300+ Publications
Procedural Pharmaceuticals
iDose TR is a procedural pharmaceutical that delivers prostaglandin analog therapy for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Trabecular Micro-bypass Technologies
20 Years of Data. 20K+ Eyes Studied. 20+ Countries.
iStent® technologies have achieved the unprecedented clinical data milestone of 300+ peer-reviewed publications highlighting the efficacy and safety of these MIGS devices around the world. This achievement represents the largest, most diverse, and longest-term body of clinical data for any MIGS procedure.
| Title | Author(s) | Study Details | Distinguishing Feature | Key Findings |
|---|---|---|---|---|
| Efficacy and safety of the travoprost intraocular implant in reducing topical IOP‑lowering medication burden in patients with open‑angle glaucoma or ocular hypertension1 | 3 years |
Randomized, double-masked, multicenter, phase 2 trial data evaluating the long-term safety and efficacy of travoprost intraocular implant |
Mean post-Op IOP (mmHg): 7.3-8.0 reduction for SE implant The safety of the travoprost intraocular implant was favorable over the 3-year study. View |
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| Pivotal trial: Travoprost intracameral implant for open-angle glaucoma or ocular hypertension: 12-month results of a randomized, double-masked trial2 |
1 year |
Multicenter, randomized, double-masked, pivotal phase 3 trial evaluating the efficacy and safety of the travoprost intraocular implant |
Mean post-Op IOP (mmHg): 81% of iDose TR patients were completely free of IOP-lowering topical medications at 1 year. View |
|
| Phase 3 randomized clinical trial of the safety and efficacy of travoprost intraocular implant in patients with open-angle glaucoma or ocular hypertension3 | 3 year |
Multicenter, randomized, double-masked, sham-controlled, noninferiority trial |
Mean post-Op IOP (mmHg): 6.6-8.5 reduction for SE implant iDose TR was proven statistically and clinically noninferior to twice-daily timolol maleate ophthalmic solution 0.5%. View |
|
| Travoprost intracameral implant demonstrates superior IOP lowering versus topical prostaglandin analog monotherapy in patients with open‑angle glaucoma or ocular hypertension4 | 3 months |
Subgroup analysis of data from the 2 multicenter, randomized, double- masked, active- controlled phase 3 pivotal trials |
Mean post-Op IOP (mmHg): 16.7
Compared to pre-study topical PGA monotherapy, the IOP-lowering effect of SE-iDose TR was:
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| Title | Author(s) | Study Details | Distinguishing Feature | Key Findings |
|---|---|---|---|---|
| Pivotal trial: Effectiveness and safety of iStent infinite trabecular micro-bypass for uncontrolled glaucoma5 |
12 months |
Pivotal trial data demonstrating safety and efficacy in patients uncontrolled by prior surgical or medical therapy |
Mean post-op IOP: 5.9(0.6) mmHg 91.7% of subjects in the failed prior surgery subgroup reduced or maintained medication burden at 12 months. View |
| Title | Author(s) | Study Details | Distinguishing Feature | Key Findings |
|---|---|---|---|---|
| Rates of visual field change and functional progression in glaucoma following trabecular microbypass implantation of iStent technologies: a meta-analysis6 | 12-96 months |
Long-term visual field loss data for combined and standalone procedures |
Weighted mean post-op IOP: 13.95 mmHg Visual field loss was similar to non-glaucomatous eyes and slower than medically treated glaucoma. View |
|
| Sustained 7-year glaucoma control after second-generation trabecular micro-bypass with or without cataract surgery7 | 7 years |
Long-term data for combined and standalone procedures |
Mean post-op IOP: 14.1 mmHg |
|
| Three-year outcomes of second-generation trabecular micro-bypass stents (iStent inject) with phacoemulsification in various glaucoma subtypes and severities8 | 3 years |
Real-world data on diverse glaucoma subtypes and severities |
Mean post-op IOP: 13.17 mmHg |
|
| Pivotal trial: Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract9 |
2 years |
Pivotal trial for iStent inject® |
Mean post-op IOP: 17.1 mmHg |
|
