Sight Sciences announced FDA 510(k) clearance of the OMNI Surgical System for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy to reduce IOP in adult patients with primary open-angle glaucoma. Although OMNI is already used for the delivery of small amounts of viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures, this clearance establishes OMNI as the first FDA-cleared, ab-interno device for standalone minimally invasive glaucoma procedures (MIGS) in adult patients with primary open-angle glaucoma.

Historically, the vast majority of MIGS procedures have been performed solely in combination with cataract surgery, given the limitations on the indications for use of MIGS implants. Sight Sciences estimates that approximately 10% of US primary open-angle glaucoma patients require combination cataract surgery. This has left mild-to-moderate primary open-angle glaucoma patients who do not have a cataract without a device or procedure indicated for lowering IOP from an ab-interno approach. The expanded label positions OMNI as the first comprehensive MIGS device cleared for use across the spectrum of primary open-angle glaucoma patients.