Completing the Eye’s Drainage Circuit in One Pass: OMNI Ultra Glaucoma Surgical System Receives FDA Clearance

The challenge of glaucoma surgery is not only to lower intraocular pressure, but also to relieve multiple levels of resistance within the eye’s drainage system through a smaller incision. OMNI Ultra Surgical System, developed by U.S. medical device company Sight Sciences, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). It is indicated for adults with primary open-angle glaucoma and enables canaloplasty followed by trabeculotomy during the same procedure.

This is a handheld, single-use, implant-free device for minimally invasive glaucoma surgery (MIGS). Through a small incision in the clear cornea, the physician enters the anterior chamber and sequentially treats the trabecular meshwork, Schlemm’s canal, and collector channels along the aqueous outflow pathway. The trabecular meshwork often represents the primary source of resistance, while Schlemm’s canal and the collector channels carry aqueous humor toward the circulation outside the eye.

Compared with the previous-generation design, OMNI Ultra adds the ability to complete circumferential canaloplasty with a single advancement. Its TruSync Plus technology controls the injection of viscoelastic material as the microcatheter advances and withdraws, dilating Schlemm’s canal before the trabecular meshwork is opened. The company says this is the first FDA-cleared MIGS device capable of completing circumferential canaloplasty with a single advancement; this “first” designation currently comes primarily from the company’s own claim.

The system can be used as a standalone glaucoma procedure or combined with cataract surgery. This allows physicians to select different intervention timing depending on whether a patient also requires lens replacement. However, whether the device can reduce intraoperative steps, shorten the learning curve, or enable more patients to reduce medication use remains to be determined by real-world clinical data.

The FDA’s 510(k) pathway primarily determines whether a new device is “substantially equivalent” to a legally marketed predicate device; it is not the same as demonstrating superior efficacy through a large comparative trial. This announcement did not provide the number of OMNI Ultra trial participants, the magnitude of intraocular pressure reduction, changes in medication use, or complication rates, nor did it disclose direct comparisons with existing MIGS technologies. At this stage, therefore, its eligibility for marketing and procedural capabilities are clearer than any claim of clinical superiority.

Sight Sciences expects to launch OMNI Ultra in the United States in the fourth quarter of 2026. The pace of adoption after launch will depend on physician training, surgical workflows, reimbursement conditions, and real-world performance in intraocular pressure control and safety. For patients, the most appropriate surgical option will still need to be assessed individually according to glaucoma severity, response to existing treatments, and ocular anatomy.