Sight Sciences 获得 FDA 510(k) 批准其 OMNI Ultra 青光眼手术系统

MENLO PARK, Calif., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative interventional technologies intended to transform eye care and improve patients' lives, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the OMNI® Ultra Surgical System (OMNI Ultra) for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG).
Key Features of OMNI Ultra
- Comprehensive implant-free intervention: Addresses all three known areas of outflow resistance through a single, clear corneal microincision without leaving an implant behind.
- Complete and efficient canaloplasty: The first FDA cleared minimally invasive glaucoma surgery (MIGS) device for circumferential canaloplasty in a single pass.
- TruSync™ Plus technology: Provides enhanced control, precision, and surgeon confidence of predictable viscodilation on advancement and retraction throughout the canaloplasty procedure.
- Expanded treatment versatility: Preserves the flexibility surgeons value in the OMNI platform, enabling personalized treatment across varying disease severities and surgical settings while supporting enhanced catheter visualization to help surgeons confidently assess and tailor treatment delivery.
Dr. Arkadiy Yadgarov, who participated in both the design enhancements and clinical evaluation of OMNI Ultra, commented, "OMNI Ultra embodies everything surgeons value about Sight Sciences, their commitment to partnering closely with surgeons to advance the interventional glaucoma category on behalf of patients, and their leading implant-free technology platform with OMNI. I really enjoyed working closely with the Sight team over the past several years and providing my feedback to further advance OMNI, which has become an integral part of my glaucoma treatment paradigm. The system's enhanced design that includes a full canaloplasty in a single pass and TruSync Plus technology for automatic and controlled viscodilation upon microcatheter advancement and retraction represents the type of thoughtful innovation that I believe will resonate with surgeons moving forward. OMNI Ultra will allow surgeons to perform comprehensive and customizable outflow procedures with confidence and provides them with the flexibility they desire across a broad range of glaucoma patients in concomitant cataract surgery and standalone cases.”
This next-generation technology is the newest addition to the Company's OMNI product portfolio. OMNI Ultra represents the latest evolution of the proven OMNI platform and builds upon Sight Sciences' commitment to advancing implant-free, comprehensive MIGS. The system was designed to provide surgeons with enhanced procedural control and versatility while maintaining the trusted safety profile, clinical effectiveness, and ease of use that have made OMNI the leading implant-free MIGS technology.
Like previous versions of the OMNI Surgical System, OMNI Ultra is designed to reduce IOP by addressing all three known areas of resistance within the conventional aqueous outflow pathway: the trabecular meshwork, the Schlemm's canal, and the collector channels. The technology can be used as a standalone procedure or in combination with cataract surgery in adult patients with primary open-angle glaucoma.
"The FDA clearance of OMNI Ultra marks an important milestone reflecting our continued investment and meaningful innovation in our mission to provide surgeons with the most comprehensive and versatile implant-free glaucoma interventional technologies available," said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences. "As glaucoma continues to be the leading cause of irreversible blindness, we remain committed to developing technologies that help surgeons intervene earlier and more comprehensively. OMNI has transformed the canal-based MIGS category through its ability to address the complete conventional outflow pathway. With OMNI Ultra, we’re building on the proven OMNI platform with enhanced control, procedural efficiency, and treatment precision, while maintaining the simplicity, reliability and efficacy surgeons trust."
The OMNI technology platform is supported by extensive clinical evidence, including prospective, real-world, and long-term studies demonstrating meaningful reductions in IOP and medication burden. With more than 350,000 procedures performed worldwide1, the OMNI technology platform has become a trusted choice for surgeons performing comprehensive canal-based MIGS.
Following recent FDA clearance, the Company is focused on preparing for the U.S. commercial launch of OMNI Ultra, which remains on track for the fourth quarter of 2026.
About the OMNI Ultra Surgical System
The OMNI® Ultra Surgical System is a handheld, single-use therapeutic device for MIGS. The technology is designed to enable comprehensive intervention within the eye's conventional aqueous outflow pathway through canaloplasty and trabeculotomy, addressing the trabecular meshwork, the Schlemm's canal, and the collector channels through a single clear corneal microincision.
The OMNI Ultra Surgical System is indicated for canaloplasty (microcatheterization and viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of the trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
For complete indications for use, warnings, precautions, and adverse event information, visit www.sightsciences.com.
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. TruSync is a trademark of Sight Sciences.
© 2026 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, without limitation, statements regarding the commercialization, market adoption, clinical utilization, physician training, and performance of the Company's OMNI® Ultra Surgical System, as well as the anticipated timing of its commercial launch. 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 Estimate based on units of OMNI®, OMNI® Edge, and predecessor OMNI platform devices shipped as of June 30, 2026.
Media contact:
pr@sightsciences.com
Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
investor.relations@sightsciences.com