| Treatment success across different levels of preoperative disease burden: stratified two-year outcomes from the pivotal trial of iStent inject® trabecular micro-bypass in primary open-angle glaucoma and cataract10 | 2 years |
Demonstrates efficacy in patients with high baseline IOP |
Mean post-op IOP reduction by baseline IOP |
|
| Multicenter effectiveness and disease stability through 3 years after iStent trabecular micro-bypass with phacoemulsification in glaucoma and ocular hypertension11 | 3 years |
Large multicenter trial covering a diverse population |
Mean post-op IOP: 13.9 mmHg |
|
| Pivotal trial: Quality of life in primary open-angle glaucoma and cataract: an analysis of VFQ-25 and OSDI from the iStent inject® pivotal trial12 |
2 years |
Only pivotal trial to demonstrate improved quality-of-life metrics |
PRO improvement over control |
|
| Refractive outcomes after trabecular micro-bypass stents (iStent inject) with cataract extraction in open-angle glaucoma13 | 1 month Retrospective 106 eyes |
Demonstrates refractive neutrality in combination cataract procedures |
99% of eyes ≤1.0 D of target |
| Title | Author(s) | Study Details | Distinguishing Feature | Key Findings |
|---|---|---|---|---|
| Endothelial safety profile of minimally invasive glaucoma surgery stents14 Presented at AAO 2022 |
5 years Prospective |
Long-term safety data |
Proportion of Eyes >30% Endothelial Cell Loss at Post-op Month 60
Treatment Group
Control Group |
| Title | Author(s) | Study Details | Distinguishing Feature | Key Findings |
|---|---|---|---|---|
| Comparative study of 2-year outcomes for Hydrus or iStent inject microinvasive glaucoma surgery implants with cataract surgery15 | 2 years Registry 150 eyes |
First comparative data using propensity matching |
iStent inject®
Hydrus |
|
| Prospective interventional cohort study of ocular surface disease changes in eyes after trabecular micro-bypass stent(s) implantation (iStent or iStent inject) with phacoemulsification16 | 3 months Prospective 47 eyes |
Evidence for improved ocular surface health with iStent inject® |
Mean OSDI improvement: 56% |
| Title | Author(s) | Study Details | Distinguishing Feature | Key Findings |
|---|---|---|---|---|
| Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results17 | 8 years Retrospective 62 eyes |
Longest follow-up of any MIGS device (2x iStent®) |
Mean post-op IOP: 14.2 mmHg |
References
1. Sarkisian SR Jr, Grover DS, Gallardo M, et al; iStent infinite Study Group. Effectiveness and safety of iStent infinite trabecular micro-bypass for uncontrolled glaucoma. J Glaucoma. 2023;32(1):9-18. 2. Hengerer FH, Auffarth G, Conrad-Hengerer I. Sustained 7-year glaucoma control after second-generation trabecular micro-bypass with or without cataract surgery. Abstract presented at: Annual Meeting of the American Society of Cataract and Refractive Surgery; May 5-8, 2023; San Diego, CA. 3. Salimi A, Watt H, Harasymowycz P. Three-year outcomes of second-generation trabecular micro-bypass stents (iStent inject) with phacoemulsification in various glaucoma subtypes and severities. J Glaucoma. 2021;30(3):266-275. 4. Samuelson TW, Sarkisian SR Jr, Lubeck DM, et al; iStent inject Study Group. Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract: two-year results. Ophthalmology. 2019;126(6):811-821. 2021;30(3):266-275. 5. Singh IP, Sarkisian S Jr, Hornbeak D, Katz LJ, Samuelson T. Treatment success across different levels of preoperative disease burden: stratified two-year outcomes from the pivotal trial of iStent inject® trabecular micro-bypass in primary open-angle glaucoma and cataract. Clin Ophthalmol. 2021;15:3231-3240. 6. Clement C, Howes F, Ioannidis A, et al. Multicenter effectiveness and disease stability through 3 years after iStent trabecular micro-bypass with phacoemulsification in glaucoma and ocular hypertension. Clin Ophthalmol. 2022;16:2955-2968. 7. Samuelson TW, Singh IP, Williamson BK, et al. Quality of life in primary open-angle glaucoma and cataract: an analysis of VFQ-25 and OSDI from the iStent inject® pivotal trial. Am J Ophthalmol. 2021;229:220-229. 8. Ioannidis AS, Töteberg-Harms M, Hamann T, Hodge C. Refractive outcomes after trabecular micro-bypass stents (iStent Inject) with cataract extraction in open-angle glaucoma. Clin Ophthalmol. 