Sight Sciences, Inc. has received FDA 510(K) clearance for the OMNI Ultra Surgical System, designed for minimally invasive glaucoma surgery (MIGS).
First up: a refresh on OMNI.
First debuting in 2018, the OMNI product line kicked off with the FDA’s clearance of Sight Science’s original OMNI Surgical System.
About that system: Its initial clearance was dually indicated for the delivery of controlled volumes of viscoelastic fluid during ophthalmic surgery and cutting of trabecular meshwork (TM) tissue during trabeculotomy procedures.
- See here for how it works.
Fast forward to 2021: The system became the first (and only) implant-free, single-use ab interno glaucoma device indicated for canaloplasty followed by trabeculotomy to reduce intraocular pressure (IOP).
- Its target patients: Adults with primary open-angle glaucoma (POAG).
And more recently?
Two more updates have been added to the OMNI line:
In March 2023: The Ergo-Series was introduced, building on the original system with three new features to enable improved ergonomic function and precise access.
And more recently (April 2025): The OMNI Edge was unveiled for use as a versatile and implant-free MIGS procedure—either standalone or in combination with cataract surgery—that is adaptable for all POAG stages.
- See here for details on its unique technology.
Now to this OMNI Ultra addition.
As with prior installments in the OMNI series, the OMNI ultra is designed as a hand-held and single-use therapeutic device intended to reduce intraocular pressure (IOP) by addressing all three known areas of resistance within the conventional aqueous outflow pathway:
- Trabecular meshwork
- Schlemm's canal
- Collector channels
The technology can be used as a standalone procedure or in combination with cataract surgery in adult patients with POAG.
Most notably: Its claim to fame is being the first FDA-cleared MIGS device for circumferential canaloplasty in a single pass.
And the technology accompanying this?
That would be the patented, higher-capacity viscoelastic delivery TruSync Plus technology (which, take note, is also included in the OMNI Edge).
What to know: This technology gives surgeons enhanced control, precision, and more confidence in delivering “automatic and controlled viscodilation upon microcatheter advancement and retraction.”
- More specifically: It delivers up to 11 µL of viscoelastic and provides 360° access to the eye’s conventional outflow system through a single clear corneal microincision.
What other features are included?
The system offers a comprehensive, implant-free intervention that addresses all three (known) areas of outflow resistance via a “single, clear corneal microincision.”
Along with this comes an expanded treatment versatility, in which surgeons have the flexibility to deliver “personalized treatment across varying disease severities and surgical settings.”
- Simultaneously, the OMNI Ultra offers “enhanced catheter visualization to help surgeons confidently assess and tailor treatment delivery.”
And what about potential contraindications and other precautions to keep in mind?
While those details were readily available for the OMNI Edge, we were unable to identify any relating specifically to the OMNI Ultra.
Reach out to the company directly for more information.
Duly noted. Now, let’s talk supporting clinical data for this system.
As we’ve previously reported, the OMNI technology platform has undergone extensive real-world and long-term studies to support its use for IOP reduction among POAG patients.
See here and here for a look at a few of these.
Next up: availability.
Sight Sciences is currently on track to launch the OMNI Ultra in Q4 2026 (so sometime between Oct. 1 and the end of the year).
And one more note: Sight Sciences also announced last week that Aetna, Inc has updated its glaucoma surgery policy to recognize the OMNI Surgical System as “medically necessary” for the treatment of mild-to-moderate POAG “when specified clinical criteria are met.”