Sight Sciences (Nasdaq: SGHT) said on August 4, 2026 that the U.S. Food and Drug Administration has granted 510(k) clearance for its OMNI Ultra Surgical System, a next-generation handheld device that performs canaloplasty followed by trabeculotomy for adult primary open-angle glaucoma patients. The Menlo Park company plans a US commercial launch in the fourth quarter of 2026.
A first in MIGS
OMNI Ultra is the first FDA-cleared minimally invasive glaucoma surgery device that can perform circumferential canaloplasty in a single pass, addressing all three known areas of outflow resistance - the trabecular meshwork, Schlemm's canal and the collector channels - through one clear corneal microincision. The device is implant-free and single-use, and includes the company's new TruSync Plus technology for controlled viscodilation during microcatheter advancement and retraction.
Anchoring the OMNI franchise
OMNI Ultra joins a platform that Sight Sciences says has been used in more than 350,000 procedures worldwide. CEO Paul Badawi called the clearance a 'meaningful innovation' that extends the company's leadership in canal-based MIGS, positioning it against implant-based competitors and Nasdaq peers Alcon and Glaukos. Sight Sciences also announced the same week that Aetna added coverage for OMNI and its bladeless SION system, expanding reimbursement ahead of the Q4 rollout.
Momentum in ophthalmic devices
The clearance lands as robotic and interventional eye-care companies race for regulatory wins. TRM's coverage of ForSight Robotics' JASPER 26-case cataract milestone and Cognita's FDA breakthrough tag shows a broader push to automate high-volume specialty procedures. Glaucoma remains the world's leading cause of irreversible blindness, and MIGS has been the industry's fastest-growing segment for three years.
Reporting based on coverage from GlobeNewswire, BioSpace and MPO Magazine.