The company’s iDose device is placed during a micro-invasive procedure and filled with a special formulation of travoprost – a drug used to reduce intraocular pressure. The implant continuously delivers therapeutic levels of travoprost within the eye and when it’s depleted, the iDose is removed and replaced.
The company’s 154-patient trial evaluated two models of the iDose delivery system with two travoprost elution rates. The device was compared to a 0.5% topical timolol ophthalmic solution and Glaukos set a primary efficacy endpoint of non-inferiority to the topical product.
The latest results are from an interim cohort of 74 patients, with 49 of them having received one of the iDose implant models and 25 having received the topical timolol. Patients who received the iDose implant experienced a 30% reduction in mean intraocular pressure compared to baseline.
Glaukos also reported that the mean number of glaucoma medications patients were taking in the iDose groups after 12 months ranged from 0.54 – 0.56, compared to 0.72 mean medications in the timolol group.
“These latest Phase II results further underscore the potential of iDose Travoprost to provide many months of sustained glaucoma pharmaceutical therapy and tackle the significant problem of patient non-adherence to topical medication regimens,” Thomas Burns, Glaukos president and CEO, said in prepared remarks.
“We are pleased to be working cooperatively with the FDA as we prepare for the Phase III trial, which will mark another critical step forward in the advancement of our novel and comprehensive product pipeline designed to transform glaucoma therapy.”
The company’s Phase III IND trial is slated to enroll 1,000 ocular hypertensive or open-angle glaucoma patients.
Glaukos also announced today that it is gearing up for regulatory approvals in Europe and Japan for the iDose travoprost.