San Clemente, Calif.-based Glaukos Corp. has finished enrolling patients in its U.S. investigational device exemption (IDE) trial for the Istent Infinite trabecular micro-bypass system, which is intended for standalone use in lowering intraocular pressure (IOP) in refractory glaucoma patients. If all goes as planned, the company is looking to commercially launch the treatment in the U.S. in 2021.
The Istent Infinite is similar to the Istent Inject, which was approved in June 2018 for glaucoma patients undergoing cataract surgery, but includes three stents vs. Inject's two. Each of the 0.36 mm x 0.36 mm heparin-coated titanium stents is preloaded into an autoinjection system, enabling the surgeon to inject them over several hours around the eye's drainage canal. Once in place, the stents help to regulate the outflow of fluid, reducing pressure in the eye. The company's initial Istent device received FDA approval in 2012.
The prospective, unmasked, multicenter, single-arm Istent Infinite study implanted 72 refractory patients at 15 clinical sites. All of the patients had previously undergone unsuccessful glaucoma surgery and were on medications that did not adequately control their IOP, some at maximally tolerated levels. The primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months postoperative with the same or fewer medications. Glaukos intends to use the results to support its bid for FDA clearance via a 510(k) submission.
"We expeditiously achieved this enrollment milestone due, in part, to the favorable safety profile surgeons experienced with their initial Istent infinite subjects, which helped to speed enrollment overall," said Thomas Burns, president and CEO of Glaukos. "We look forward to working cooperatively with the FDA as the trial process moves forward, and we continue to target U.S. commercialization of the Istent infinite, if approved, by 2021."
Glaukos has a full pipeline of glaucoma pharmaceutical and surgical products. The company's Idose Travopost intraocular implant is in phase III testing, with FDA approval targeted for late 2021 to 2022. During an Aug. 7 earnings call, Burns said the company is collaborating with D.Western Therapeutics Institute Inc. on a potential Rho kinase (ROCK) inhibitor to further leverage the Idose platform.
On the surgical side, Glaukos has completed a pivotal study of Istent Supra and will be evaluating the results to determine an FDA regulatory pathway for the device. The company is also gearing up for the U.S. launch of Santen Pharmaceutical's Microshunt ab externo surgical implant device for late-stage glaucoma management, pending FDA approval in 2020. Glaukos inked an exclusive, multiyear agreement with Santen in April to be the sole distributor of Microshunt in the U.S.
"We are poised to deliver a truly comprehensive portfolio of micro-invasive surgical devices and sustained pharmaceutical therapies, capable of providing an optimized treatment solution at each stage of glaucoma disease state severity, from the earliest manifestation to the most severe and of all [combo] cataract and standalone procedures," Burns said on the call. "We believe our glaucoma pipeline platforms, if approved, will create a sevenfold increase in our U.S. opportunity, expanding our reach to over 4 million eyes during the next several years."
In a Thursday research note, Wells Fargo's Larry Biegelsen called Istent Infinite a "sleeper" and projected that it would reap revenues of $5 million, $14 million and $27 million in 2021-2023, assuming there are no regulatory bumps along the way.
"We continue to believe that Infinite represents an under-appreciated opportunity for GKOS because (a) the approval pathway is via the 510(k) pathway which tends to be faster than the PMA pathway; (b) the company or glaucoma specialists could study the device in less severe glaucoma patients over time which would expand the market opportunity; and (c) the standalone opportunity is larger than the cataract market opportunity," Biegelsen wrote. "If Infinite is approved, GKOS could potentially have two standalone glaucoma devices, Infinite and the Microshunt, in 2021."
Along with an active pipeline, Glaukos has been building out its ophthalmic offering via recent acquisitions. In June, the company reported that it has completed the acquisition of Dose Medical Corp., which is developing micro-invasive, bioerodible, sustained-release drug delivery platforms for the treatment of various retinal diseases. The deal brought Dose Medical back into the Glaukos fold, after the previously wholly owned subsidiary was spun out in 2010.
Then in August, Glaukos snapped up Avedro Inc., an ophthalmic pharma and medical device company based in Waltham, Mass., in an all-stock transaction valued at $500 million. At the time, Burns cited Avedro's "disruptive bio-active pharmaceutical solutions and R&D capabilities" and strong reimbursement track record as assets it will bring to the merger. The deal, which is subject to Avedro shareholder and regulatory approvals, is expected to close during the fourth quarter of 2019. (See BioWorld MedTech, Aug. 9, 2019.)
For the second quarter of 2019, Glaukos saw net sales of $58.6 million, up 36% year-over-year from the same period the prior year. Based on those results, the company upped its full-year guidance to $226 million to $231 million, from $225 million to $230 million previously.