Glaukos Completes Patient Enrollment in Phase II Clinical Trial for iDose Travoprost Implant

Glaukos Corporation, an ophthalmic medical technology company focused on the development and commercialization of glaucoma treatment products and procedures, has completed patient enrollment in the U.S. Investigational New Drug (IND) Phase II study of its Travoprost Intraocular Implant with the iDose delivery system in glaucoma patients.
 
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, multi-center, randomized, double-blind Phase II 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 percent. The trial, which will assess preliminary safety and efficacy in lowering intraocular pressure 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 II trial are expected to form the basis for the company’s submission to the U.S. Food and Drug Administration (FDA) to conduct expanded Phase III trials on the iDose delivery system.
 
“Our completion of patient enrollment in the iDose Phase II 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,” said Thomas Burns, Glaukos president and CEO. “We believe 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 III 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.
 
Glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing intraocular pressure is the only proven treatment. According to Market Scope, more than 80 million people worldwide have glaucoma, including 4.5 million people in the United States. Open-angle glaucoma is the most common form, affecting approximately 3.6 million people in the United States.
 
Glaukos is an ophthalmic medical technology company that develops and commercializes glaucoma treatment products and procedures. The company pioneered MIGS to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent Trabecular Micro-Bypass Stent, its first MIGS device, in the United States in July 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent, measuring 1.0 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA.