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Sight Sciences has received FDA 510(k) clearance for its OMNI® Ultra Surgical System, expanding its implant-free minimally invasive glaucoma surgery (MIGS) portfolio for treating adults with primary open-angle glaucoma.
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The next-generation system is the first FDA-cleared MIGS device for single-pass circumferential canaloplasty and features TruSync™ Plus technology, designed to improve procedural control, precision, and surgeon confidence during treatment. OMNI Ultra addresses multiple areas of resistance in the eye’s conventional drainage pathway through a single microincision, with or without cataract surgery.
The clearance marks a key milestone ahead of the planned U.S. commercial launch in Q4 2026, building on the OMNI platform’s adoption across more than 350,000 procedures worldwide.
“OMNI Ultra represents the latest evolution of the proven OMNI platform,” said Paul Badawi, Co-Founder and CEO of Sight Sciences. “We’re building on the platform with enhanced control, procedural efficiency, and treatment precision, while maintaining the simplicity, reliability and efficacy surgeons trust.”
