Opthalmic medical technology firm Glaukos has completed the enrolment of patients in its US pivotal clinical trial of the iStent inject Trabecular Micro-Bypass Stent.
The company has designed iStent inject for ophthalmic surgeons to inject stents into multiple trabecular meshwork locations through a single corneal entry point.
Driven by an auto-inject mechanism for predictable and facile implantation, the iStent inject includes micro-needle that is preloaded with two stents.
Glaukos president and CEO Thomas Burns said: "Our completion of the iStent inject U.S. pivotal trial patient enrollment and the achievement of our patient randomization goal marks another milestone towards introducing breakthrough technologies that can advance glaucoma patient care."
The prospective and multicenter clinical trial has enrolled around 500 randomized subjects in 40 sites. In the study, subjects are randomized to either iStent inject in combination with cataract surgery or cataract surgery alone.
With a primary endpoint of a 20% or greater reduction in intraocular pressure from baseline, the trial protocol calls for randomized subjects to be followed for two years.
The study results will serve as basis for the firm’s pre-market approval (PMA) submission to the US Food and Drug Administration (FDA).
The firm is also carrying an initial US investigational device exemption (IDE) trial to assess a second version of the iStent inject to be used as a standalone procedure in glaucoma patients who are not undergoing concurrent cataract surgery, in addition to conducting an iStent inject US trail in combined cataract procedures.
The iStent inject has already received approval for commercial use in the European Union and Australia. The company is currently carrying an initial commercial launch of iStent inject in Germany.