USFDAAug 4, 2026, 05:39 PM
Sight Sciences OMNI Ultra Surgical System Gets FDA Clearance
AI Summary
Sight Sciences, Inc. announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OMNI® Ultra Surgical System. This next-generation device is indicated for canaloplasty followed by trabeculotomy to reduce intraocular pressure in adult patients with primary open-angle glaucoma. Key features include comprehensive implant-free intervention, single-pass circumferential canaloplasty, and TruSync™ Plus technology for enhanced control. The company plans for a U.S. commercial launch in the fourth quarter of 2026.
Key Highlights
- Sight Sciences received FDA 510(k) clearance for its OMNI Ultra Surgical System.
- OMNI Ultra is indicated for canaloplasty followed by trabeculotomy to reduce IOP in adult POAG patients.
- The system offers comprehensive implant-free intervention through a single microincision.
- It is the first FDA-cleared MIGS device for circumferential canaloplasty in a single pass.
- Features TruSync™ Plus technology for enhanced control and precision during viscodilation.
- U.S. commercial launch of OMNI Ultra is on track for the fourth quarter of 2026.
- The OMNI technology platform has been used in over 350,000 procedures worldwide.
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