Glaukos reports positive study results for iDose TR, iStent infinite
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.