Research recently published in the American Journal of Ophthalmology reveals real-world, 36-month data that confirms the long-term effectiveness of Sight Sciences’ OMNI Surgical System in managing primary open-angle glaucoma (POAG).
Let’s start with OMNI.
This FDA-cleared (in 2021) system is the first—and currently only—implant-free, single-use therapeutic glaucoma device indicated for canaloplasty followed by trabeculotomy.
What it does: Reduce intraocular pressure (IOP) in adults with POAG.
Specifically: The restorative minimally-invasive glaucoma surgery (MIGS) procedure is designed to reestablish the eye’s natural outflow drainage system.
- How it does this: By opening and potentially restoring flow through three points of known resistance (see below) within the conventional outflow pathway of the eye via a single, clear corneal microincision:
- Trabecular meshwork
- Schlemm’s canal
- Collector channels
Has it had any clinical updates since its approval?
Product-wise, Sight Sciences launched a new addition to the OMNI in March 2023: the Ergo-Series.
What that is: A new design for the MIGS technology that builds on the original system by featuring three new components (click here for those—plus a visual) focusing more on an improved “ergonomic” (get it?) function.
Nice! How about clinical research?
Oh yes … the OMNI has been involved in a number of clinical trials following its 2021 clearance.
We’ve covered a few (and keep in mind, this is not a comprehensive list):
- May 2023: 2-year data released from an extension of the 12-month ROMEO study
- October 2023: New 2-year MIGS data support TCOR using OMNI Surgical System
- April 2024:
The general findings: Use of the OMNI for treating POAG resulted in a sustained and significant IOP reduction when used both alone and in combination with cataract surgery.
Interesting … now talk about this new research.
The retrospective, observational cohort, real-world study of OMNI was conducted using data from the American Academy of Ophthalmology (AAO) Intelligent Research in Sight (IRS) Registry and a pharmacy claims dataset.
- Note: This dataset was a deidentified claims-based database of both medical and pharmacy claims that was linked to the IRIS Registry and used to describe patient-level glaucoma medication usage.
And the participants in the study?
A total of 196 patients (230 eyes) were enrolled with a mean age of 75.
- 53% female
- 53.6% White
Check out the complete inclusion criteria here.
Give me a rundown of the data that was collected.
- Demographics (age, sex, race, ethnicity, payor type, laterality of study eye)
- 82.7% and 17.4% received their procedure unilaterally and bilaterally, respectively
- Clinical characteristics (phakic or pseudophakic; glaucoma severity; dry eye presence)
- 66% were pseudophakic; 47.4% had comorbid dry eye
- Glaucoma type: 14.4% (mild), 40% (moderate), and 41.3% (severe)
- Ophthalmic specialty
- 44.4% of procedures were performed by glaucoma specialists; 25.7% by cataract/anterior segment specialists; and 13.5% by comprehensive ophthalmologists (16.5% by other providers)
- IOP and medication use (at baseline, 6, 12, 18, 24, and 36 months) postoperatively
- Timing and type of secondary surgical interventions for glaucoma
- Preoperatively: 1.2% underwent other MIGS procedure 1 year prior; 13.9% underwent trabeculoplasty >90 days
Now to the findings.
We’ll start with IOP changes among these participants:
- Mean (SD) baseline IOP: 22.1 (6.4) mmHg
Over the 36-month postoperative period, participants’ mean IOP ranged from 15.1 to 16.7 mmHg (p < 0.0001 at each time point versus baseline).
- Click here for the breakdown between months (6, 12, 18, 24, and 36).
Go on …
The mean IOP reduction ranged from 5.6 to 7.1 mmHg, “demonstrating clinically and statistically significant reductions in [IOP],” Sight Sciences reported.
Notably: Higher IOP reductions (up to 8.9 mmHg) were noted among high baseline IOP patients ( >18 mmHg).
And meanwhile:
- Eyes with low baseline IOP (< 18 mmHg) experienced reduced medication use through 36 months
- Eyes with higher baseline IOP had “statistically significant reductions in IOP and reductions in mediation use through 36 months”
Stick with medication use for a moment.
Investigators observed “clinically and statistically significant medication reductions through 18 months in the full sample [p < 0.0011] and through 36 months in patients with lower baseline IOP (in whom medication reduction was likely a surgical goal).”
- Further: Half or more of patients were medication-free at 36 months.
The mean number of glaucoma meds used at baseline: 2.1 (1.5), with a range of 1.1 to 1.6 medication classes between months 6 and 36
Interesting … so how did this data compare to previous studies?
Referring to the trial as “the largest study to date” to explore clinical outcomes of standalone canaloplasty and trabeculotomy using the OMNI system, the study authors stated that the results compared “favorably” to prior research.
- See here for details on the ROMEO study and its extension and here for data on OMNI from 1 to 2-year retrospective studies.
The authors added: With 36-month data included in this current study, it “demonstrated continued effectiveness of standalone OMNI surgery with either IOP or medication reductions over time, for the majority of patients, particularly those with lower baseline IOP, supporting the long-term benefit of this procedure in glaucoma management.”
- The findings were also favorably compared to other standalone procedures (see here).
And for the future?
The authors concluded that, while standalone OMNI surgery represents a reasonable MIGS option for POAG patients, future research should focus on outcomes for specific subgroups—focusing on disease severity and lens status (phakic of pseudophakic).