Ophthalmology is the next frontier for stent technology. Micro-invasive glaucoma surgery (MIGS) will only be the first wave of stent technology, said Sean Ianchulev, MD, MPH, chief medical officer of Transcend, which was bought by Alcon earlier this year. It’s only logical that a disease reliant upon fluidics and outflow will be the one to incorporate the technology.
“The current companies in this space are riding the wave, but they must be thinking about 10 years from now,” Dr. Ianchulev said. Before 2000, trabs and tubes were the only interventional surgery available to treat glaucoma; over the last few years, he explained, “we’ve seen a huge expansion over those technologies” to include several MIGS devices and safer techniques to perform trabeculectomy, and many more are on the horizon.
“This transformative innovation has been enabled by clarity of the regulatory process, strong clinical and regulatory science, and a development framework,” Dr. Ianchulev said. “More so today than 20 years ago, we have to subscribe to level 1 clinical evidence and work through the regulatory process to get those technologies to the patient.”
A small series of 20 or so patients or a case series with a registry in Europe is no longer adequate. The first MIGS PMA study started in 2005, was completed in 2010, and was approved in 2015. Transcend began development on the CyPass microstent technology in 2009 and obtained approval last year
“No matter how many resources you throw at it, it takes about six to seven years to complete a clinical trial,” Dr. Ianchulev said. “It’s a very involved process” with a much more predictable time line. The first MIGS study enrolled 240 patients; the first CyPass PMA study enrolled 505 and remains the largest MIGS PMA study to date.
“This is the new reality for validation,” he stated. Endpoints have evolved from 12 to 24 months, safety follow-up studies now run 24 months, and terminal washout of topical meds is now required, as are pre-set diurnal pressure measurement evaluations.
“It used to be a 510(k) world for glaucoma devices, but that is changing, particularly if companies are developing technologies for the non-refractive population,” Dr. Ianchulev said.
Sean Ianchulev, MD, MPH
Dr. Ianchulev is a physician-executive, innovator and venture capital investor with deep life-science and medical technology expertise. As an innovator he has been at the core of medical products and technologies which have transformed the ophthalmic practice.