Glaukos, an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, today announced that the U.S. Food and Drug Administration (FDA) is allowing the company to move forward with activities to begin a U.S. Investigational New Drug (IND) Phase II study of its Travoprost Intraocular Implant with the iDose™ delivery system in patients with glaucoma.
Injected through a clear corneal incision and secured in the anterior chamber, the iDose is designed to continuously elute therapeutic levels of medication from within the eye for extended periods of time. The titanium implant is comparable in size to the company’s proprietary Micro-Invasive Glaucoma Surgery (MIGS) devices.
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 procedure. Glaukos has designed the product to be an alternative to chronic, daily prescription eye drop treatments, which are subject to high rates of patient non-compliance and may cause long-term ocular surface damage in glaucomatous eyes.
The open IND for the Phase II trial follows Glaukos’ recently announced IND submission to the agency in which the company proposed to conduct a randomized trial to assess the safety and preliminary efficacy of two models of the iDose delivery system with different travoprost elution rates compared to a topical timolol maleate ophthalmic solution, 0.5%.
"We are very pleased that the FDA is allowing this trial to begin several months in advance of our original target date," said Thomas Burns, president and CEO of Glaukos. "We believe the iDose platform has the potential to address important unmet clinical needs by overcoming the significant issue of patient non-compliance with chronic prescription eye drop regimens, and reducing risk of ocular surface damage and other side effects associated with repeated applications of topical drugs."
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 IOP is the only proven treatment. According to Market Scope, more than 80 million people worldwide have glaucoma, including approximately 4.3 million people in the United States. Open-angle glaucoma is the most common form, affecting approximately 3.5 million people in the United States.