A sustained reduction in IOP was seen in a 12-month interim cohort of patients in an investigational new drug phase 2 clinical trial of the travoprost intraocular implant with the iDose delivery system, Glaukos announced in a press release.
The iDose travoprost is filled with a formulation of travoprost and implanted during a microinvasive procedure. It was studied in 154 patients in the multicenter, randomized, double-masked phase 2 trial, which was designed to evaluate two models of the delivery system with two different travoprost elution rates compared with topical timolol ophthalmic solution 0.5%.
An interim cohort of 74 patients, 49 of whom received the iDose travoprost, showed an average IOP reduction of approximately 30% from baseline at 12 months. The mean number of glaucoma medications ranged from 0.54 to 0.56 in the fast and slow elution groups, respectively, compared with 0.72 in the timolol group. Hyperemia was not reported in either elution group.
The company held an end-of-phase 2 meeting with the FDA in late 2017 and is planning to begin a phase 3 IND clinical trial that will enroll 1,000 ocular hypertensive or open-angle glaucoma subjects in the first half of the year, according to the release.
Glaukos also announced it has begun the process to seek regulatory approvals for iDose travoprost in European markets and Japan.