Published on 7 Sep 2022 on Benzinga via Yahoo Finance
Glaukos Corporation (NASDAQ: GKOS) announced positive topline data for both Phase 3 trials of iDose TR. It achieved its pre-specified primary efficacy endpoints through 3 months and demonstrated excellent tolerability and a favorable safety profile through 12 months.The fast- and slow-release iDose TR arms achieved the primary efficacy endpoint of non-inferiority to the active comparator arm (topical timolol ophthalmic solution).Related: Glaukos Inks Licensing Pact For Rare Eye Disorder Treatment.For the GC-010 trial, the intraocular pressure (IOP) reductions from baseline were 6.6-8.5 mmHg in the slow-release iDose TR arm versus 6.6-7.7 mmHg in the timolol control arm.For the GC-012 trial, IOP reductions were 6.7-8.4 mmHg in the slow-release iDose TR arm versus 6.8-7.2 mmHg in the timolol control arm.93% of slow-release iDose TR subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 12 months compared to screening after a single administration of iDose TR, versus 67% of timolol control subjects.Additionally, 81% of slow-release iDose TR subjects were completely free of IOP-lowering topical medications.iDose TR demonstrated a favorable safety profile.Glaukos plans to move forward with its plans for marketing application submission to the FDA for the slow-release iDose TR model, with an expected FDA review and decision completed by the end of 2023.Price Action: GKOS shares are up 16.80% at $56.16 on the last check Wednesday.
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