Medical technology firm Glaukos has closed enrollment in its US Food and Drug Administration (FDA) investigational device exemption (IDE) trial of iStent SUPRA Suprachoroidal Micro-Bypass Stent for the treatment of glaucoma and cataract.
The 4mm in length and curved iStent SUPRA is developed to decrease the intraocular pressure (IOP) by accessing the suprachoroidal space in the eye.
The prospective, randomised clinical trial will evaluate the stent in 505 participants with mild-to-moderate open-angle glaucoma and cataracts.
The primary objective of the trial is to achieve 20% or greater decrease in intraocular pressure (IOP) from baseline over a period of 24 months. Based on the results from this trial, the firm intends to submit for a pre-market approval (PMA) to the FDA.
Glaukos president and chief executive officer Thomas Burns said: “We expect the iStent SUPRA to ultimately be an important part of ophthalmic surgeons’ armamentarium for effectively managing IOP.
“Achieving this enrollment milestone represents an important step forward in our goal to provide surgeons and their patients a comprehensive set of options to address a range of glaucoma disease state and progression.”
iStent SUPRA is currently approved for marketing in the European Union and certain other countries outside the US.
In 2012, the firm has introduced iStent Trabecular Micro-Bypass Stent to perform micro-invasive glaucoma surgery by accessing the suprachoroidal space for aqueous humor outflow through the trabecular meshwork and into Schlemm’s canal.
Glaukos is conducting FDA clinical trials of the iStent inject Trabecular Micro-Bypass Stent, for its use in combination with cataract surgery and as a standalone procedure.
Image: iStent. Photo: courtesy of Glaukos Corporation.
