iDose TR
- Indication
- Glaucoma
- Stage
- phase6
- Event
- Topline Data
- Details
October 9, 2026: Glaukos (NYSE: GKOS) reported positive topline Phase 4 results from GLK-101-04 evaluating iDose TR plus cataract surgery versus cataract surgery alone in adults with open-angle glaucoma or ocular hypertension.
The prospective, multicenter, randomized, double-masked trial enrolled 149 study eyes (74 in the iDose TR combination arm; 75 in cataract surgery alone). The study met its primary endpoint: at month 3, mean diurnal intraocular pressure (IOP) fell 11.1 mmHg from baseline with iDose TR plus cataract surgery versus 7.4 mmHg with cataract surgery alone, for an incremental treatment effect of 3.6 mmHg (p<0.0001). iDose TR also showed statistically significant superiority across all pre-specified secondary responder analyses.
Safety through 3 months was described as favorable, with no treatment-related adverse events of corneal endothelial cell loss or cystoid macular edema and no serious corneal adverse events. The company said overall safety was consistent with prior iDose TR experience.
The release also notes iDose TR is already approved in the U.S. for a single administration to reduce IOP in patients with open-angle glaucoma or ocular hypertension.
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