Glaucoma is the leading cause of irreversible blindness, affecting around 100 million people worldwide. Good news though: the innovative implant MINIject – developed by Wavre-based company iSTAR Medical – has the capacity to prevent progression of the eye disease. The first commercial MINIject implantations are currently being done in Germany, with other European countries to follow soon and a trial in the US underway.
This article was authored by Andy Furniere.
Glaucoma is the result of damage to the optic nerve in the eye. As this nerve gradually deteriorates, blind spots develop in the visual field of patients. “This damage to the optic nerve is caused by high pressure in the eye,” explains Michel Vanbrabant, CEO of iSTAR Medical. “The pressure builds up because a crucial fluid called aqueous humour, which nourishes the tissue in the eye, cannot be drained out from the eye as it should. This occurs because the exit channels are blocked, for reasons yet unknown. If the disease is not treated, 1 out of 5 people with glaucoma become blind within about 10 years.”
There currently is no cure for glaucoma yet. With eye drops, the pressure in the eye can be controlled, but this is far from an ideal solution. “About half of the patients don’t take their drops as often as they should, which often is 3 or 4 times a day, and many patients don’t administer them correctly. The drops can also cause side effects, such as dry and red eyes.” The traditional surgical techniques are far from perfect as well. “With laser therapy, you can restore the drainage of the aqueous humour fluid, but the effect lasts only 2 to 3 years.”
An implant that becomes a part of your eye
In the last 15 years, minimally invasive glaucoma surgery (MIGS) implants have become the most promising and fastest-growing glaucoma therapies. “You can implant these small devices in the eye in about 5 minutes’ time,” says Vanbrabant. “However, until recently, the implants couldn’t offer a combination of efficiency and safety, which is where we come in with our MINIject.”
“If the disease is not treated, 1 out of 5 people with glaucoma become blind within about 10 years.” – Michel Vanbrabant
The MINIject specially targets open-angle glaucoma, the most common form of glaucoma. The basis of the MINIject is the STAR material, to which the Belgian company’s name refers. It was originally developed by researchers across the Atlantic, in the labs of the University of Washington, in the American city Seattle. The unique material is made of soft and flexible, medical-grade silicone which conforms to the eye anatomy. Its structure is composed of an organized network of hollow spheres which has a positive impact on drainage in the eye.
“Contrary to other MIGS, often made of metal and plastic, the MINIject is because of the STAR material not rejected by the eye tissue. On the contrary, it is perceived as a ‘friendly’, so that the tissue will partly grow over the device, a process called biocolonisation.” The device itself looks like a little, flexible tube, which improves the drainage of the fluid in the eye and keeps the eye pressure stable. The place where it is inserted is important as well: unlike any other MIGS devices commercially available, the MINIject can be implanted into the supraciliary space in the eye, a natural fluid-drainage pathway for powerful reduction of eye pressure.
A safe and powerful solution
iSTAR has followed the performance of the MINIject for three years in 150 patients, with very positive results. “The implant is proving to be safe and very powerful,” says Vanbrabant. “It can reduce the eye pressure with about 35 to 40%, which is very important to stop the progression of the disease. It also reduces the necessary amount of eye drops by half. 40% of the patients with a MINIject don’t even have to administer any eye drops anymore.”
“The implant is proving to be safe and very powerful. It can reduce the eye pressure with about 35 to 40%, which is very important to stop the progression of the disease.” – Michel Vanbrabant
At the end of last year, the first commercial implants were done in Germany. The next target markets for iSTAR are Austria, Switzerland, and the UK – countries in which the MIGS implant can be reimbursed. “Belgium’s reimbursement system is less favorable for us, but we still want to introduce it here soon as well, since we are a Belgian company. It should come on the market in Belgium next year.”
The company also received approval by the Food and Drug Administration (FDA) in the US to start up a 350-patient trial called STAR-V, a crucial step towards introduction on the American market. “We should have the data of this trial by 2025, so that we hopefully can bring it on the market there in 2026.”
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Since its foundation in 2011, iSTAR has raised €55 million among investors such as the Berlin-based venture capital firm Earlybird, the Belgium-based investment firm Capricorn Partners and the Regional Investment Company of Wallonia (SRIW). Late last year, the company also secured a €20 million quasi-equity financing agreement with the European Investment Bank (EIB).
Apart from its solution to glaucoma, iSTAR is also looking to develop implants against other eye diseases. “We are currently collaborating with two leading universities in Europe to design other applications,” says Vanbrabant. “More news about that to follow in the second half of this year.”
