore healthy function to diseased meibomian glands by removing obstructions interfering with meibum production and outflow. SAHARA is the first of its kind head-to-head, “device versus drug” RCT designed to compare the effectiveness of interventional eyelid procedures enabled by TearCare to twice daily Restasis prescription eyedrops (cyclosporine ophthalmic emulsion, 0.05%). In this trial, 345 subjects at 25 sites in 14 states were randomized 1:1 between TearCare and Restasis groups. To reduce the potential for bias, physicians evaluating patients were masked regarding subject treatment groups.
SAHARA was designed to challenge existing treatment paradigms by focusing physicians’ attention on restorative procedures that address the underlying cause of meibomian gland disease (MGD) and demonstrate the clinical benefits of procedural dry eye intervention compared to prescription dry eye eyedrops.
Over 17 million Americans are diagnosed with dry eye disease and studies have shown that MGD is associated with up to 86% of dry eye disease³. Currently, over the counter and prescription eyedrops are the dominant treatment for dry eye with costs to payors and patients exceeding $2 billion annually⁴. Eyedrops do not address obstructed meibomian glands, the root underlying cause of MGD. Sight Sciences designed its TearCare technology and its comprehensive interventional eyelid procedure to safely and effectively treat the underlying obstructive causes of MGD.
An abstract of Phase 1 results from SAHARA has been accepted by the American Academy of Optometry for presentation at its annual meeting in October. Sight Sciences plans to submit the findings from SAHARA for publication in peer-reviewed journals in the coming months. In the next phase of the SAHARA study, 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. Final results from SAHARA are expected by 2025.
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 is a trademark of Sight Sciences.
© 2023 Sight Sciences. All rights reserved.
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 or during the earnings call 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 disclosure, anticipated SAHARA patient follow-up, how the SAHARA trial shows we should change how we treat meibomian gland disease and dry eye in the future, and estimated timing for disclosure of final SAHARA trial results. 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.
|1 Restasis® is a trademark of Allergan™ an AbbVie company |
2 Miljanovic B. et. al., Impact of Dry Eye Syndrome on Vision-related Quality of Life. Am. J. Ophthalmol. 2007; 143(3): 409-415
3 Lemp MA, Crews LA, Bron AJ, et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31(5):472-478.
4 Market Scope 2022 Dry Eye Products Report.