Glaukos announced that its travoprost intraocular implant with the iDose delivery system continued to provide sustained reduction in IOP in a 12-month interim cohort of patients in its US investigational new drug phase 2 clinical trial, according to a company news release. Implanted during a microinvasive procedure, the iDose Travoprost is filled with a special formulation of travoprost and is designed to continuously elute therapeutic levels of the medication from within the eye for extended periods of time. When depleted, the iDose Travoprost can be removed and replaced in a similar procedure.
The multicenter, randomized, double-masked phase 2 trial included 154 patients. It was designed to evaluate two models of the iDose delivery system with two different travoprost elution rates compared with topical timolol ophthalmic solution 0.5% and had a primary efficacy endpoint of noninferiority to topical timolol.
The latest phase 2 results are from an interim cohort of 74 patients, 49 of whom were implanted with one of the iDose Travoprost implant models, with 25 patients in the timolol comparator group. In the implant patients, iDose Travoprost achieved an approximate 30% reduction in mean IOP versus baseline IOP during the first 12 months. In addition, the mean number of glaucoma medications ranged from 0.54 to 0.56 at 12 months in the fast and slow iDose Travoprost elution implant groups, respectively, compared with a mean 0.72 medications in the timolol group.
The most recent phase 2 data showed a favorable safety profile for iDose Travoprost with no adverse events of hyperemia reported to date in either elution group, the news release said.