WRITER Melanie Kell

Ten years ago, a small titanium device measuring just 360 microns in height began quietly revolutionising glaucoma treatment in Australia. The Glaukos iStent, the world’s smallest medical implant, introduced minimally invasive glaucoma surgery (MIGS) to Australian ophthalmologists and their patients, offering a paradigm shift in how the disease could be managed. In late 2025, Glaukos marked this milestone with an intimate dinner in Sydney, bringing together 12 pioneering ophthalmologists who have championed the technology since its earliest days. Over the course of an evening filled with reflection, discussion, and candid insights (along with a few laughs), these early adopters shared their experiences with three generations of the device and their vision for the future of glaucoma care.

More than the celebration of 10 years in the market, this was a story of courage, evidence, education, and a fundamental shift in thinking about when and how to intervene in glaucoma. From initial scepticism to current widespread acceptance, from first-generation single stents to the latest iStent infinite with three stents, the evening honoured continuous evolution, driven by surgeon feedback and robust research and development.

FROM FATHER’S QUESTION TO GLOBAL INNOVATION

The iStent’s inception came from a conversation between Dr Rick Hill, an ophthalmologist and professor at UC Irvine, and Olav Bergheim, the father of a patient who was living with severe glaucoma. When Dr Hill recommended a trabeculectomy, the father’s response was blunt, questioning trabeculectomy and asking if there was something less invasive.

Dr Hill had already been contemplating an alternative – a concept of intervening much earlier by bypassing the trabecular meshwork with tiny stents. However, he needed funding. And as chance would have it, Mr Bergheim was a venture capitalist. So, when Dr Hill explained he needed funding, the response was immediate and they started a company.

Mr Bergheim’s initial investment in 1998 eventually grew through multiple funding rounds to approximately US$118 million before the first commercial product launched 15 years later in 2013. Clinical need, innovative thinking, and patient-focused determination had combined to create what would become a new category in glaucoma surgery: minimally invasive glaucoma surgery, otherwise known as MIGS.

Glenn Fawcett joined Glaukos as the General Manager for Australia in September 2015, taking what he described as “one of the best risks of my life”. The faith he placed in the company was rewarded, and the team he assembled – including key members today, Malaty Kittikhoun and Sean Hutchings – formed the nucleus of what would become Glaukos’ successful Australian operation. The team in Australia has an average tenure in ophthalmology of almost 25 years and a deep commitment to eye health.

And they’ve contributed to global growth. From 150 employees in 2016, Glaukos now comprises over 1,000 team members. Ten years since commercialising the iStent, it has sold over 1.5 million devices.

SEEING BEYOND THE SCEPTICISM

The early days were not without challenges. Professor Paul Healey, who moderated the evening’s discussion, revealed that he implanted the very first iStent in Australia – in 2008, several years before commercial launch – as part of a trial with Professor Ivan Goldberg AM. “It was the first iStent in Australia,” Prof Healey recalled. “Glaukos was working with Ivan and, what was interesting to us, was the whole idea and the technology.”

With little technical support available in surgery, he and Prof Goldberg were left to work out how best to implant the fledgling device on their own.

That early experience came with the realisation that “a product isn’t going to do anything by itself until it’s accompanied by a process or a procedure”.

“Ivan summed it up beautifully. He said, ‘sometimes it worked beautifully and other times it didn’t work at all’.

“What makes a device work is the support for surgeons starting up (as they) familiarise themselves with the process.”

THE COMPANY THAT CHANGED EVERYTHING

When the Therapeutic Goods Administration first approved the iStent inject and it launched in Australia in 2016, it was for use 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.

Dr David Manning was among the very early adopters, having travelled to Armenia to use the commercially launched iStent inject before it was available in Australia. Dr Jason Cheng similarly gained experience, post-fellowship training in Canada, in Singapore and Armenia. However, Dr Cheng said, it was listening to Dr Frank Howes from Australia recount outcomes he’d achieved across 30 cases, and then auditing his own patient outcomes, that really convinced him of iStent’s enormous potential to fill an unmet need in glaucoma management.

Dr Nathan Kerr articulated that need: “For years, the mainstay of glaucoma treatment was an escalating number of glaucoma eye drops and surgery was viewed as a last resort. We had this really huge gap. While SLT (selective laser trabeculoplasty) was starting to come in too, surgically there was no intermediate option between drops and major surgery. The iStent filled that gap really nicely. Its safety profile enabled it to be used earlier – with minimal additional risk to cataract surgery alone.”

Describing the impact that the iStent has had on glaucoma surgery, Dr Colin Clement drew a parallel between Glaukos and other high-profile positive industry disruptors. “Glaukos has done for glaucoma what Apple did for the computer and Dyson did for the vacuum,” he said. “They saw something missing and decided to fill the gap. They decided to teach us why we needed to make a change, and they committed to the process. They’ve driven it with robust R&D, and with education and support. And they’ve been very confident in what they’re doing – they don’t try and protect the product, they let it speak for itself.”

