The Australian Therapeutic Goods Administration (TGA) has granted approval for Glaukos' iStent Inject Trabecular Micro-Bypass Stent.
Approval allows Glaukos to use the iStent Inject in Australia in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate glaucoma that is currently treated with ocular hypotensive medication.
Glaukos president Thomas Burns said: "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.
"This approval strengthens our offering to Australian surgeons and patients, and underscores our commitment to expand our presence in the Asia Pacific region."
Packaged in a two-stent, preloaded, auto-inject mechanism, the iStent Inject enables an ophthalmic surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point for greater IOP reduction.
The inject is made from surgical grade non-ferromagnetic titanium that is coated with heparin, and is approximately 0.3mm in diameter and 0.4mm long, or roughly one-third the size of the original iStent.
The iStent inject uses a similar fluidic method of action as the company's flagship iStent Trabecular Micro-Bypass Stent, which was approved by the TGA in 2014.
As it is already approved in the European Union, the inject is currently being rolled out in Germany.
Glaukos is seeking regulatory approval in other countries, including the US where IDE clinical trials are on to test two versions of the inject, one along with cataract surgery and another as a stand-alone procedure in phakic and pseudophakic glaucoma patients.
Glaucoma is characterised by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage.
According to Glaucoma Australia, more than 300,000 Australians are suffering from the disease that cannot be cured and the only proven treatment is reduction of IOP.
Image: iStent inject is preloaded with two stents, each measuring approximately 0.3mm in diameter and 0.4mm long. Photo: courtesy of Business Wire.