Sight Sciences Receives FDA Clearance For OMNI Ultra Surgical System To Treat Glaucoma

Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing innovative interventional treatments, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OMNI® Ultra Surgical System. The device is approved for use in canaloplasty followed by trabeculotomy to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG), the most common form of glaucoma.

OMNI Ultra is the latest addition to the company's implant-free minimally invasive glaucoma surgery (MIGS) portfolio. The system is designed to treat all three known areas of resistance in the eye's natural fluid drainage pathway—the trabecular meshwork, Schlemm's canal, and the collector channels—through a single clear corneal microincision without leaving an implant behind. It is also the first FDA-cleared MIGS device capable of performing circumferential canaloplasty in a single pass. The system features the new TruSync™ Plus technology, which provides controlled viscodilation during both advancement and retraction of the microcatheter, helping improve procedural precision and surgeon confidence.

The company said OMNI Ultra also offers greater flexibility by allowing surgeons to personalize treatment based on disease severity and surgical needs. The device can be used either as a standalone procedure or in combination with cataract surgery for adult patients with primary open-angle glaucoma. Enhanced catheter visualization further supports accurate treatment delivery during surgery.

Dr. Arkadiy Yadgarov, who contributed to the system's design enhancements and clinical evaluation, said OMNI Ultra builds on the strengths of the existing OMNI platform while introducing meaningful improvements in procedural efficiency and control. He noted that the ability to complete a full canaloplasty in a single pass, along with the automated and controlled viscodilation provided by TruSync Plus technology, gives surgeons greater confidence and flexibility when treating a broad range of glaucoma patients.

Sight Sciences Co-Founder and Chief Executive Officer Paul Badawi said the FDA clearance marks an important milestone in the company's efforts to advance implant-free glaucoma treatments. He added that OMNI Ultra builds on the proven OMNI platform by improving procedural control, treatment precision, and efficiency while maintaining the safety, reliability, and clinical effectiveness that surgeons have come to expect. The company believes the technology will help ophthalmologists intervene earlier and more comprehensively in glaucoma management.

The OMNI technology platform is supported by extensive clinical evidence, including prospective, real-world, and long-term studies demonstrating significant reductions in intraocular pressure and the need for glaucoma medications. More than 350,000 OMNI procedures have been performed worldwide, making it one of the leading implant-free MIGS technologies. Following FDA clearance, Sight Sciences is preparing for the U.S. commercial launch of OMNI Ultra, which is expected to take place in the fourth quarter of 2026.