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Australia to have first access to glaucoma device

15/08/2018By Matthew Woodley
Australia has become the first global market to gain access to a new type of minimally invasive glaucoma surgery (MIGS) device.

The Hydrus Microstent, designed to lower eye pressure for open-angle glaucoma patients, has been approved for use in Australia since 2013. However, its developer Ivantis chose to collect clinical data via a select group of surgeons who trialled its use under a registry study profile before taking it to market.

“We were building a database of clinical results in order to provide some real-world outcomes into the market when we launched,” managing director for Ivantis Asia Pacific, Mr Glen Burgess said.

“I use them quite frequently in people with mild, moderate and even sometimes advanced glaucoma.”
Graham Hay-Smith, Moreton Day Hospital

“We’ve since been granted prosthetics benefits listing approval so that patients can claim the product through private insurance and we received our first order last week.”

One of the local ophthalmologists involved in the trial was Dr Graham Hay-Smith, who estimated he had implanted around 150 of the devices over the past three years. Hay-Smith told Insight he was attracted to the safety profile of the Hydrus in comparison to more invasive procedures such as trabeculectomies.

“Although trabeculectomies are a good operation at a population level, it can be a very poor operation for the individual. It has high complications rates – I think it’s 23% back in hospital within the first three years as an unplanned emergency surgery,” Hay-Smith said.

“I emphasise to patients the lack of efficacy compared to trabeculectomy, but I think their safety profile is so high in comparison that I use them quite frequently in people with mild, moderate and even sometimes advanced glaucoma for patients for whom a trabeculectomy is no longer indicated.

“It’s not as effective as a shunt, or a tube, or a trabeculectomy, but they are effective – they do reduce pressures, sometimes quite markedly and particularly sometimes with tricky cases.”

Hay-Smith recently opened the Moreton Day Hospital in Brisbane, and he said working in private practice had also emphasised the potential benefits of the device.

“For a lot of surgeons like myself who are primarily in private practice without access to the full support of an eye emergency team, trabeculectomies are something that you don’t embark on lightly,” he explained.

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“We don’t know the long term results yet, we don’t know to what degree we may regret in the future using these devices, but it’s the same with them all, and I think that they just fit very well into my practice.”

FDA approval for the device was granted earlier this week, which will also see it commercialised in the US in the near future. Approval was based on the HORIZON Trial, which found 77% of patients in the Hydrus Microstent group achieved a statistically significant decrease of ≥20% reduction in unmedicated intraocular pressure at 24-months postoperative.

More reading: 

Australian first rural MIGS surgery a success

Ophthalmologists lobby minister over MIGS access

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