Glaukos - Tomas Navratil, Chief Development Officer

Good morning, and I'd like to thank Bill, Amit, and Craig for the invitation to speak, and I'd like to thank the audience for the opportunity to present an exciting update on the Glaukos R&D strategy, three recent medical device approvals, as well as two sets of positive Phase 3 results, all having occurred in the near-term past at Glaukos. So these are our forward-looking statements. As you know, Glaukos was initially created with the intent on transforming glaucoma therapy, and innovation is truly at the heart of everything that we do at Glaukos. This effort led to the creation of a new medical device class, the trabecular bypass devices, with the first-in-class product iStent and ultimately the Glaukos marketplace. The iStent product, together with our first-in-class keratoconus treatment, are the cornerstones of our commercial franchises. But as you know, our aspirations are much higher than that, and so this focused effort led to the creation of an exciting near-term pipeline with another transformational product, Idose, in a pre-NDA stage, a fully loaded mid-stage pipeline, and a truly deliberate focus on growing the global organization to prepare for future growth. The R&D strategy for future growth and value creation is really based on utilizing these technological platforms, each of which alone has the potential of spawning multiple paradigm-shifting products that are then able to be leveraged in our scalable commercial platform. The key thought that I'd like to leave you with today is something that has been truly practiced at Glaukos since its inception, and that is literally to challenge and change the chronic paradigm of topical eye drops. As we highlighted yesterday in many presentations, there are many shortcomings, and that is what we are addressing at Glaukos. So utilizing this principle of dropless therapy, we are deliberately seeking to radically change the way we treat ophthalmic diseases, leveraging these five medical device and pharmaceutical-based ophthalmic platforms targeting glaucoma, cornea, and retina. Beyond our iStent trabecular bypass platform, the Idose is a miniature implant implanted in the anterior segment of the eye and capable of eluting multiple years of pharmacotherapy into the anterior segment. The iLink platform is based on UV light-activated biopharmaceuticals and is embodied by our keratoconus treatment. The iLution platform is a dropless transdermal therapy that delivers potent pharmaceuticals to the anterior segment and ocular surface. And the Retina XR platform utilizes the concept of biodegradable implants to treat chronic retinal diseases. The products from these five platforms are then easily plugged into our scalable commercial platform and organization that now encompasses more than 260 professionals globally, distributed across 17 markets across the globe. So let us focus on the iStent platform first, as it truly embodies the principle of spawning multiple products, starting with the original iStent, leading to iStent inject, iStent inject W, and now iStent infinite, which could be our best product yet based on this platform. I would like to highlight the strength of the iStent infinite pivotal results based on this clinical trial that supported the 510(k) clearance of this first standalone administration of a MIGS device. In this trial, we had patients who came in with fairly high pharmacotherapy, averaging three IOP medications at baseline, and also having already failed two prior incisional surgeries. Despite this best disease background, we were able to still demonstrate a 6 mmHg change from baseline in a high percentage of responders, leading to this first standalone 510(k) clearance of a trabecular bypass device. These iStent products are very nicely complemented by the iAccess goniotomy device, also cleared within the last 12 months, as well as the iPrimus phaco delivery system. The second platform I'd like to highlight today is the Idose platform, and the Idose platform comprises a miniature implant that is anchored at the iridocorneal angle and is capable of eluting multiple years of therapy into the anterior segment, starting with glaucoma. So our first-generation product, Idose TR (travoprost), is currently in a pre-NDA stage. Our second-generation product, Idose TRX (travoprost extended), contains twice the payload and twice the duration of our first-generation product. And our Idose T-Rock (rock) delivers a potent rho-kinase inhibitor, the IOP-lowering effects of which are fully complementary to the Idose TR IOP-lowering effect. Let me highlight two exciting sets of Phase 3 results that we have recently disclosed, demonstrating that Idose primary efficacy fully supports the NDA application, demonstrating a range of IOP-lowering results of 6.6 to 8.5 mmHg as a change from baseline. Please note that in these two large, well-controlled studies studying over 1,100 patients, more than a quarter of the patients came in on more than two IOP-lowering medications at baseline. Despite this robust pharmacotherapy at baseline, at 12 months we were still able to demonstrate that 93% of patients were well controlled at 12 months after a single dose on the same or lower number of topical IOP-lowering medications, and 81% of all patients were completely IOP-lowering medication free. Importantly, the safety and tolerability in this trial was excellent, demonstrating no serious corneal adverse events, no adverse events of periorbital fat atrophy, and industry-best-in-class 3% hyperemia rate, which is more than tenfold lower than topical hyperemia due to topical travatan Z. Importantly, a number of sites administered Idose as an office procedure. So these 12-month results from two completed Phase 3 studies very nicely build on the completed three-year outcome of our completed Phase 2b program, where we demonstrated that three years after a single dose, 70% of patients were still controlled on the same or lesser number of topical IOP-lowering medications. So in summary, zooming out back to the platform level, these five Glaukos therapeutic platforms are truly capable of generating waves of novel, paradigm-shifting therapies targeting not only glaucoma but also dry eye disease, presbyopia, keratoconus, AMD, DME, RVO, and a host of other orphan ophthalmic diseases. I would be truly remiss not to recognize the incredible number of patients and clinicians who supported this progress, some of whom are sitting here in the room. Thank you so much for being such incredible partners in this endeavor. Without you, this progress and this Promethean innovation would not be possible. So in summary, we believe that Glaukos is different, as we are truly delivering multiple disruptive dropless therapies to patients in need. And so, given the recent success and approvals of iStent infinite, iPrimus, iAccess, combined with the two positive sets of studies in Phase 3 supporting Idose NDA submission, we have a high degree of forward momentum as we deliver and execute on our R&D strategy, preparing for future growth. Thank you so much.