--- title: Sight Sciences Secures FDA Clearance for OMNI Ultra description: Sight Sciences receives FDA 510(k) clearance for OMNI Ultra, a next-generation implant-free MIGS system for primary open-angle glaucoma. image: https://visionexecutives.com/hubfs/AI-Generated%20Media/Images/OMNI%20Ultra%20Surgical%20System%20in%20Sterile%20Environment.png --- [Skip to content](https://visionexecutives.com/blog/sight-sciences-omni-ultra-fda-clearance#main-content) [![Vision Executives Logo](https://visionexecutives.com/hubfs/Color%20logo%20with%20white%20text.svg)](https://www.visionexecutives.com/) - [About](https://visionexecutives.com/about-us) - Recruitment Services Show submenu for Recruitment Services - [Retained Recruitment](https://visionexecutives.com/retained-recruitment) - [Contingency Recruitment](https://visionexecutives.com/contingency-recruitment) - [Our Candidates](https://visionexecutives.com/our-candidates) - [FREE Bad Hire Calculator](https://visionexecutives.com/bad-hire-calculator) - [FREE Job Survey](https://visionexecutives.com/free-job-survey) - Candidate Services Show submenu for Candidate Services - [Representing You](https://visionexecutives.com/representing-you) - [CV & LinkedIn Writing Service](https://visionexecutives.com/our-packages) - [Our Vacancies](https://visionexecutives.com/vacancies) - News & Insights Show submenu for News & Insights - [Latest News & Articles](https://visionexecutives.com/blog) - [Eyewear & Optics Salary Report](https://visionexecutives.com/eyewear-optical-industry-salary-report) - [Optometrist & Ophthalmologist Salary Report](https://visionexecutives.com/optometrist-ophthalmologist-salary-report) - [Contact](https://visionexecutives.com/contact-us) Open main navigation Close main navigation - [About](https://visionexecutives.com/about-us) - Recruitment Services Show submenu for Recruitment Services - [Retained Recruitment](https://visionexecutives.com/retained-recruitment) - [Contingency Recruitment](https://visionexecutives.com/contingency-recruitment) - [Our Candidates](https://visionexecutives.com/our-candidates) - [FREE Bad Hire Calculator](https://visionexecutives.com/bad-hire-calculator) - [FREE Job Survey](https://visionexecutives.com/free-job-survey) - Candidate Services Show submenu for Candidate Services - [Representing You](https://visionexecutives.com/representing-you) - [CV & LinkedIn Writing Service](https://visionexecutives.com/our-packages) - [Our Vacancies](https://visionexecutives.com/vacancies) - News & Insights Show submenu for News & Insights - [Latest News & Articles](https://visionexecutives.com/blog) - [Eyewear & Optics Salary Report](https://visionexecutives.com/eyewear-optical-industry-salary-report) - [Optometrist & Ophthalmologist Salary Report](https://visionexecutives.com/optometrist-ophthalmologist-salary-report) - [Contact](https://visionexecutives.com/contact-us) - [EYE-INTRO Login](https://vision-executives.i-intro.net/) [EYE-INTRO Login](https://vision-executives.i-intro.net/) # Sight Sciences Secures FDA Clearance for OMNI Ultra Aug 14, 2026, 3:51:39 PM [Vision Executives](https://visionexecutives.com/blog/author/vision-executives) Share: [facebook-f icon](http://www.facebook.com/share.php?u=https://visionexecutives.com/blog/sight-sciences-omni-ultra-fda-clearance) [linkedin-in icon](http://www.linkedin.com/shareArticle?mini=true&url=https://visionexecutives.com/blog/sight-sciences-omni-ultra-fda-clearance) [twitter icon](https://twitter.com/intent/tweet?url=https://visionexecutives.com/blog/sight-sciences-omni-ultra-fda-clearance) [pinterest-p icon](http://pinterest.com/pin/create/link/?url=https://visionexecutives.com/blog/sight-sciences-omni-ultra-fda-clearance) [envelope icon](mailto:?body=https://visionexecutives.com/blog/sight-sciences-omni-ultra-fda-clearance) ## The next-generation implant-free MIGS technology introduces single-pass circumferential canaloplasty, enhanced viscodilation control and greater procedural flexibility for glaucoma surgeons. Sight Sciences has received US Food and Drug Administration (FDA) 510(k) clearance for the OMNI® Ultra Surgical System, expanding its portfolio of implant-free technologies for minimally invasive glaucoma surgery. The handheld, single-use device is indicated for canaloplasty followed by trabeculotomy to reduce intraocular pressure in adults with primary open-angle glaucoma.OMNI Ultra builds on Sight Sciences’ established OMNI platform, introducing new capabilities designed to give ophthalmic surgeons greater control, precision and