Press Releases

January 13, 2021
1 min read

Glaukos reports positive study results for iDose TR, iStent infinite


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Two IOP reduction methods from Glaukos showed favorable results and safety profiles in recent trials, according to company press releases.

The iDose TR sustained-release travoprost implant provided substantial IOP reductions in an interim analysis of an ongoing 36-month phase 2b clinical trial, while the iStent infinite trabecular micro-bypass system showed substantial mean diurnal IOP reduction through 12 months.

The iDose TR was evaluated in a 154-subject, multicenter, randomized, double-masked trial designed to evaluate a single administration of one of two iDose TR models compared with twice-daily topical timolol ophthalmic solution 0.5%.

Participants were randomly assigned into fast-release iDose TR, slow-release iDose TR and timolol active comparator arms. Subjects in either iDose TR arm received a single intracameral implant, while those in the control arm received twice-daily eye drops over the 24-month period.

There was an average reduction in IOP from baseline of 7.9 mm Hg and 7.4 mm Hg in the fast- and slow-release arms, respectively, vs. 7.8 mm Hg in the control group.

The trial also demonstrated a favorable safety profile, with no clinically significant corneal endothelial cell loss, no serious corneal adverse events and no adverse conjunctival hyperemia events.

The iStent infinite demonstrated a substantial reduction in mean diurnal IOP in subjects with open-angle glaucoma in a 12-month investigational device exemption pivotal trial.

The prospective, unmasked, multicenter, single-arm clinical trial enrolled subjects who underwent previous unsuccessful incisional or cilioablative glaucoma surgery and were on maximally tolerated IOP-lowering medications but had uncontrolled IOP. The trial included 72 subjects who received the implant at 15 sites.

Subjects entered the study with a mean baseline IOP of 23.4 mm Hg, with an average of 3.1 medications and two failed surgeries. At 12 months, 76% of subjects had a 20% or greater reduction in mean diurnal IOP from baseline. More than 50% achieved an IOP reduction of 30% or more. Medication burden was reduced by 13%. The safety profile showed no explants, infections, device-related interventions or hypotony.

Glaukos is targeting U.S. approval of the iStent infinite in late 2021.

Read the full perspective from Carlos Buznego, MD.