Sight Sciences' newest MIGS device gains FDA clearance for single-pass canaloplasty and trabeculotomy in open-angle glaucoma.
Sight Sciences, Inc. has received US Food and Drug Administration 510(k) clearance for the OMNI Ultra Surgical System, a next-generation version of its implant-free
“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,” Paul Badawi, co-founder and chief executive officer of Sight Sciences, said in a statement announcing the clearance.¹
KEY FACTS
OMNI Ultra was cleared through the FDA's 510(k) premarket notification pathway, which permits marketing of a device shown to be substantially equivalent to a legally marketed predicate—in this case, earlier OMNI Surgical System models.¹ The device is intended to open the eye’s natural drainage pathway in a single procedure, combining catheter-based dilation of the canal with a separate cutting step at the trabecular meshwork, and is delivered through one small corneal incision without leaving material behind in the eye.¹
Sight Sciences describes the newly added TruSync Plus feature as an automated control mechanism that regulates how much viscoelastic fluid is delivered as the catheter moves through the canal, a function the company says was previously more dependent on manual technique.¹ The company also notes improvements to intraoperative visualization of the catheter tip. Sight Sciences has not published device-specific clinical outcomes data for OMNI Ultra; clearance was based on substantial equivalence rather than a new pivotal trial.¹
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma accounting for the largest share of cases.² Standard management emphasizes IOP lowering through topical medications, laser trabeculoplasty, or incisional and minimally invasive surgery, with MIGS procedures increasingly used to reduce medication burden while preserving conjunctival tissue for potential future filtration surgery.² Devices in this category work by relieving resistance at one or more points along the eye’s conventional outflow pathway, an anatomic route that includes the trabecular meshwork and the venous collector system downstream of Schlemm canal.¹
Clinical support for the OMNI platform’s earlier models comes primarily from prospective, multicenter studies rather than randomized controlled trials. The GEMINI study (NCT03861169), a single-arm trial of combined canaloplasty and trabeculotomy with cataract surgery in 120 eyes with mild to moderate open-angle glaucoma, reported a 34% reduction in mean diurnal unmedicated IOP and a 78% reduction in medication use at 12 months, with no serious device-related adverse events.³ The ROMEO study, a retrospective analysis of standalone and combined procedures in pseudophakic eyes, showed sustained IOP control through 2 years, with roughly three-quarters of patients meeting a composite success endpoint and no device-related adverse events reported during extended follow-up.⁴ Because OMNI Ultra received clearance based on substantial equivalence, these outcomes reflect prior-generation OMNI devices and cannot be assumed to transfer directly to the redesigned system.³,⁴
The 510(k) pathway does not require new clinical efficacy data when substantial equivalence to a predicate device is established, so the design changes in OMNI Ultra have not yet been evaluated in a published clinical study.¹ Whether automated viscodilation control meaningfully changes procedural consistency, complication rates, or the surgeon learning curve relative to earlier OMNI devices remains unknown pending postmarket data.¹,³,⁴ This report is based on a company announcement rather than peer-reviewed or FDA-published clearance documentation, and no device-specific outcomes data for OMNI Ultra were available at the time of writing.¹ Sight Sciences noted that commercial launch is anticipated in the fourth quarter of 2026, which may allow for real-world outcomes reporting.¹
