iDose TR shows continued IOP reduction, safety at 36 months
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The iDose TR demonstrated sustained IOP reduction at 36 months, according to a press release from Glaukos.
The multicenter, randomized, double-masked, phase 2b clinical trial enrolled 154 patients. Fifty-one patients received fast-release iDose TR (sustained-release travoprost implant), 54 received slow-release iDose TR, and 49 received timolol twice daily. The primary efficacy endpoint was noninferiority compared with timolol following a single iDose TR administration.
Seventy percent of patients in the fast-release arm and 68% of patients in the slow-release arm were well controlled at 36 months compared with 46% of patients in the timolol arm. In the patients who were considered well controlled, those in the fast-release arm experienced an average IOP reduction of 8.3 mm Hg IOP from baseline to 36 months, those in the slow-release arm experienced an average IOP reduction of 8.5 mm Hg, and those in the timolol arm experienced an average IOP reduction of 8.2 mm Hg.
“These latest phase 2 results further underscore the potential of iDose TR to safely provide multiple years of sustained dropless therapy and help tackle the significant problem of patient nonadherence to and chronic side effects associated with topical glaucoma medication regimens,” Thomas Burns, president and CEO of Glaukos, said in the release.
The 36-month data reinforced previous favorable safety data, with “no clinically significant corneal endothelial cell loss, no serious corneal adverse events and no adverse events of periorbital fat atrophy and conjunctival hyperemia reported to date in either elution arm,” the release said.
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