FDA Clears Sight Sciences’ OMNI Ultra Surgical System

Sight Sciences revealed that it’s obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its OMNI Ultra surgical system for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG).

OMNI Ultra provides an implant-free intervention that addresses all three known areas of outflow resistance through a single clear corneal microincision. It is the first FDA-cleared minimally invasive glaucoma surgery (MIGS) device to perform circumferential canaloplasty in a single pass, according to the Menlo Park, Calif.-based company.

TruSync Plus technology is designed to provide greater control and precision during viscodilation on both advancement and retraction. The system also supports personalized treatment across varying disease severities and surgical settings, with enhanced catheter visualization to help surgeons assess and tailor treatment delivery.

OMNI Ultra is the latest addition to Sight Sciences’ OMNI portfolio and builds on the company’s implant-free MIGS platform. The system is designed to provide greater procedural control and versatility while maintaining the platform’s established safety, clinical performance, and ease of use.

Like earlier OMNI systems, OMNI Ultra is designed to reduce intraocular pressure (IOP) by addressing resistance in the trabecular meshwork, Schlemm’s canal, and collector channels. It can be used as a standalone procedure or with cataract surgery in adults with primary open-angle glaucoma.

The company intends to commercially launch the surgical system in the U.S. in Q4 of this year.

Comments from Sight Sciences and clinicians

Dr. Arkadiy Yadgarov, participant in OMNI Ultra’s design enhancements and clinical evaluation: “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.”

Paul Badawi, co-founder and CEO, Sight Sciences: “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. 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.”