Glaukos Corp GKOS shares are trading higher by 1.87% to $49.00 Wednesday morning after the company announced topline data for both Phase 3 pivotal trials of iDose TR that successfully achieved its pre-specified primary efficacy endpoints through 3 months in both Phase 3 trials and demonstrated excellent tolerability and a favorable safety profile through 12 months.
What Else?
Based on the combined efficacy and safety results from both Phase 3 pivotal trials, Glaukos plans to move forward with its plans for an NDA submission to the U.S. FDA for the slow-release iDose TR model, with an expected FDA review and decision completed by the end of 2023.
Administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to reduce IOP. Once all travoprost is released, the iDose TR was designed to be removed and replaced with a new iDose TR, thus potentially offering an alternative to daily eye drop treatment.
According to data from Benzinga Pro, Glaukos has a 52-week high of $64.49 and a 52-week low of $33.33.
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