flexibility when treating the conventional aqueous outflow pathway. ## What is the OMNI Ultra Surgical System? OMNI Ultra is an implant-free minimally invasive glaucoma surgery (MIGS) system designed to address the three recognised areas of resistance within the eye’s conventional aqueous outflow pathway: - The trabecular meshwork - Schlemm’s canal - The collector channels Treatment is delivered through a single clear-corneal microincision, with no implant left inside the eye. The system combines canaloplasty, microcatheterisation and viscodilation of Schlemm’s canal, with trabeculotomy of the trabecular meshwork.OMNI Ultra can be used as a standalone glaucoma procedure or in combination with cataract surgery in adults with primary open-angle glaucoma. ## What does OMNI Ultra add to the platform? A key advancement of OMNI Ultra is its ability to perform circumferential canaloplasty in a single pass. Sight Sciences describes it as the first FDA-cleared MIGS device designed for single-pass circumferential canaloplasty. The device also incorporates TruSync™ Plus technology, which enables controlled viscodilation as the microcatheter advances and retracts through Schlemm’s canal. According to Sight Sciences, the principal features of OMNI Ultra include: - **Comprehensive implant-free treatment:** Targets all three recognised areas of conventional outflow resistance through a single clear-corneal microincision. - **Single-pass circumferential canaloplasty:** Enables a full canaloplasty without multiple passes around Schlemm’s canal. - **Controlled viscodilation:** TruSync Plus technology supports predictable delivery during both advancement and retraction of the catheter. - **Improved visualisation:** Enhanced catheter visibility helps surgeons assess and tailor treatment delivery. - **Greater treatment versatility:** Supports personalised procedures across a range of glaucoma severities and surgical settings. Together, these features are intended to improve procedural efficiency while maintaining the flexibility of the existing OMNI platform. ## Building on more than 350,000 OMNI procedures. OMNI Ultra is the latest addition to a platform used in more than 350,000 procedures worldwide, according to Sight Sciences. This figure includes OMNI, OMNI Edge and earlier OMNI platform devices shipped as of 30 June 2026. The company said the new system builds on the platform’s established safety profile, clinical effectiveness and ease of use, while adding enhanced procedural control and treatment precision. Paul Badawi, co-founder and chief executive officer of Sight Sciences, described the clearance as an important milestone in the company’s continued investment in implant-free glaucoma intervention. He said OMNI Ultra was designed to enhance control, efficiency and precision while preserving the simplicity and reliability surgeons expect from the platform. ## Why the clearance matters for glaucoma care. Primary open-angle glaucoma is commonly associated with increased resistance in the eye’s conventional aqueous outflow pathway, which can lead to elevated intraocular pressure. Minimally invasive glaucoma surgery (MIGS) has expanded treatment options between medication or laser therapy and more invasive surgical procedures. Implant-free approaches offer an alternative that restores outflow through the eye’s natural drainage system without leaving a permanent device. By combining canaloplasty and trabeculotomy in a single system, OMNI Ultra is designed to help surgeons address multiple points of outflow resistance through a comprehensive canal-based approach. Its use in both standalone procedures and combined cataract surgery may also increase its relevance across different clinical workflows and stages of glaucoma management. ## US launch planned for Q4 2026. Following FDA clearance, Sight Sciences is preparing for the commercial launch of OMNI Ultra in the United States. The company currently expects the system to become available in the fourth quarter of 2026. The clearance marks another step forward in implant-free MIGS innovation and reflects the ophthalmology sector’s ongoing shift toward earlier, more comprehensive and more personalised glaucoma treatment. For eye-care providers, the upcoming launch will be closely watched as surgeons evaluate how single-pass canaloplasty, controlled viscodilation and enhanced catheter visibility translate into real-world clinical practice.    ## Stay connected with Vision Executives. 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