Menlo Park, California – August 4, 2026
Sight Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OMNI® Ultra Surgical System, the company’s next-generation minimally invasive glaucoma surgery (MIGS) technology designed to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG). The newly cleared system introduces the first FDA-cleared MIGS device capable of performing circumferential canaloplasty in a single pass, enhanced by the company’s proprietary TruSync™ Plus technology for controlled viscodilation throughout the procedure. Building upon the clinically proven OMNI platform, the OMNI Ultra Surgical System expands Sight Sciences’ leadership in implant-free glaucoma intervention, providing ophthalmic surgeons with improved procedural precision, enhanced versatility, and greater efficiency while maintaining the safety and effectiveness associated with previous OMNI technologies. The company is preparing for a U.S. commercial launch in the fourth quarter of 2026, further strengthening its portfolio of innovative ophthalmic surgical solutions.
FDA Clearance Advances Implant-Free Glaucoma Surgery
The OMNI® Ultra Surgical System represents the latest advancement in Sight Sciences’ implant-free glaucoma technology platform, specifically engineered to provide comprehensive intervention across all three areas of conventional aqueous outflow resistance through a single clear corneal microincision. The system combines canaloplasty and trabeculotomy while introducing single-pass circumferential canaloplasty, enabling surgeons to complete the procedure more efficiently than previous technologies. Integrated TruSync™ Plus innovation delivers automatic, controlled viscodilation during both advancement and retraction of the microcatheter, improving procedural consistency, catheter control and surgeon confidence. Designed to preserve the flexibility that physicians value within the OMNI platform, the system also offers enhanced catheter visualization, allowing surgeons to customize treatment according to disease severity and individual patient anatomy. These enhancements further strengthen the role of minimally invasive glaucoma surgery (MIGS) in the management of patients with primary open-angle glaucoma.
Next-Generation Technology Builds on Proven Clinical Platform
The newly cleared OMNI Ultra Surgical System builds upon the success of the original OMNI platform, which has become one of the leading implant-free MIGS technologies worldwide. Like previous OMNI systems, OMNI Ultra targets all three major sources of resistance within the eye’s conventional aqueous outflow pathway, including the trabecular meshwork, Schlemm’s canal, and collector channels, helping lower intraocular pressure while preserving natural anatomy. The device can be performed as a standalone procedure or in combination with cataract surgery, providing physicians with greater flexibility when treating patients with glaucoma. Supported by extensive prospective, long-term and real-world clinical evidence, the OMNI platform has demonstrated meaningful reductions in intraocular pressure and dependence on glaucoma medications. With more than 350,000 procedures performed worldwide, the technology has established a strong reputation among ophthalmic surgeons seeking effective implant-free glaucoma treatment options.
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Commercial Launch Supports Future Ophthalmic Innovation
Following FDA 510(k) clearance, Sight Sciences is preparing for the commercial introduction of OMNI Ultra in the United States during the fourth quarter of 2026, supporting its broader mission of transforming glaucoma care through minimally invasive innovation. The company continues investing in advanced ophthalmic technologies that address the underlying causes of chronic eye diseases while enabling earlier intervention and improved patient outcomes. As glaucoma remains one of the world’s leading causes of irreversible blindness, demand continues to grow for surgical solutions capable of lowering intraocular pressure without implanting permanent devices. By combining single-pass canaloplasty, enhanced treatment precision and implant-free technology, the OMNI Ultra Surgical System further strengthens Sight Sciences’ position within the expanding ophthalmic medical device market. The FDA clearance marks an important milestone in the company’s ongoing commitment to delivering next-generation glaucoma solutions that improve both surgeon experience and patient care.
Source: Sight Sciences press release
