Ophthalmic medical technology company Glaukos Corporation committed to the development of world-class products aiming to revolutionise the treatment of Glaucoma declared that it has successfully submitted an investigative Device exemption application to the U.S FDA attempting to seek permission to evaluate its iStent infinite Trabecular Micro- bypass system.
The iStent Infinite in itself is meant to alleviate intraocular pressure i n refractory glaucoma patients. Three heparin-coated titanium stents preloaded into an auto-injection system are enumerated allowing to administrate stents in a duration of 5 to 6 hours around schlemm’ss canal, the eye’s pertinent drainage canal. The stents are designed to assuage the IOP by reviving the physiological outflow of aqueous humor.
Thomas Burns, president and chief executive officer states “We look forward to working cooperatively with the FDA as they review our IDE application – an application that marks another milestone achievement towards our goal to deliver a comprehensive pipeline of micro-scale glaucoma devices and sustained therapy pharmaceuticals.”
The application submitted mentions the proposal to initate a multi- center trial to assess the safety and performance of the iStent infinite in 65 refractory subjects. The trial results will set the tone for seeking FDA clearance via a 510k pre-market submission.
The company’s first-generation iStent Trabecular Micro-Bypass Stent, which was approved by the FDA in 2012 cites an example for developing the iStent infinite that has significantly lowered IOP in adult cataract patients with mild-to-moderate open-angle glaucoma. Each iStent infinite stent is approximately 0.36 mm x 0.36 mm.
Glaucoma connotes irrevocable, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no tested cure for the disease and reducing IOP is the only proven treatment. Based on analysis of population-based surveys, medical claims data and other statistics, the company estimates that there are approximately 5.4 million people in the U.S. afflicted with the most common form i.e primary open-angle glaucoma.