Glaukos Corporation announced the completion of patient enrollment in the investigational new drug (IND) phase 2 study of its Travoprost intraocular implant with the iDose delivery system in patients with glaucoma.
Implanted during a micro-invasive procedure, the iDose is designed to continuously elute therapeutic levels of medication from within the eye for extended periods of time. It is filled with a special formulation of travoprost, a prostaglandin analog used to reduce elevated intraocular pressure, and capped with a membrane designed for continuous controlled drug elution into the anterior chamber. When depleted, the implant can be removed and replaced in a similar, subsequent micro-invasive procedure.
The 150-patient, multicenter, randomized, double-blind phase 2 trial will evaluate two models of the iDose delivery system with different travoprost elution rates compared to a topical timolol maleate ophthalmic solution, 0.5%. The trial, which will assess preliminary safety and efficacy in lowering IOP in patients with open-angle glaucoma, will be unmasked after 12 weeks of follow-up, with a topline readout expected later in 2017. Results of the phase 2 trial are expected to form the basis for the company’s submission to the FDA to conduct expanded phase 3 trials on the iDose delivery system.
“Our completion of patient enrollment in the iDose phase 2 trial means that we have achieved an important and timely milestone in our goal to provide glaucoma patients and their physicians a comprehensive set of micro-scale devices and drug-delivery systems that address a full range of glaucoma disease state progression,” Thomas Burns, Glaukos president and chief executive officer, said in a company news release. “We believe that the iDose delivery system has the potential to overcome many of the drawbacks associated with topical glaucoma medications. We look forward to these initial trial results and to moving towards commencement of phase 3 clinical trials to determine the longer-term efficacy of our novel iDose delivery system.”
Glaukos designed the iDose to be an alternative to chronic, daily prescription eye drop therapy, which is subject to high rates of patient non-compliance and may cause long-term ocular surface irritation or damage in glaucomatous eyes. The titanium implant is comparable in size to the company’s proprietary micro-Invasive glaucoma surgery (MIGS) devices.