Glaukos has submitted a supplemental premarket approval application to the US Food and Drug Administration (FDA) for its iStent infinite Trabecular Micro-Bypass System.
The investigational iStent infinite device is similar to the company’s two-stent iStent inject W Trabecular Micro-Bypass System, which received FDA approval to reduce elevated intraocular pressure (IOP) in adult mild-to-moderate primary open-angle glaucoma patients.
The iStent infinite can be used in a standalone procedure to minimise IOP in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy.
With three heparin-coated titanium stents preloaded into an auto-injection system, the device can be injected by the surgeon across a span of up to approximately six clock hours around the eye’s primary drainage channel known as Schlemm’s canal.
After they are injected, the stents will restore the natural, physiological outflow of aqueous humour by lowering IOP.
Glaukos president and CEO Thomas Burns said: “This filing marks a significant achievement for Glaukos as we continue to advance our deep pipeline of novel glaucoma surgical devices and sustained pharmaceuticals.
“Supported by strong pivotal data highlighting favourable safety and effectiveness, we believe iStent infinite may provide ophthalmic surgeons with a compelling new treatment alternative in a standalone procedure for patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy.”
For the iThe iStent infinite prospective, unmasked, multi-centre, single-arm clinical trial, the subjects that were enrolled had previously undergone either unsuccessful incisional or cilioablative glaucoma surgery.
A total of 72 subjects were implanted with the device at 15 separate clinical sites.
The study showed a favourable safety profile, and no explants, infections or device-related interventions or hypotony were reported over 12 months.
In June, the Therapeutic Goods Administration (TGA) of Australia approved Glaukos’ PRESERFLO MicroShunt for lowering intraocular pressure (IOP) in eyes of people with primary open-angle glaucoma.