Istar Flies Towards Next-Gen Glaucoma Surgery Device

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Includes: AGN, GKOS, NVS
by: EP Vantage

Some might feel that the Belgian minimally invasive glaucoma surgery (MIGS) device developer Istar Medical has missed the boat, with three of its rivals already acquired (see table below). But its chief executive, Michel Vanbrabant, is unperturbed.

“We are behind, it’s true,” he tells EP Vantage. “But I think we bring to the equation a next-generation MIGS solution, which will raise the bar significantly over current-generation MIGS in terms of response rate.”

This improved performance, he says, is enabled by the material used in Istar’s device, which was originally developed by the University of Washington in Seattle before being licensed to the company. “It exhibits very different properties to traditional implants when inserted into the human body.”

Better drainage?

Increased pressure in the eye can damage the optic nerve and lead to glaucoma. MIGS products aim to reduce this by allowing excess intraocular liquid, called aqueous humour, to drain away.

However, current devices – including the two that are FDA-approved, Glaukos’s (NYSE:GKOS) iStent and Novartis (NYSE:NVS)/Alcon’s CyPass Micro-Stent - lead to fibrosis in 20-25% of patients because “all of them use hard material that triggers some fibrotic responses in the eye,” Mr. Vanbrabant says.

Istar's material is softer and more flexible, so is not associated with this issue, according to the company. The faster speed of drainage through a single stent or tube could also contribute to scarring with the first-generation devices, the chief executive adds.

While Istar's technology acts like a shunt, “it is not a tube or stent but provides thousands of small conduits for aqueous humour to flow through,” Mr. Vanbrabant says, which is more like the fluid drainage seen in healthy tissue.

The implant also integrates with the patient’s own tissue “to support drainage without blockage,” he adds. All of these properties “reduce the incidence of fibrosis, minimize scarring, and increase implant performance over time."

This company believes that this should allow the product to capture market share from existing devices once it reaches the market.

It still has some way to go. So far, the company has been focused on its CE-marked STARflo device, but this will shift in the near future to its newer product, MINIject. STARflo has been used to prove the concept, but is not suitable for wide commercialization because it needs to be implanted by specialized surgeons using traditional surgical techniques.

MINIject shift

MINIject is the commercial product. It comes on a premounted delivery system, making it easier to implant as well as less invasive, and can be delivered by cataract surgeons as well as glaucoma surgeons, increasing the user base, Mr. Vanbrabant says.

STARflo is in a multicenter European trial due to report results in the first half of 2017 - if successful, it will pave the way for the more user-friendly MINIject, which is set to start its first human trial by the end of this year. European trial data on MINIject should be available in 2018, at which point iSTAR plans to apply to the FDA for permission to start a US study.

The group raised a €10m ($11m) series B in April and has enough cash to take it to CE marking MINIject, at which point it will need more funds to commercialize the product in Europe, as well as to carry out the US trial.

Istar might opt to sell the device itself in the EU, though a US partnership could be on the cards. But a trade sale seems to be what the company is working towards.

Companies with approved MIGS devices

Originator

Acquirer

Device

EU status

US status

Glaukos

-

iStent

CE marked 2004

PMA granted June 2012

Transcend Medical

Novartis/Alcon

CyPass Micro-Stent

CE marked 2009

PMA approval granted July 2016

Aquesys

Allergan

Xen45

CE marked

Filed; 510(k) clearance expected late 2016

Ivantis

-

Hydrus Microstent

CE marked June 2011

Not yet filed

Innfocus

Santen

MicroShunt

CE marked January 2012

Not yet filed

Istar

-

STARflo/MINIject

CE marked July 2012

Not yet filed

Click to enlarge
Click to enlarge

Istar is already in touch with potential partners; Mr. Vanbrabant says: “I don’t think there’s more than one major player that we’re not in contact with.” This includes the companies that have already made acquisitions, which “need to improve the technology that they either just acquired or plan to acquire.”

As for smaller companies, there are several of these behind Istar in terms of development. These have produced “concepts that are very different from our biomaterial – but nothing I was convinced of,” the chief exec says.

“So there is high competition, but the competition is first and foremost coming from Glaukos, Alcon and Allergan (NYSE:AGN) – who will more likely be creating the market for MIGS as opposed to being a competitor to us when we hit the road two or three years from now.”

The MIGS sector is likely to stay hot with an aging population and issues with glaucoma drugs, including low compliance. If it does, and Istar proves that its product has an edge over existing devices, it could soon see interest from the big players.

This story has been changed to reflect the fact that the CyPass Micro-Stent received PMA approval.