The US Food and Drug Administration (FDA) has granted 510(k) clearance of the Omni Ultra Surgical System (Omni Ultra; Sight Sciences) for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG).

Like previous versions of the Omni Surgical System, Omni Ultra is designed to reduce IOP by addressing all 3 known areas of resistance within the conventional aqueous outflow pathway: the trabecular meshwork, the Schlemm's canal, and the collector channels. It is the first FDA-cleared minimally invasive glaucoma surgery (MIGS) device for circumferential canaloplasty in a single pass, Sight Sciences said in a press release. The technology can be used as a standalone procedure or in combination with cataract surgery in adult patients with POAG. 

According to the company, Omni Ultra features TruSync Plus technology for canaloplasty and includes enhanced catheter visualization and expanded treatment options. Sight Sciences said the US commercial launch of Omni Ultra is on track for the fourth quarter of 2026. GP