Glaukos announced the regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its iStent inject Trabecular Micro-Bypass Stent.
With TGA approval, the iStent inject is now indicated for use in Australia in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate glaucoma currently treated with ocular hypotensive medication.
The iStent inject relies on a similar fluidic method of action as the company’s flagship iStent Trabecular Micro-Bypass Stent, which was approved by the TGA in 2014.
Packaged in a two-stent, preloaded, auto-inject mechanism, the iStent inject allows an ophthalmic surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point for greater IOP reduction.
Made from surgical-grade non-ferromagnetic titanium that is coated with heparin, each iStent inject stent is approximately 0.3 mm in diameter and 0.4 mm long, or roughly one-third the size of the original iStent.
"The iStent inject is designed to make it more straightforward for a surgeon to implant two stents in a facile click-and-release motion, providing an important new tool for effectively managing patients’ IOP," said Thomas Burns, president and CEO of Glaukos.
"This approval strengthens our offering to Australian surgeons and patients, and underscores our commitment to expand our presence in the Asia Pacific region."
According to Glaucoma Australia, a not-for-profit glaucoma awareness, education and support association, more than 300,000 people in Australia suffer from glaucoma, which is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing IOP is the only proven treatment.
The iStent inject is already approved in the European Union and an initial commercial launch is underway in Germany.
Glaukos is also pursuing regulatory approval in other countries, including the US where the company is conducting IDE clinical trials to evaluate two versions of the iStent inject, one in combination with cataract surgery and another as a standalone procedure in phakic and pseudophakic glaucoma patients.