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Glaukos Corporation (NYSE:GKOS), a MedTech company focused on eye diseases, announced Wednesday its eye implant, iDose TR, reached primary efficacy endpoints in two pivotal trials involving patients with open-angle glaucoma (OAG) or ocular hypertension.
iDose TR contains a new formulation of travoprost, a treatment used to reduce intraocular pressure (IOP), offering an alternative to daily eye drop treatment.
The randomized, double-masked Phase 3 studies called GC-010 and GC-012 enrolled 1,150 subjects who were part of the slow-release iDose TR arm, fast-release iDose TR arm, and the active comparator arm (twice-daily topical timolol ophthalmic solution).
Topline results indicate that both trials reached the pre-specified primary efficacy endpoint for both fast- and slow-release iDose TR arms showing non-inferiority to the active comparator arm through three months.
Notably, 93% of subjects in the slow-release iDose TR in both trials remained well-controlled with the same or less IOP-lowering topical medications at 12 months compared to 67% in the active comparator arm. 81% slow-release iDose TR were free of IOP lowering topical agents at 12 months.
While 3% of slow-release iDose TR subjects experienced conjunctival hyperemia, 98% of slow-release iDose TR subjects continued the trials at 12 months versus 95% of timolol subjects.
GKOS plans to submit a marketing application to the FDA for the slow-release iDose TR model expecting a decision on the review by the end of 2023.
Read: GKOS reported a mixed performance with its Q2 2022 results last month.