Data-Driven Clinical Care

Minimally invasive glaucoma surgery (MIGS) continues to shape the management of open-angle glaucoma (OAG), as newer devices expand the range of available interventions. As a glaucoma surgeon practicing in both public and private settings in London, I routinely perform angle-based MIGS procedures, most often using the OMNI® Surgical System (Sight Sciences). My colleagues and I rely on emerging clinical evidence to guide our surgical decision-making and optimize outcomes. Recently, I was privileged to coauthor a systematic review and meta-analysis evaluating the clinical, humanistic, and economic evidence supporting the OMNI device and its predecessors (Trab360 & Visco360), published in the European Journal of Ophthalmology (2025).¹ This article summarizes the findings and contextualizes them within current clinical practice.

DEVICE BACKGROUND AND RATIONALE

The OMNI Surgical System is designed to address multiple points of aqueous outflow resistance by combining viscodilation of Schlemm’s canal with trabeculotomy, providing a dual-mechanism approach to IOP reduction in adults with OAG. As clinical use of this device grows, it is essential that its application be informed by data of sufficient quality regarding its efficacy, safety, and cost-effectiveness.

To evaluate the strength of clinical evidence supporting the use of OMNI and its predicate devices, my coauthors and I performed a systematic review and meta-analysis of outcomes associated with OMNI in patients with OAG.¹ The analysis encompassed 2,379 eyes across 22 unique studies (four studies on OMNI in standalone use, 11 in combination with cataract surgery, and seven both standalone and combined). With this large dataset, we aimed to provide evidence-based guidance on treatment planning across a diverse cohort of patients. The review included data for OMNI and its earlier iterations that used the same ab-interno approach to perform either canaloplasty (Visco360) or trabeculotomy (Trab360).

It must be noted, however, that most of the included studies were retrospective or observational in design, with potential sources of bias, heterogeneity, and small-study effects. Most contributing studies lacked control arms, limiting causal inference. Our results, though encouraging, must be interpreted within the context of study design limitations and variability in follow-up duration, baseline disease severity, and surgical technique. Despite these limitations, the pooled evidence provides a useful overview of real-world performance trends for OMNI.

FINDINGS FROM THE SYSTEMATIC REVIEW

IOP Reduction

Across the included publications, the OMNI system demonstrated consistent reductions in IOP over time. Baseline IOPs ranged from 14.1 to 28.8 mmHg, with mean reductions of 6 to 10 mmHg in eyes with baseline IOP ≥18 mmHg at 12 months, and smaller but sustained decreases (approximately 1–2 mmHg) in eyes with lower baseline pressures. These reductions were observed as early as 6 months and generally maintained through 24 and, in some reports, up to 36 months. Importantly, these outcomes were observed both in standalone procedures and when OMNI was combined with cataract surgery.

Clinical Perspective: A sustained reduction of IOP below 18 mmHg through 24 months is significant to the glaucoma surgeon, whose primary objective is to prevent glaucomatous optic neuropathy progression and worsening of the visual field. A cardinal trial in glaucoma, the Advanced Glaucoma Intervention Study, demonstrated the critical importance of IOP reduction in preventing glaucomatous visual field progression.²

Medication Reduction

My co-investigators and I also observed a meaningful decrease in medication burden among patients treated with OMNI, despite variability between study designs. Patients began treatment on an average of 0.9 to 3.4 medications, which fell to 0.1 to 2.2 medications at 12 months and 0.5 to 1.6 medications at 24 months (standalone and combination procedures). Approximately 66% to 68% of patients remained medication-free at 6 and 12 months. This trend persisted at 24 months, suggesting durable medication reduction in many cases. Nevertheless, medication outcomes should be interpreted cautiously due to potential reporting bias and differences in washout protocols.

Clinical Perspective: These outcomes reflect my observations within my own practice. The patients I treat with OMNI regularly stop using one to two medications within the first postoperative month, particularly those who exhibit glaucoma-therapy–related ocular surface disease. The quality-of-life impact on patients from medication reduction should also be considered.^3,4 The literature reports that up to 50% of glaucoma patients fail to adhere to their topical glaucoma treatments, resulting in extensive fluctuations in IOP and a resultant progression of their disease.⁵

Efficacy & Safety

Treatment success across the included studies—defined as a ≥20% reduction in IOP from baseline—was achieved in approximately 99% of patients at 6 months, 83% at 12 months, and 93% at 24 months, with sustained IOP control reported up to 36 months. These findings are based on pooled data from over 2,300 eyes across 22 studies. Secondary surgical intervention (SSI) rates were low overall (0.6% to 25%) but varied depending on patient selection and prior surgical history. Higher SSI rates were noted in studies involving refractory eyes or those with prior surgical or laser treatments, which underscores the importance of patient selection.

Reassuringly, reported adverse events across the studies were generally mild and transient, and none were serious. The two most common adverse events were hyphema and IOP spikes, which typically resolved within 3 months.

Clinical Perspective: My personal rate of hyphema in OMNI procedures is approximately 10% and typically less than 1 mm, possibly due to limiting the trabeculotomy to 2–3 clock hours. Nor are my rates of anterior uveitis and cystoid macular edema significantly higher than in conventional standalone cataract surgery, particularly with intraoperative intracameral corticosteroid injections. This safety profile is consistent with outcomes reported for other MIGS approaches, including stents and laser-based procedures. Two benefits of OMNI are the direct visual feedback for successful Schlemm’s cannulation and not having limitations on device implantation or treatment delivery.

CLINICAL INTERPRETATION AND REAL-WORLD DECISION MAKING

Our systematic review confirms that OMNI achieves clinically meaningful IOP reduction and medication burden relief across diverse patient populations with OAG, whether used alone or in combination with cataract surgery. Across the studies analyzed, approximately two-thirds of patients remained medication-free at 12 months, and a substantial proportion of patients achieved at least a ≥20% reduction in IOP. At 12 months, average IOP values typically ranged from 11.5 to 17.2 mmHg—levels generally associated with slower glaucoma progression.

While the individual study results varied depending on baseline characteristics, these consistent results across diverse real-world and prospective studies reinforce OMNI as a reliable, implant-free, ab-interno approach for managing OAG.

Importantly, OMNI demonstrated significant and lasting IOP and medication reductions even in standalone procedures, suggesting a reduction greater than typically seen after cataract surgery alone. This makes it a valuable option for pseudophakic patients, those unsuitable for filtration surgery, or eyes with prior trabeculectomy or angle surgeries. The review supports consideration of OMNI as part of the surgical options for suitable patients on medical therapy. With durable results observed over 24 to 36 months and a favorable safety profile, OMNI offers a practical solution for long-term IOP control and medication burden reduction in OAG management.

Important Product Information

This information is intended solely for healthcare professionals located in the UK and EU. Patients should direct questions to their healthcare professional.

INDICATIONS FOR USE: The OMNI Surgical System is indicated for the catheterization and transluminal viscodilation of Schlemm’s canal and the cutting of trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.

For important product information including cautions and adverse events, please refer to the full instructions for use available at omnisurgical.com/international

OMNI and the Sight Sciences logo are registered trademarks of Sight Sciences, Inc.

©2026 Sight Sciences, Inc. 02/26

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