Until recently, the treatment for glaucoma – a group of diseases that cause pressure within the eyeball – consisted of several options, none of them ideal. Patients could opt for medicines, either oral or via eyedrops, to lower eye pressure. A surgical option that in essence creates a drain in the eyeball for ocular fluid is also available, as is a procedure call laser trabeculoplasty that also creates a drainage pathway.
But a new generation of medical devices that resemble miniature stents could change all that. Inserted via a minimally invasive procedure, the stents create a permanent drain for ocular fluid to pass from the eye and lower its intraocular pressure.
One such device is the CyPass micro-stent that’s being developed by Transcend Medical. Transcend Medical CEO Brian Walsh told MassDevice.com that Menlo Park, Calif.-based Transcend, which drummed up a $51 million Series B round in 2011, is the 1st company to spin out of the ForSight Laboratories incubator.
Although it’s not the 1st miniature stent aiming to hit the U.S. market (Glaukos won the FDA’s approval for its iStent in 2012), Walsh said the CyPass device’s intuitive and ergonomic design distinguishes it from other micro-stents.
Following is a transcript, edited for clarity, of our interview with Walsh.
MassDevice.com: What differentiates the CyPass device from other device-based glaucoma treatments?
Brian Walsh: Great question. The CyPass micro-stent is implanted in the supraciliary space, facilitating an increase in the natural fluid drainage. The device acts along the same outflow pathway as the most commonly prescribed medications, which are prostaglandin analogs. Those are the most commonly used pharmaceuticals to treat glaucoma.
Considering that most patients are on 2 or more medications, the issues with compliance and with side effects are not insignificant. However, physicians are utilizing medications to avoid conventional glaucoma surgery. There aren’t many technologies to help bridge the gap between medicines and invasive surgery. The CyPass micro-stent is more or less a minimally invasive intervention, versus an invasive surgery. Micro-stent technologies offer a minimally invasive option, only requiring topical anesthesia and a very straightforward stenting procedure to reduce the pressure in the eye.
One thing about the technology that really differentiates it is that it has a very intuitive design and is very ergonomic. Therefore, it’s straightforward to use and highly adoptable. It’s differentiated over all other micro-stents in development.
MassDevice.com: The CyPass device is used in conjunction with cataract surgery?
Brian Walsh: In the United States, our trial is randomized with cataract surgery plus the CyPass Micro-Stent versus cataract surgery alone. That was the design that the FDA was comfortable with and it was also the design of the pivotal study of the micro-stent that is currently on the market.
MassDevice.com: Is that the iStent?
Brian Walsh: Yes. Now, we’ll be following the path of the iStent relative to the clinical trial. However our clinical trial is twice as large, with more than 500 patients. It’s a very robust clinical trial and the largest of its kind that is currently enrolled.
MassDevice.com: You’ve had CE mark approval in the European Union since 2008. How many markets are you in overseas with the CyPass?
Brian Walsh: We’re in several, doing very selective commercialization. And 50% of the patients that are being treated abroad are not in conjunction with cataract surgery.
MassDevice.com: Can you give us an update on where you are in the path to approval in the U.S., and your clinical trial?
Brian Walsh: Yes. Our clinical trial actually is a pivotal [pre-market approval] trial, not a 510(k). I’m really happy to explain this to you because I think the differentiation is significant. There is a 510(k) path for an implantable device to treat glaucoma, but that pathway will only give the technology an indication for end-stage glaucoma; for glaucoma that has failed a previous incisional surgery. That market, we believe, is very small. You have to wait for glaucoma to progress so far that patients need multiple medications, and finally they get invasive surgery. Ultimately, invasive surgery fails and then that’s your indication for use; that’s not a very attractive opportunity for us.
We have a technology that we believe can be introduced much earlier in the treatment paradigm, after maybe 1 or 2 failed medications. As a result of that, we took a path to do a PMA, not a 510(k). The PMA is about 10 times larger than what a 510(k) would entail, as far as numbers of patients treated. Also, the follow-up period is 2 years versus 1 year.
MassDevice.com: You just closed a $22 million Series C round that included a strategic investor. What’s the total investment so far from all your rounds in Transcend?
Brian Walsh: Roughly $80 million. The significant [Series C] raise as well as the participation of a global pharmaceutical and medical device corporate partner, I think really helps validate what we’re doing. Validation of the space, validation of our technology.