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.