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Sight Sciences, Inc, an eyecare technology company focused on developing and commercializing innovative interventional technologies intended to transform eye care and improve patients' lives, announced US 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).
New system expands the company’s leadership in interventional glaucoma with the first US FDA cleared MIGS device for single pass canaloplasty with TruSync Plus innovation.
Key features of OMNI Ultra are: 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 US commercial launch of OMNI Ultra, which remains on track for the fourth quarter of 2026.
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.
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