Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company, 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).
In a 24-month prospective study, Omni reduced intraocular eye pressure (IOP) by an average of 10.6 mmHg. A subgroup analysis found that Omni significantly reduced IOP for up to three years, regardless of lens status or disease severity.
The device addresses all three known areas of outflow resistance through a single, clear corneal microincision without leaving an implant behind and is the first FDA-cleared minimally invasive glaucoma surgery (MIGS) device for circumferential canaloplasty in a single pass, the company said in a news release.
The Omni Ultra features TruSync Plus technology, which provides enhanced control, precision and surgeon confidence of predictable viscodilation on advancement and retraction throughout the canaloplasty procedure, Sight Sciences said.
“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,” Arkadiy Yadgarov, who participated in both the design enhancements and clinical evaluation of Omni Ultra, said in a news release, “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.”
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 CEO 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.”
The Omni technology platform is supported by clinical evidence, including prospective, real-world and long-term studies demonstrating meaningful reductions in IOP and medication burden. It has been used to perform more than 350,000 procedures worldwide, Sight Sciences said.
Following recent FDA clearance, the company is focused on preparing for the U.S. commercial launch of Omni Ultra, which remains on track for the fourth quarter of 2026.
Sight Sciences reported revenue of $18.3 million for its Interventional Glaucoma segment in the first quarter ended Match 31, 2026, which includes Omni. This was a 7% increase compared to Q1 2025.
