Two companies developing tiny stents used to relieve pressure in the eyes have completed venture funding rounds in the last week. In one case, the cash will be put towards a clinical trial – but in the other, the money raised is likely to fund worldwide launch of the smallest device the FDA has ever approved.
Glaukos’s iStent, approved in the US last June, is minute – 1mm in length with a bore diameter of 120 micrometres. Glaukos has raised $30m in a series E round and is cagey about its plans for the cash, though launch would be the obvious path. Ivantis will use its $27m series B round to complete a head-to-head trial of its product, a slightly larger, crescent-shaped tube called the Hydrus Microstent, versus the iStent.
Premarket approval (PMA) was granted to Glaukos’s L-shaped titanium implant for use in conjunction with cataract surgery to reduce intraocular pressure in adults with glaucoma. Approval was based on a 239-patient trial, plus safety data from a further 50 participants, which showed that a year after surgery, 68% of participants given the iStent had the study’s target eye pressure. compared with 50% of those who underwent cataract surgery alone.
This may not seem a huge advance, but as well as persuading the FDA of the device’s merit Glaukos has convinced investors including OrbiMed, InterWest and Meritech that the iStent’s future is worth their while.
Likewise, Ivantis completed the first tranche of its $27m round, which remains open for additional investors, on Friday. The round was led by a new investor, Ascension Health Ventures, with other backers including Delphi Ventures, New Enterprise Associates and MemorialCare Innovation Fund, and will support four trials of Hydrus MicroStent.
Of these, the Hydrus III study assessing the Hydrus Microstent against the iStent – the first head-to-head trial of these technologies to be conducted – is the most important. The study design suggests that Ivantis is hoping to get the device cleared via the 510(k) pathway using iStent as the predicate, but the technology is so new it is possible that the FDA will not permit this, forcing Ivantis to go through the lengthier and more expensive PMA route.
The device is already CE marked and on sale in Europe, as is the iStent. Outside the US, the Hydrus MicroStent is being used both in cataract and in standalone glaucoma surgery, Ivantis said.
Both companies are certain that the devices address an unmet need, with Ivantis contending that glaucoma medication costs nearly $3bn per year in the US, with dubious levels of effectiveness and patient compliance.
Two one-product companies using very similar, innovative technology to attract big investors might not be a trend exactly, but it definitely signals a new area to watch. The future of the companies will be worth keeping an eye on too: both could be takeover targets. Any prospective acquirers will be watching the results of Ivantis’s trial to see which stent, and which company, is the winner.