Glaukos completes enrollment in phase 3 program for iDose TR
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Glaukos is moving forward with an FDA new drug application phase 3 clinical program for the iDose TR after finishing patient enrollment and randomization, according to a press release.
“We are excited to announce this important milestone for iDose TR, marking a critical step in bringing this promising technology one step closer to being able to safely provide sustained glaucoma pharmaceutical therapy and tackle the significant problem of patient nonadherence to topical glaucoma medication regimens,” Thomas Burns, Glaukos president and CEO, said in the release.
Two prospective, randomized, double-masked trials are designed to compare travoprost delivered in a single administration vs. topical timolol ophthalmic solution 0.5% twice daily in 1,150 subjects with open-angle glaucoma or ocular hypertension. Two different travoprost release rates will be studied.
Primary efficacy endpoint at 3 months is noninferiority to topical timolol, and safety evaluations up to 12 months are planned.
“We look forward to following these patients’ outcomes as we target U.S. NDA submission in 2022 and FDA approval in 2023,” Burns said in the release.
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