FDA Clears Sight Sciences’ OMNI Ultra for Glaucoma

FDA has cleared Sight Sciences’ OMNI Ultra Surgical System, a 510(k) premarket notification the company announced 4 August 2026 for canaloplasty followed by trabeculotomy to reduce intraocular pressure in adults with primary open-angle glaucoma. The clearance extends a device platform already used in more than 350,000 procedures, and it lands as minimally invasive glaucoma surgery — MIGS — continues to reshape where in the treatment sequence surgeons are willing to intervene.

What the clearance covers

The indication is specific: canaloplasty — microcatheterization and viscodilation of Schlemm’s canal — followed by trabeculotomy, the cutting of trabecular meshwork tissue, to lower intraocular pressure in adults with primary open-angle glaucoma. That is the same procedural combination the original OMNI Surgical System has offered; the 510(k) for OMNI Ultra is a new device cleared as substantially equivalent to that predicate, not a new drug approval or a PMA. FDA’s Center for Devices and Radiological Health reviews 510(k)s against a predicate’s intended use and technological characteristics rather than requiring independent clinical trials, which is why a clearance can move faster than a full premarket approval — and why the underlying question for a submission like this one is equivalence, not novelty.

What the company says is new

Sight Sciences frames OMNI Ultra as addressing outflow resistance across all three structures glaucoma surgeons target — trabecular meshwork, Schlemm’s canal, and the collector channels — through one clear corneal microincision, without leaving any implant in the eye. The device adds what the company calls TruSync Plus technology, intended to give surgeons more predictable control over viscodilation as the catheter advances and retracts through the canal. Sight Sciences CEO Paul Badawi described the clearance as reflecting “continued investment and meaningful innovation” in implant-free glaucoma interventions, and said the device is meant to let surgeons work across a broad range of disease severities and surgical settings, whether combined with cataract surgery or performed standalone.

Why a 510(k), not a PMA

• Predicate-based review: the original OMNI Surgical System is FDA-cleared for the same canaloplasty-plus-trabeculotomy indication; OMNI Ultra’s 510(k) rests on substantial equivalence to that device.
• No implant, no PMA trigger: because the procedure leaves nothing behind in the eye, it falls outside the implanted-device category that typically requires the more demanding premarket approval pathway.
• Scale already in the field: the company cites more than 350,000 OMNI-family procedures performed worldwide, a track record that plausibly supported the substantial-equivalence case for the newer catheter design.
• Launch timing: Sight Sciences says commercial availability in the US is on track for the fourth quarter of 2026, a relatively short gap between clearance and market entry that is typical for a 510(k) rather than a PMA.