iDose lowers IOP, shows no significant adverse events in phase 2 trial
SAN FRANCISCO — The iDose, a titanium implant from Glaukos for continuous drug delivery, has shown positive phase 2 results and is currently in a phase 3 program, according to a speaker here.
Designed to be an alternative to topical medications for the treatment of glaucoma, the iDose delivers a novel, uber-potent formulation of travoprost through an implant injected directly into the sclera via a preloaded injector system.
“In using the microfluidic delivery systems that we designed for the MIGS space, we have modified those to get into long-term drug delivery,” Jane Rady, Glaukos senior vice president, said at Glaucoma 360: New Horizons Forum.
A phase 2 study compared two elution rates of the iDose with topical timolol. Both iDose travoprost cohorts showed IOP reduction between 8 mm Hg and 8.5 mm Hg compared with an average reduction of 7.5 mm Hg in the timolol cohort.
“Both of the iDose cohorts had less medications required post-surgery than the timolol, 31% less, and there were no significant adverse events, no hyperemia in these patients,” Rady said. “The membrane is uniquely designed and the formulation such we can deliver a therapeutic dose of travoprost and eliminate the side effects associated with topical applications.”
A three-arm, sham-controlled phase 3 clinical trial of iDose is currently underway. Patients will be monitored for noninferiority to timolol at 3 months and safety at 12 months.
“We are very optimistic that they’re going to provide a duration that’s going to make this a clinically appropriate treatment for these patients,” Rady said. – by Rebecca L. Forand
Rady J. A novel, long-term, sustainable drug delivery platform. Presented at: Glaucoma 360: New Horizons Forum; Feb. 7, 2020; San Francisco.
Disclosure: Rady reports she is senior vice president of Glaukos.