Ophthalmic pharmaceutical and medical technology company Glaukos Corporation (NYSE:GKOS) on Friday announced positive topline results from its Phase 4 GLK-101-04 clinical trial evaluating iDose TR in combination with cataract surgery in patients with open-angle glaucoma or ocular hypertension.
The study met its primary efficacy endpoint, with the combination delivering a mean diurnal intraocular pressure (IOP) reduction of 11.1 mmHg at three months, compared with 7.4 mmHg for cataract surgery alone, representing a statistically significant difference of 3.6 mmHg.
iDose TR also demonstrated statistically significant superiority across all prespecified secondary responder analyses and a favourable safety profile through three months, with no treatment-related corneal endothelial cell loss, cystoid macular oedema or serious corneal adverse events.
The randomised, double-masked trial included 149 study eyes, with 74 assigned to the combination treatment group and 75 to cataract surgery alone.
iDose TR is an intracameral therapy designed to deliver therapeutic levels of travoprost continuously for up to three years, with the aim of addressing patient non-adherence and chronic side effects associated with topical glaucoma medications.
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