2020;14:517-524. 9. Samuelson TW, Ahmed IK, De Francesco T, Sheybard A. Endothelial safety profile of minimally invasive glaucoma surgery stents. Poster presented at: Annual Meeting of the American Academy of Ophthalmology; September 30-October 3, 2022; Chicago, IL. 10. Holmes DP, Clement CI, Nguyen V, et al. Comparative study of 2-year outcomes for Hydrus or iStent inject microinvasive glaucoma surgery implants with cataract surgery. Clin Exp Ophthalmol. 2022;50(3):303-311. 11. Schweitzer JA, Hauser WH, Ibach M, et al. Prospective interventional cohort study of ocular surface disease changes in eyes after trabecular micro-bypass stent(s) implantation (iStent or iStent inject) with phacoemulsification. Ophthalmol Ther. 2020;9(4):941-953. 12. Salimi A, Watt H, Harasymowycz P. Long-term outcomes of two first-generation trabecular microbypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results. Eye Vis (Lond). 2021;8(1):43. 13. Gallardo MJ, Supnet RA. Three-year outcomes of combined trabecular micro-bypass and phacoemulsification in a predominantly Hispanic population with primary open-angle glaucoma. Clin Ophthalmol. 2019;13:869-879. 14. Samuelson TW, Ahmed IK, De Francesco T, Sheybard A. Endothelial safety profile of minimally invasive glaucoma surgery stents. Poster presented at: Annual Meeting of the American Academy of Ophthalmology; September 30-October 3, 2022; Chicago, IL. 15. Holmes DP, Clement Cl, Nguyen V, et al. Comparative study of 2-year outcomes for Hydrus or iStent inject microinvasive glaucoma surgery implants with cataract surgery. Clin Exp Ophthalmol. 2022;50(3):303-311. 16. Schweitzer JA, Hauser WH, Ibach M, et al. Prospective interventional cohort study of ocular surface disease changes in eyes after trabecular micro-bypass stent(s) implantation (iStent or iStent inject) with phacoemulsification. Ophthalmol Ther. 2020;9(4):941-953. 17. Salimi A, Watt H, Harasymowycz P. Long-term outcomes of two first-generation trabecular microbypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results. Eye Vis (Lond). 2021;8(1):43.
iDose TR IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE. iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). IMPORTANT SAFETY INFORMATION. Dosage and Administration. For ophthalmic intracameral administration. The intracameral administration should be carried out under standard aseptic conditions. Contraindications. iDose TR is contraindicated in patients with active or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity to travoprost or to any other components of the product. Warnings and Precautions. iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent. Adverse Reactions. In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity. Please see full Prescribing Information at www.glaukos.com. You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also call Glaukos at 1-888-404-1644.
iStent infinite® IMPORTANT SAFETY INFORMATION
INDICATION FOR USE. The iStent infinite® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. CONTRAINDICATIONS. The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite is MR- Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
iStent inject® W IMPORTANT SAFETY INFORMATION
INDICATION FOR USE. The iStent inject® Trabecular Micro-Bypass System Model G2-W is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma. CONTRAINDICATIONS. The iStent inject W is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent inject W is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject W have not been established as an alternative to the primary treatment of glaucoma with medications, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents. ADVERSE EVENTS. Common postoperative adverse events reported in the iStent inject® randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%). CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
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©2026 Glaukos Corporation. All rights reserved. iStent, iStent infinite, iStent inject W, iStent inject, and iDose TR are registered trademarks of Glaukos Corporation. PM-US-1413