Glaukos announced the completion of patient enrollment and randomization in its FDA new drug application (NDA) phase 3 clinical trials for the iDose TR sustained-release travoprost implant.
The iDose TR phase 3 clinical program consists of two prospective, randomized, double-masked clinical trials designed to compare the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates to topical timolol ophthalmic solution, 0.5% BID (twice a day), in reducing elevated intraocular pressure (IOP) in subjects with open-angle glaucoma (OAG) or ocular hypertension. The primary efficacy endpoint of the phase 3 studies is noninferiority comparison to topical timolol 0.5% BID over the first 3 months, and safety evaluations for up to 12 months. The phase 3 trials randomized a total of 1,150 subjects across 89 clinical sites, the majority of which are in the United States. The 12-month iDose TR Phase 3 trial results are expected to support Glaukos’ targeted NDA submission in 2022 and FDA approval for iDose TR in 2023.
“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 non-adherence to topical glaucoma medication regimens,” Thomas Burns, Glaukos president and chief executive officer, said in a company news release. “We appreciate the commitment and dedication of the clinical investigators, who play a vital role in bringing new innovations to patients suffering with glaucoma disease. We look forward to following these patients’ outcomes as we target U.S. NDA submission in 2022 and FDA approval in 2023.”
Administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to reduce IOP, and was designed to continuously release therapeutic levels of the medication for at least 1 year. Once all travoprost is released, the iDose TR was designed to be removed and replaced with a new iDose TR, thus offering an alternative to daily eye drop treatment.