This sentiment echoed throughout the room, with ophthalmologists consistently praising Glaukos’ approach to research, development, and surgeon support.

“I still remember Sean Hutchings, (Glaukos Area Director) coming with his crutches to support my first iStent case in Wollongong,” reflected Associate Professor Smita Agarwal. “Not many people have that level of dedication… The dedication you show and the support you give the surgeons and staff we have is just phenomenal.”

THREE ITERATIONS: LISTENING AND EVOLVING

Since its launch, the iStent has had four iterations: the iStent inject (G1) had one stent; the iStent inject (G2) and iStent inject W (G2W) had two stents, and the latest iteration – the iStent infinte (G3) – has three stents. And as Dr Judy Ku highlighted, each change has been based on surgeon feedback, and has come with no increase in price, maintaining accessibility for most patients.

Dr Alex Ionnidis recalled that right from the start, he was pleasantly surprised by the iStent’s safety profile. “I did about 20 G1s for patients who were all on latanoprost and apart from one, they all had a pressure drop, which was significant. And the thing that surprised me was that there were hardly any complications; it was a safe procedure. The patients were happy the next day. We switched to G2 soon after it came out, and I was sold. I said, ‘there's something here, there’s something here’”.

Dr Nathan Kerr observed the advantages of iStent infinite: “I’ve used all generations – starting with the original iStent back in 2016, the iStent inject, and now the iStent infinite. When we analysed our real-world registry data, the pattern was clear: each iteration has delivered better efficacy. The original single-stent device worked well, the two-stent inject improved on that, and the three-stent infinite provides even greater effect. It really demonstrates how the technology has been continuously refined over time.”

From the surgical perspective, Dr Howes said the improvements with each generation of the iStent had been noticeable. “The first iteration was a lot more difficult to implant – you had to manipulate your hand to get it into position”, he said. However, with the G3, “there are no complications”.

“I personally believe that the infinite has hit it out of the park.”

According to Dr Clement, three stents also provide a psychological advantage. “Having so many more chances eliminates what I call ‘range anxiety’. Like worrying about running out of charge in your electric car; if you don’t get the first stent in perfectly, you can always rethread it, and that has helped with doctors’ confidence,” he observed.

However, with each iteration comes new techniques to learn, and the surgeons agreed that taking time, identifying collector channels, and spacing stents appropriately were essential for optimal outcomes.

Dr Lawlor advised intraoperative gonioscopy. “It’s crucial. When I put in an iStent with good gonioscopy, people say ‘it’s great, I can see where the stents are going, it’s beautiful’.”

For correct placement of stents, Dr Lim said “the message needs to be clear: go slow, do each placement very precisely, take your time, make each shot perfect, space them out, turn your microscope. These are simple messages, but it’s not a fast procedure – you have to look at those stents post-operatively.”

Reinforcing the point Dr Clement said, “The practical difference between rushing it and going slow is very little. If you rush, you’re done in a minute. If you take your time, it’s only a few minutes more. But the quality difference is enormous.”

REAL-WORLD DATA AND DIFFERENTIATION

The collection of robust real-world evidence has always been a priority for Glaukos, and to this end the company collaborated to establish the Save Sight Registries’ Fight Glaucoma Blindness! registry, a world-leading, web-based platform where surgeons anonymously log and track real-world patient data for glaucoma treatments – especially MIGS devices. Acknowledging the importance of this approach, Dr Mitchell Lawlor said the data generated had “shown real rewards in terms of understanding how these devices are used across the board”.

The Registry’s data has enabled head-to-head comparisons of the safety and efficacy of different devices, with Dr Lawlor declaring that the data shows that “big is not necessarily better” and “the iStent, particularly with the infinite, has a much better safety profile”.

“I started as a sceptic. I’m naturally sceptical about most things, and that was one of the rationales for developing the evidence base through the Save Sight Registry. We didn’t have data showing it worked in real-world settings. With additional data, I’m completely on board now. The data is absolutely unequivocal, and cost-effectiveness is pretty clear too.”

And with that data has come a significant change in the way Dr Lawlor practises. “I’m advocating for very early cataract surgery with iStent in glaucoma patients. If there’s any possibility a trab (trabeculectomy) might be needed in the next couple of years, I get the cataract with iStent in early. I then have a pseudophakic patient to do a trab on if needed. For a 74-year-old patient who’s going to die at 78 without needing that trabeculectomy – that’s actually a win.”

Access to the iStent has also reduced Dr Lance Liu’s need to perform trabeculectomies. “Patients who had problems with drops, or where laser didn’t work, would previously progress straight to trabeculectomy. Now we have another option that may prolong the path towards a trab or just stabilise things for a longer period,” he observed. “For patients, not having to take another medication or use drops is one less thing they need to worry about – especially given that most of these patients are already on multiple medications for other health problems.”

