A Meta-Analysis of 22 Studies, and Data from the IRIS® Registry Highlighting Clinical Outcomes in Real-World Clinical Practice, Demonstrates Significant, Long-Term IOP Reduction and Medication Reduction with the OMNI® Surgical System
MENLO PARK, Calif., Feb. 24, 2025 (GLOBE NEWSWIRE) -- 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 eye care and improve patients' lives, today announced that multiple presentations on the OMNI® Surgical System ("OMNI") will be presented at the 2025 American Glaucoma Society ("AGS") Annual Meeting in Washington, D.C. from February 26 to March 1. These presentations will showcase new data on the clinical effectiveness and safety of OMNI across diverse patient populations.
The data reinforces the safety and clinical effectiveness of OMNI in treating primary open-angle glaucoma in adult patients. Several of the presentations will feature data curated by Verana Health®, a digital health company dedicated to revolutionizing patient care and clinical research through real-world data (RWD). The data stems from a partnership between Verana Health and the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight), which is one of the largest specialty society clinical data registries in all of medicine and the first comprehensive eye disease clinical registry in the United States.
"This new data from the IRIS Registry provides valuable real-world insights into the performance of OMNI across diverse patient populations and disease severities," said Leon W. Herndon Jr., MD, Duke University. "For example, our study showed that MIGS, including OMNI, when combined with cataract surgery in Black patients, resulted in clinically and statistically significant reductions in IOP through 24 months as well as statistically significant reductions in medication through 36 months."
Results of a systematic literature review and meta-analysis of clinical, economic, and humanistic evidence of the OMNI Surgical System and its predecessors for the treatment of open-angle glaucoma ("OAG") will also be presented.
"Our review and analysis highlighted the accumulation of data demonstrating the favorable efficacy and safety profiles of OMNI and its predecessors over periods up to 36 months," said Sameh Mosaed, MD, Professor and Chief of Glaucoma Division at the Gavin Herbert Eye Institute of the University of California, Irvine. "These results position OMNI as a beneficial long-term treatment option for patients with OAG."
"The breadth of clinical data presented at AGS highlights the long-term safety and effectiveness of OMNI in a wide range of glaucoma patients, including diverse patient populations as well as patients with different disease severities," said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences. "These new findings reflect our commitment to advancing glaucoma care and providing physicians with effective treatment options that ultimately benefit patients by reducing their dependence on medications and improving their quality of life."
Launched in 2014, the IRIS Registry has amassed over 851 million patient encounters and 80 million unique de-identified patients from more than 30 electronic health records ("EHRs") and 15,000 ophthalmologists and other eye care professionals across the U.S.
OMNI enables an implant-free, ab interno minimally invasive glaucoma surgery ("MIGS") procedure intended to restore aqueous outflow of glaucomatous eyes by addressing the three areas of outflow resistance associated with glaucoma.
Presentations featuring OMNI data at AGS include:
Thursday, February 27, 8:00 AM – 9:00 AM EST:
Systematic Review and Meta-analysis of Clinical, Economic, and Humanistic Evidence for the Canaloplasty/Trabeculotomy Surgical System (CTSS) in Open-Angle Glaucoma Treatment
Presenting author: Sameh Mosaed, MD, UC Irvine Location: Ambassador Room – This meta-analysis of 22 unique studies, including 2,379 eyes, concluded that OMNI and predecessor devices (CTSS) consistently reduced intraocular pressure ("IOP") and decreased the need for medication up to 36 months. The data also showed that both standalone and combined treatment effectively reduced IOP and medication use for up to 24 months.
Thursday, February 27, 5:11 PM – 5:19 PM EST:
What's your sign? GEMINI
Presenting author: Mona Kaleem, MD, Johns Hopkins School of Medicine Location: Regency Ballroom – We are pleased that AGS has recognized our prospective GEMINI study as a landmark trial in glaucoma. This presentation is part of the Surgery Day Section 5: AGS/ASCRS Symposium "From Sea to Shining Sea" - Landmark Trials in the MIGS Revolution
Friday, February 28, 8:00 AM – 9:00 AM EST:
Standalone Canaloplasty and Trabeculotomy Outcomes for Phakic and Pseudophakic Eyes: An American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) Analysis
Presenting author: Mark Pyfer, MD, Northern Ophthalmic Associates Location: Ambassador Room – This study demonstrated that OMNI provided clinically and statistically significant IOP reductions in both phakic and pseudophakic eyes, with an increase in medication-free patients at 36 months.
Ab Interno Minimally Invasive Glaucoma Surgery Effectiveness in Black Patients: IRIS® Registry Study
Presenting author: Leon W. Herndon Jr., MD, Duke University Location: Ambassador Room – This study showed that MIGS procedures, including OMNI, combined with cataract surgery in Black patients, resulted in significant reductions in IOP and medication use.
36-Month Outcomes from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight): Standalone Canaloplasty and Trabeculotomy in Eyes with Mild, Moderate, and Severe Primary Open-Angle Glaucoma (POAG)
Presenting author: Christine Funke, MD, Barnet Dulaney Perkin Eye Center Location: Ambassador Room – This study demonstrated clinically and statistically significant IOP reductions across all glaucoma severity levels (mild, moderate, and severe) following standalone canaloplasty and trabeculotomy using the OMNI Surgical System.
Additionally, Sight Sciences will host a lunch symposium where leading experts will explore a pivotal question: Will You Wait or Act? The Crucial Choice in Combating Glaucoma with Interventional Treatment.
Date and Time:
Saturday, March 1, 2025
1:00 PM – 2:15 PM EST
Location:
AGS Diamond Theater
Faculty:
Ike Ahmed, MD; John A. Moran Eye Center, Salt Lake City, UT
Reay H. Brown, MD; Atlanta Ophthalmology Associates, Atlanta, GA
Christine M. Funke, MD; Barnet Dulaney Perkins, Phoenix, AZ
For hands-on demos and more events and information, stop by booth #48 during exhibit hours.
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 is an implant-free glaucoma surgery technology (i) indicated in the United States to reduce intraocular pressure in adult patients with primary open-angle glaucoma; and (ii) 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 Instrument 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 dysfunction ("MGD") when used in conjunction with manual expression of the meibomian glands, enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease. Visit www.sightsciences.com for more information.
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. Visit www.omnisurgical.com/ifu to access the instructions for use, warnings, precautions, and adverse event information.
About Verana Health Verana Health® is a digital health company revolutionizing patient care and clinical research by utilizing physician expertise and artificial intelligence to unlock the true potential of real-world data. With exclusive access to the world's largest patient data sources in ophthalmology, urology, and neurology, Verana Health is powering real-world evidence generation. Clinicians utilize these insights to improve the quality of care and quality of life for patients, and life sciences companies rely on the insights to accelerate the development of new therapies. For more information, visit www.veranahealth.com.
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. IRIS is a registered trademark of the American Academy of Ophthalmology. Verana Health is a registered trademark of Verana Health.
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, without limitation statements regarding presentation of new real-world data on OMNI's clinical effectiveness and safety across diverse patient populations, anticipated presentation of clinical data and studies at AGS, and positioning of OMNI as a beneficial long-term treatment option for patients with OAG. 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.
