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Glaukos CEO reviews FDA approval of iStent
Intended use of the device is to reduce IOP in mild to moderate open-angle glaucoma in tandem with cataract surgery.
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The U.S. Food and Drug Administration recently approved the iStent Trabecular Micro-Bypass stent system from Glaukos for use with cataract surgery to reduce IOP in adults with mild to moderate open-angle glaucoma currently being treated with ocular hypotensive medication. The 1-mm device is designed to be placed ab interno into Schlemm’s canal using an inserter and intraoperative gonioscopy.
Ocular Surgery News spoke with Glaukos CEO Tom Burns about the approval.
Ocular Surgery News: What does the FDA approval of the iStent mean for Glaukos?
Tom Burns: FDA approval represents the culmination of a decade of intensive research and development, thoughtful innovation, and extensive clinical studies to validate our technology.
Tom Burns
Our vision from the company’s founding in 2001 has been to develop compelling technology and bring this emerging micro-invasive glaucoma surgery (MIGS) market class to the ophthalmic community to provide surgical options to advance the standard of care for open-angle glaucoma. iStent is the flagship product of the emerging MIGS market class. We are now delighted to be able to provide this new technology to comorbid cataract and glaucoma patients in the United States who may benefit from its use.
OSN: Could you discuss the development of the company and the iStent itself?
Burns: Glaukos has strived to become the foundational leader of the emerging MIGS category. The company has paved the commercial and regulatory landscape for MIGS, dedicated more than a decade of research and development of the MIGS technology, and raised $126 million of private equity to date to build this market class.
We formed the company in January 2001 to create a portfolio of micro-scale devices that would ultimately provide clinical value to the full range of open-angle glaucoma patients. We have developed two generations of trabecular bypass devices and a suprachoroidal device to improve aqueous outflow through these important physiologic pathways.
iStent is the first MIGS device that we are currently commercializing. The second generation, iStent inject, is a preloaded device in an expanded phase premarket approval (PMA) registration study that implants two trabecular devices with a single entry into the anterior chamber. The iStent supra provides a bypass of the ciliary muscle attachment to allow aqueous to flow into the suprachoroidal space. We also have secured an open investigational device exemption and have begun our FDA registration study for this device.
The company has already conducted extensive groundwork to aid in reimbursement for the procedure and the device during the U.S. commercial launch. We secured two Category III Current Procedural Terminology (CPT) codes: 0191T for the reimbursement of the trabecular bypass devices and 0253T for the reimbursement of suprachoroidal devices, which will allow Medicare contractors and other third-party payers to assign physician payment levels for these new procedures. The Centers for Medicare and Medicaid Services has assigned these CPT codes to APC 673, which will provide adequate payment to the facility for the cost of the procedure and the iStent.
OSN: Are there lessons that you learned during the first approval that you are implementing with getting the second- and third-generation devices approved?
Burns: We were the first ophthalmic company to conduct a randomized, comparative control PMA study in glaucoma to validate the safety and efficacy of the iStent device. We believed that additional clinical rigor of this level 1 study would better establish the clinical credibility of the technology, aid in reimbursement and accelerate the rate of adoption upon commercial launch. With any newly chartered regulatory pathway comes associated risk. In our case, risk was ultimately rewarded. This new regulatory pathway, confirmed by our recent FDA approval, has become the template for other companies who have chosen to follow us into this market.
OSN: The approval was for use with cataract removal only. Why have it approved with cataract surgery?
Burns: Comprehensive ophthalmologists have increasingly used cataract surgery as a platform to treat a variety of visual disorders (eg, astigmatism, presbyopia). Treating open-angle glaucoma in combined cataract procedures is a next logical step in utilizing this expansive platform. We developed iStent to be implanted through the existing cataract incision in a combined procedure to expand the cataract surgery platform and to create a favorable benefit-to-risk ratio for patient candidates. In doing so, iStent is the first FDA-approved device to treat non-refractory glaucoma patients at a far earlier stage of disease morbidity (mild to moderate open-angle glaucoma).
The comorbidity rate between medicated open-angle glaucoma/ocular hypertensive patients undergoing cataract surgery in the United States is approximately 20%. We are therefore addressing several hundred thousand patient candidates in the United States who may benefit from iStent implantation. This potential patient market is vastly larger than the entire volume of glaucoma surgical market procedures performed in the United States today.
OSN: Do you see this as really mitigating the need for more invasive glaucoma surgeries?
Burns: Trabeculectomy and aqueous shunts will continue to justifiably serve an important and continuing clinical role in treating refractory open-angle glaucoma even after the introduction of newer MIGS devices.
I do believe that the iStent provides surgeons an important option to utilize a safe, effective and blebless procedure before resorting to surgical procedures with demonstrated risks of clinical sequelae. The ab interno iStent implantation procedure is conjunctival-sparing and thus continues to preserve the options of the glaucoma surgeon to perform guarded filtration surgery and shunt implantations in end-stage disease.
OSN: Have you officially launched the product, or is that upcoming?
Burns: The company is rolling out the device by conducting a very methodical, controlled clinical launch with a select group of glaucoma specialists and comprehensive cataract surgeons.
We will be conducting a prudent 3- to 6-month controlled launch with a full surgical training program to optimize initial clinical outcomes and to establish reimbursement and distribution channels before we begin promotion to a more widespread clinical audience. To do so, we have hired and fully trained a seasoned direct sales force that is currently engaged in surgical training of our customers.
OSN: What else do you think that ophthalmologists would want to know?
Burns: Our company is focused on the scientific and clinical validation of MIGS procedures. We worked with a scientific advisory board of preeminent glaucoma specialists and glaucoma specialist consultants who have provided counsel at every stage of our development. Glaukos is currently conducting 18 prospective clinical studies, including several phase 4 clinical trials outside of the U.S. that evaluate the safety and efficacy of multiple stents in phakic and pseudophakic open-angle glaucoma patients with severities ranging from mild to refractory disease. The company has implanted more than 4,000 patients to date in prospective clinical trials. In addition, we have conducted in vitro perfusion studies of single and multiple stents at the Mayo Clinic and at the University of Colorado. We have also published novel fluid mechanics theoretical algorithms on trabecular bypass devices. The company already has 24 peer-review publications in this new MIGS space to its credit and anticipates publication of several other studies over the next several months.
OSN: Do you think that the model of the venture-backed small company is the way forward in ophthalmology or even in medical devices?
Burns: I believe that the path for innovation going forward in ophthalmology will be paved by the efforts of spirited, capable, resilient and entrepreneurial companies. These companies will, and indeed have, forge novel and compelling new technologies that will advance the standard of care across a range of ophthalmic disciplines. Larger companies may view these efforts as a form of off-balance sheet research and development financing and can capitalize on technological innovation after product development, regulatory and clinical risks have been significantly reduced or eliminated altogether.