Glaukos Submits IND Application to FDA to Study iDoseTM Travoprost Intraocular Implant in Glaucoma Patients
Company Seeks to Conduct Phase II Clinical Trial to Assess Implant’s Safety and Preliminary Efficacy for Reduction of Elevated Intraocular Pressure
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Glaukos Corporation (NYSE: GKOS), 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 it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) seeking authorization to study its Travoprost Intraocular Implant with the iDoseTM delivery system for investigational use in the reduction of elevated intraocular pressure (IOP) in patients with glaucoma.
“We believe this micro-scale implant may be a viable answer to the ubiquitous and long-standing problem of patient non-compliance with prescription eye drops and we look forward to working cooperatively with the FDA as they review our IND submission.”
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. The implant is capped with a membrane that is 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 may have high rates of patient non-compliance and cause long-term ocular surface damage to glaucomatous eyes.
“This IND submission represents a seminal milestone, which the Glaukos team achieved well ahead of our original 2016 timeline,” said Thomas Burns, president and CEO of Glaukos. “We believe this micro-scale implant may be a viable answer to the ubiquitous and long-standing problem of patient non-compliance with prescription eye drops and we look forward to working cooperatively with the FDA as they review our IND submission.”
In the IND application, Glaukos proposes to conduct a randomized Phase II clinical trial to assess the safety and preliminary efficacy of two models of the iDose delivery system with different travoprost elution rates compared to topical timolol maleate ophthalmic solution, 0.5%. The Phase II study is proposed to be unmasked at 12 weeks. The IND application includes information on travoprost’s history of safety and efficacy, as well as Glaukos’ preclinical program and early data from an initial international clinical trial on the implant involving 69 patients……
source: Business Wire