Dr Kerr said MIGS had also reduced the interval between appointments. “Once patients are drop-free and stable after iStent surgery, we can extend review intervals. That’s better for the patient – less cost and burden of follow up. But it also creates more capacity, allowing more patients to be seen. Of course, it is a treatment and not a cure, and patients still need lifelong follow up, but from a health system perspective, MIGS has been really beneficial.”

With patients increasingly researching online for glaucoma management options, Dr Ku said the arrival of MIGS has generated optimism. “I notice less fear in patients. They used to come in saying, ‘I am so scared that I’m going to go blind’ or, ‘Am I going to end up losing vision like my mother?’ Now, there’s more hope in overall glaucoma management and patients are requesting the use of MIGS.”

MIGS AS STANDARD OF CARE

With all the advantages that MIGS delivers, it’s easy to understand why the doctors in the room now consider this approach as standard of care for mild to moderate glaucoma patients who are non-compliant with drops.

MIGS must now become a “core competency for any ophthalmologist performing cataract surgery in patients with glaucoma”, Dr Kerr said. “It should be seen as a fundamental skill.”

Prof Healey believes that today, there should be no one “in Australia who looks after glaucoma who doesn’t think about this technology”.

“Even if they don’t do it themselves, even if they do it occasionally, they’re thinking about it. There’s no ophthalmologist for whom it has no place. That’s what makes something standard of care – not that everyone does it all the time, but that everyone considers it as an appropriate option for the right patients.”

And with growing numbers of patients now specifically asking for iStents, Dr Cheng said surgeons must be up to speed on patient suitability.

“Early on, we could confidently answer whether it works, but not how it would work specifically for each patient. That’s what’s changed over time – we now have longitudinal experience and data that allows us to counsel patients much more accurately about expected outcomes.”

For optometrists, the surgeons agreed that standard of care means advising patients of all the options available to them: medicines, laser, and operations, including iStent and other glaucoma procedures.

However, Dr Lawlor cautioned that the decision over which procedure is best for the individual patient must be left to the ophthalmologist. Furthermore, over-promising about likely outcomes for any approach is to be avoided by all eye care professionals.

“There’s a danger in being too specific about outcomes because there’s such variety in which patients are suitable. Patients with ocular hypertension may have realistic expectations of getting off drops completely. Patients with more advanced glaucoma won’t get off all their drops, but may avoid trabeculectomy with a small pressure reduction… We can’t say to a patient that a procedure will get them off their drops. The phrasing needs to be careful – it’s an alternative treatment option, you may still need combination therapy.”

For patients with cataract and glaucoma, he said, “follow the evidence”.

“Cataract surgery with an iStent is better than cataract surgery alone in controlling glaucoma. That’s a straightforward statement that the evidence completely supports, and it allows them to make recommendations across the whole range of patients.”

PREDICTING THE FUTURE

As the evening drew to a close, the ophthalmologists shared their predictions for the future of glaucoma care. Dr Manning suggested: “I think we’re going down the path of early surgical intervention. There will still be a need for laser and medicines to tide patients over until they’re ready to make a surgical decision. But I think we’re going to operate a lot earlier.”

Dr Howes predicted that the term ‘interventional glaucoma’ will disappear. “It will just evolve into contemporary glaucoma care,” he suggested.

And Dr Ku spoke about diagnostic advancements – imaging and genetic testing – that will improve patient selection for individual treatment approaches. “That would be transformative,” she said.

Prof Healey offered a different perspective on the biggest future change: “The elephant in the room is that glaucoma is not a disease of pressure – it’s an optic neuropathy. There may come a time when we crack that puzzle and no longer need to treat pressure exclusively; that’s not in the next 10 years, but eventually. The joyful thing for glaucoma surgeons is that we won’t have to get pressure down to 6 or 7 mmHg to prevent progression, because neuroprotection will help. But we’ll still need to get pressure to between 10 and 15 – and that’s where angle surgery works beautifully.”

AN ETHICAL PARTNERSHIP

As Glenn Fawcett called the evening to a close, he reflected on the past 10 years with Glaukos. “I’m humbled by the fact that everyone has trusted Glaukos. We can always do better, and we strive to do better. I’m looking forward to the next 10 years and what we’ve got coming, but more broadly, what’s coming for patients as well.”

But it was perhaps Prof Healey’s closing words that captured the essence of the evening. “The funny position we’re in as surgeons and doctors is that we don’t work for industry, but we have to work with industry – otherwise we don’t have the tools to treat our patients. It’s as simple as that.”

Observing that the feedback loop between doctors and industry enables continuous improvement, he said, “it works well if everyone in this pathway is ethical”.

“My experience with Glaukos is that it holds strong corporate ethics. The claims it makes are supported by good data, and the improvements made to products make them better. Our patients are the beneficiaries of that. So thank you, Glaukos, for existing, for making these products that help us, and for giving us the tools we need to manage this very challenging and difficult disease.”