Sight Sciences Receives FDA 510(k) Clearance of the OMNI Ultra Surgical System

Sight Sciences, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OMNI ® Ultra Surgical System, which is designed for canaloplasty followed by trabeculotomy aimed at reducing intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG).

The OMNI Ultra offers a comprehensive implant-free intervention that addresses all three areas of outflow resistance through a single, clear corneal microincision. It is the first FDA-cleared device for circumferential canaloplasty performed in a single pass. The system features TruSync™ Plus technology, which enhances control and precision throughout the canaloplasty procedure.

Dr. Arkadiy Yadgarov, involved in the design and evaluation of the system, noted that OMNI Ultra encapsulates the commitment of Sight Sciences to collaborate with surgeons and advance the treatment options available for glaucoma patients. He emphasized the system’s ability to perform thorough and customizable procedures efficiently, which is crucial for a range of glaucoma patients undergoing different surgical settings.

Paul Badawi, Co-Founder and CEO of Sight Sciences, stated that the FDA clearance signifies an important milestone for the company as they continue to invest in innovative glaucoma technologies. He highlighted the significance of addressing the conventional outflow pathway in glaucoma treatment and asserted that OMNI Ultra enhances the procedural efficiency and treatment precision of its predecessor, the OMNI platform.

The OMNI Ultra Surgical System is a handheld, single-use device designed for minimally invasive glaucoma surgery. It aims to improve patient treatment paradigms by targeting the underlying causes of prevalent eye diseases. Following the recent FDA clearance, the company is preparing for the U.S. commercial launch of OMNI Ultra, targeted for the fourth quarter of 2026.