Sight Sciences’ OMNI Ultra Surgical System Secures the US FDA 510(k) Clearance
Shots:
- The US FDA has granted 510(k) clearance to the OMNI Ultra Surgical System for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG)
- The OMNI platform is backed by extensive clinical evidence showing sustained IOP reduction and reduced medication use, with the OMNI Ultra remaining on track for its US commercial launch in Q4’26
- OMNI Ultra is an implant-free, FDA-cleared MIGS device that treats all three outflow resistance points through a single microincision, featuring single-pass circumferential canaloplasty, TruSync Plus tech for precise viscodilation, & enhanced treatment flexibility
Ref: Sight Sciences | Image: Sight Sciences | Press Release
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