Clinical Data for iStent inject^® W

Micro Stents. Macro Efficacy.

iStent inject^® W builds on the trabecular micro-bypass technology of iStent inject^®, which has demonstrated efficacy across a wide range of clinical studies.

US Pivotal Trial at 24 Months¹

In the US IDE Trial (n=505 subjects), iStent inject^® met all study endpoints and demonstrated a clinically significant reduction in IOP for iStent inject^® subjects at 24 months.

• 75.8% of iStent inject^® subjects had ≥ 20% reduction in unmedicated DIOP
• 7.0 mm Hg reduction from baseline in unmedicated DIOP

Other Observed Data:

• 17.1 mm Hg mean medication-free IOP at 24 months
• 63.2% medication-free DIOP ≤ 18 mm Hg at 24 months
• Mean of 0.4 medications at 23 months, down from preoperative mean of 1.6 for the treatment arm

---

Independent Clinical Study Results

Additional independent, long-term studies of Glaukos trabecular micro-bypass technology suggest that results are maintained several years after the procedure.

Long-term IOP Reduction ⁵

In a consecutive case series with three-year follow-up, mean IOP was 14.3 ± 1.7 mm Hg, representing a 37% reduction from preoperative medicated mean IOP of 22.6 ± 6.2 mm Hg; and 100% of eyes had IOP ≤ 18 mm Hg.

Sustained Medication Reduction⁵

In the same consecutive case series, mean medication use was decreased from 2.5 to 0.8 medications at three years, a 68% reduction; and 74% of eyes were using 0 or 1 medication compared to 21% preoperatively.

---

Safety

In the US IDE pivotal study, iStent inject^® had no reports of hypotony, significant hyphema, flat anterior chamber, choroidal hemorrhage or effusion, or myopic shift.^1,6

Medication reduction is subject to the discretion of the physician.

1. Samuelson TW, Sarkisian SR, Lubeck DM, et al. Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract. Ophthalmology. Jun 2019;126(6):811-821.
2. Guedes RAP, Gravina DM, Lake JC, Guedes VMP, Chaoubah A. Intermediate results of iStent^® or iStent inject^® implantation combined with cataract surgery in a real-world setting: a longitudinal retrospective study. Ophthalmol Ther. March 2019;8(1):87-100.
3. Clement CI, Howes F, Ioannidis AS, Shiu M, Manning D. One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study. Clin Ophthalmol. 2019:13;491-499.
4. Manning D. Real-world case series of iStent^® or iStent inject^® trabecular micro-bypass stents combined with cataract surgery. Ophthalmology & Therapy. 2019. doi:https://doi.org/10.1007/s40123-019-00208-x.
5. Hengerer FH. Personal experience with second-generation trabecular micro-bypass stents in combination with cataract surgery in patients with glaucoma: 3-year follow-up. ASCRS 2018 Presentation.
6. Arriola-Villalobos P, Martinez-de-la-Casa JM, Diaz-Valle D, et al. Glaukos iStent inject^® trabecular micro-bypass implantation associated with cataract surgery in patients with coexisting cataract and open-angle glaucoma or ocular hypertension: a long-term study. J Ophthalmology. 2016;1-7.

Important Safety Information »