iStent infinite®: Clinical Data Review

At present, iStent infinite^® (Glaukos Corporation) is just entering the market. The concept behind this device is to address more advanced glaucoma—particularly moderate-to-advanced stages—in contrast to the earlier iStent inject^® (Glaukos Corporation), which primarily targeted patients with mild disease.

In the pivotal Samuelson 2019 iStent inject^® study,¹² the mean visual field MD was -3.4 dB, whereas in the new pivotal Sarkisian iStent infinite^® study,¹³ the mean visual field MD was -14.4 dB—a striking difference, suggesting that the new device is intended for more severe glaucoma cases.

Study 1: Pivotal Sarkisian iStent infinite^® Trial

This study enrolled patients with uncontrolled open-angle glaucoma and a medicated IOP of 20–35 mm Hg.¹³ There was no medication washout, and two main patient groups were studied:

1. Failed surgery group: uncontrolled by medical therapy and one or more conventional incisional or cilioablative procedures (eg. trabeculectomy, tube implantation, cryotherapy and cyclodiode therapy).

2. Maximally tolerated medical therapy group: Patients on four or more medications, yet still uncontrolled.

Exclusion criteria included prior argon laser trabeculoplasty (ALT), recent glaucoma or intraocular surgery (within 90 days), elevated episcleral venous pressure, and secondary glaucoma.

Safety parameters included inflammation, IOP increase, need for further glaucoma surgery, visual field loss or disease progression, and stent-related events such as obstruction. The study also measured BCVA, visual fields, fundus, and slit-lamp biomicroscopy.

The primary endpoint was achieving a ≥20% reduction in IOP or lower IOP on fewer medications without adverse events. The secondary endpoint was a mean diurnal IOP reduction from baseline.

There was a marked difference between the two subgroups—more patients were in the failed surgery cohort, and many had advanced glaucoma.

At 12 months, 76% of all patients achieved a clinically meaningful ≥20% IOP reduction. Even more notably, 73.4% of the failed-surgery group met this goal—an impressive outcome considering their prior surgical history. The mean IOP reduction was >8 mm Hg in the medication group and >5 mm Hg in the failed-surgery group. Furthermore, 31% of the failed-surgery eyes achieved IOP ≤15 mm Hg, a meaningful improvement compared with prior interventions.

Safety Results

The iStent infinite^® demonstrated exceptional intra- and postoperative safety. In the trial, there were no cases of hypotony, no explants, no cyclodialysis clefts, and no device-related interventions. Only three eyes required secondary surgical intervention. This highlights the safety and tolerability of the device even in complex, high-risk patients.

Study 2: iStent infinite^® vs. Hydrus (Ahmed et al.)

A second study by Iqbal Ike K. Ahmed, MD, FRCSC, and colleagues compared iStent infinite^® directly to the Hydrus over 6 months in uncontrolled open-angle glaucoma.¹⁴ In this prospective, multicenter, single-arm, open-label clinical trial, iStent infinite^® was again performed as a standalone procedure, but here patients were washed out of medication, entering the study with unmedicated mean diurnal IOP between 21 and 36 mm Hg. Exclusion criteria mirrored the prior study, again ruling out prior ALT, recent surgery, secondary glaucoma, and chronic inflammation.

The two study groups were comparable at baseline, including a mix of mild, moderate, and severe glaucoma cases.

At month 6, the proportion of eyes achieving ≥20% unmedicated IOP reduction without surgical complications was significantly higher with iStent infinite^®, showing a 13.2% advantage over Hydrus (Figure 3).

When evaluating mean change in unmedicated IOP, the iStent infinite^® again performed better, with a statistically significant improvement over the Hydrus group (Figure 4).

At month 6, looking at IOP categories of <21, <18, and <15 mm Hg, both devices showed improvement, but iStent infinite^® consistently outperformed Hydrus. Notably, 35% of iStent infinite^® patients achieved ≤15 mm Hg, compared to fewer in the Hydrus group. In terms of percent IOP reduction, both achieved ≥40% lowering in roughly 20% of patients, but again, iStent infinite^® demonstrated superior results.

Adverse Events and Conclusions

Both devices had mild adverse events, but Hydrus exhibited more complications, mainly due to difficulty in correct anatomical placement and a higher incidence of peripheral anterior synechiae despite all investigators being highly experienced in Hydrus implantation prior to the study.

In conclusion, these studies demonstrate that iStent infinite^® provides unmedicated IOP lowering, fewer adverse events, and fewer surgical complications than the Hydrus. The differences likely reflect the smaller size, simpler implantation, and shorter learning curve of the iStent infinite^®.

While long-term results are still awaited, current data suggest that the iStent infinite^® is a safe, effective, and promising new device for patients with moderate-to-advanced glaucoma.

Stent inject^® IMPORTANT SAFETY INFORMATION

INDICATIONS FOR USE: The iStent inject^® is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject^® can deliver two (2) stents on a single pass, through a single incision. The implant is designed to stent open a passage through the trabecular meshwork to allow for an increase in the facility of outflow and a subsequent reduction in intraocular pressure. The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery. CONTRAINDICATIONS: The iStent inject^® System is contraindicated under the following circumstances or conditions: • In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations • In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS/PRECAUTIONS: • For prescription use only. • This device has not been studied in patients with uveitic glaucoma. • Do not use the devices if the Tyvek^® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised. • Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container. • iStent inject^® is MR-Conditional • Physician training is required prior to use of the iStent inject^® System. • Do not re-use the stent(s) or inserter, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events • There are no known compatibility issues with the iStent inject^® and other intraoperative devices (e.g., viscoelastics) or glaucoma medications. • Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products must be disposed of as medical waste. • Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body • The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure.

iStent infinite^® IMPORTANT SAFETY INFORMATION

INDICATIONS FOR USE: The iStent infinite System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and/or conventional glaucoma surgery. CONTRAINDICATIONS: The iStent infinite System is contraindicated under the following circumstances or conditions: •In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations.• In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure WARNINGS/PRECAUTIONS: • For prescription use only. • Intended users are trained ophthalmologists only. • This device has not been studied in patients with uveitic glaucoma. • Do not use the device if the Tyvek^® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised. • Due to the sharpness of certain injector components (i.e., the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container. • iStent infinite is MR-Conditional • Physician training is required prior to use of the iStent infinite System. • Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events • There are no known compatibility issues with the iStent infinite and other intraoperative devices (e.g., viscoelastics) or glaucoma medications. • Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products must be disposed of as medical waste. • The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure. • Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients can enhance the formation or progression of cataract. ADVERSE EVENTS: The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baselineIOP (8.2%), loss o f BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.

For additional safety information on iStent products, see here: www.glaukos.com

Glaukos^®, iStent^®, iStent inject^® W and iStent infinite^® are registered trademarks of Glaukos Corporation. All rights reserved. ©2026. Third-party trademarks are the property of their respective owners. PM-EU-0391