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Innovation leads to development of MIGS space
Creating a new therapeutic category benefits patients, surgeons and manufacturers.
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Historically, glaucoma surgical therapies have been aimed at late-stage, challenging cases that have not responded to other therapies along the way. With the evolution and development of the microinvasive glaucoma surgery space, we now have surgical interventions for earlier stages that are elegant and have low morbidity. These surgical solutions complement other therapies for glaucoma and allow us to enter a new era in which surgical glaucoma therapy at all stages can be lower risk while reducing or even eliminating the patient’s dependence on medications.
Getting to market
As a game-changer in the field of glaucoma therapy, MIGS devices are going to extensive lengths to prove their worth. The iStent Trabecular Micro Bypass (Glaukos) was the first MIGS device to receive U.S. Food and Drug Administration approval, and as a first-in-class device, it went through a complicated and challenging premarket approval (PMA) process. The PMA process is more complex and time-consuming than the 510(k) premarket notification process. The PMA path requires clinical trials that are larger and more rigorous than those required for the 510(k). To provide a solid scientific and clinical foundation for the MIGS category, Glaukos has committed to and is currently conducting numerous additional clinical trials beyond those required for FDA approval.
William Link
Due to the substantial prevalence of glaucoma in patients with cataracts, it makes sense that the initial development of the MIGS space has been in conjunction with cataract surgery. Combining these procedures helped Glaukos and the FDA gain confidence in the iStent procedure because it was not being performed on a naïve eye, but rather an eye that was already undergoing surgery.
Any leader in a new space has an important responsibility to do things well, and I feel Glaukos has risen to the challenge. In addition to making sure that the first MIGS devices have a solid scientific and clinical foundation, the company is dedicated to providing education, training and reimbursement support to the surgeons and their respective institutions. Given that it took longer than the company expected to get FDA approval for the U.S. market, Glaukos used the time wisely to organize and provide the basis for appropriate reimbursement of the iStent. This was achieved sooner than most new medical technologies, and I believe that is recognition of the forward thinking of the Glaukos team.
Initial success
The year 2013 was the first full calendar year of having the iStent available in the U.S., and it gained a lot of support and enthusiasm from surgeons and patients. Any time you innovate and disrupt a market, there will be skeptics. It is a healthy process that requires the innovators to do their job well and provide real value and merit. Based on the FDA trial as well as multiple other well-designed clinical trials, it is clear that one stent provides meaningful, sustained reduction of IOP. We are also seeing evidence in additional trials that the IOP reduction is increased with two stents. Over time as we see these data published, we will likely see some movement in the market to multiple stents vs. a single stent.
The future of MIGS
I believe that in the next half-decade, we will see MIGS therapies being used more frequently in phakic and pseudophakic patients as well as during cataract surgery. I also expect the path to FDA approval for future devices in the MIGS category to be more predictable and possibly more efficient than with the iStent. Another change I see to the MIGS category is the titratability of therapy. The first-generation iStent, which I am most familiar with, is showing great success. The second-generation device, iStent inject, is an injectable that allows two stents to be implanted simultaneously, either during cataract surgery or in the phakic eye. Glaukos is also developing a third-generation implant that works in the suprachoroidal space to tap an additional outflow channel.
In addition to the work being done by Glaukos, several other high-quality companies are innovating in the MIGS space. I have seen projections that anticipate a billion dollars of revenue in this category in the next decade. That equates to hundreds of thousands of patients, as well as surgeons and manufacturers, benefiting from advanced glaucoma technologies.
Now that we are firmly in the era of MIGS therapies, we must stay open-minded about other benefits that can be delivered to the patient. One area of priority for Glaukos is to investigate ways to reduce pressure by simultaneously improving outflow and delivering medication. Furthering MIGS technology to create a device that functions in both of those capacities could be on the horizon. Glaukos and the other companies in this space have a firm commitment to changing the glaucoma treatment paradigm, in ways that are both innovative and scientifically backed. It is an exciting time for ophthalmologists and patients alike.