Glaukos Corp. reported 12-month results from the pivotal IDE trial of its Istent Infinite trabecular micro-bypass system, showing substantial reduction in mean diurnal intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medication. The company is targeting U.S. FDA approval of the device for standalone moderate-to-severe glaucoma in late 2021.

San Clemente, Calif.-based Glaukos has spearheaded micro-invasive glaucoma surgery (MIGS), which entails inserting a micro-scale device from within the eye’s anterior chamber through a small incision in the cornea. The Istent Infinite – the three-stent, wide-flange version of the Istent Inject – consists of three heparin-coated titanium stents preloaded into an auto-injection unit that enables surgeons to inject stents over six hours around the Schlemm’s canal, the main drainage channel for the eye. Once situated, the stents ease IOP by restoring the healthy outflow of aqueous humor, the clear liquid between the cornea and the lens.

IDE trial

The prospective, unmasked, multicenter, single-arm study enrolled patients who had undergone prior incisional or cilioablative glaucoma surgery and had either IOP that was not adequately controlled with IOP-lowering medications or were on maximally tolerated IOP-lowering medications with uncontrolled IOP. A total of 72 patients received Istent Infinite at 15 sites.

At the start of the study, patients had a mean baseline IOP of 23.4 mmHg and averaged 3.1 medications and two failed surgeries. At 12 months, 76% achieved 20% or greater reduction in mean IOP and over 50% saw IOP declines of 30% or more. Patients also showed a 13% mean reduction in medication burden at 12 months.

On the safety endpoints, the device also performed well, with no explants, infections or device-related interventions or hypotony at 12 months.

Thomas Burns, Glaukos’ president and CEO, expressed enthusiasm about the results. “These data further underscore our view that Istent Infinite may provide ophthalmic surgeons with a compelling new treatment alternative in a standalone procedure for patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy.”

During a Wednesday presentation at the J.P. Morgan Healthcare Conference, Burns called the Istent Infinite a “truly compelling” new prospect for glaucoma patients.

“I do believe surgeons will use this algorithmically, use this product in progressive patients and patients who have advanced disease before they turn to late-stage filtration procedures.”

The results compare favorably with Allergan Inc.’s Xen gel stent, according to Wells Fargo analyst Larry Biegelsen. “In our view, these results are quite competitive with Allergan’s XEN study (n=65), which had a mean baseline IOP of 23.4 mmHG on an average of 3.5 meds and showed 71%-76% mean IOP reductions,” he wrote. “We estimate XEN revenue is $40 million and Infinite is likely a safer product.”

Idose TR

Glaukos also released top-line, 24-month data from an ongoing three-year phase IIb study of its Idose TR sustained-release travoprost implant for treatment of glaucoma. Administered via a micro-invasive procedure, Idose TR is intended to continuously release therapeutic levels of a novel formulation of travoprost, a prostaglandin analog to lower IOP, for at least 12 months – providing an alternative to daily eye drops. When the travoprost is depleted, the Idose TR is removed and a new one is implanted.

The 154-patient, multicenter, randomized, double-blind IND study is assessing the safety and effectiveness of a single administration of one of two Idose TR models with different travoprost release rates vs twice daily topical timolol ophthalmic solution.

According to the results, average IOP declined by 7.9 mmHg (29%) and 7.4 mmHG (28%) in the fast- and slow-release Idose TR arms, respectively, compared with 7.8 mmHg (30%) in the timolol group. The two-year data also showed 23% and 20% of patients in the fast- and slow-elution Idose TR arms saw at least a 40% drop in IOP, vs 13% in the timolol arm. The data also support Idose TR’s safety, with no significant adverse events.

Glaukos is in the process of enrolling about 1,100 patients in a phase 3 trial of Idose TR, being conducted at close to a hundred, mostly U.S. sites. The company anticipates filing a new drug application for the treatment in 2022, with FDA approval in 2023.

Burns underscored the product’s convenience appeal – one administration per year vs. 1,460 eye drops. He pegged the potential market for Idose TR at 3 million in the U.S.

“We believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and durable sustained-release pharmaceuticals to traditional topical medications,” he said. “These data reaffirm our excitement about the potential commercial prospects of Idose TR.”

Pipeline prospects

Glaukos portfolio of MIGS devices includes the FDA-approved Istent, Istent Inject and Istent Inject W, which includes two preloaded stents. The Istent Inject is also approved in the E.U., Canada, Australia and several other international markets.

The company’s pipeline includes several new glaucoma products. Glaukos is the exclusive U.S. distributor for Santen Pharmaceutical Co.’s Preserflo Microshunt, a standalone alternative to trabeculectomy and tube shunts. It is expected to launch in the second quarter of this year, pending FDA approval. Glaukos is also developing Iprime, a minimally invasive viscodelivery system and an IOP sensor.

Next-generation versions of Idose, Idose Trex and Idose Rock, are also in the works, with estimated commercialization in 2023-2024 and 2025 or later, respectively.

Meanwhile, Glaukos reported preliminary revenue of $73 million for the fourth quarter of 2020, consisting of $58 million in glaucoma sales and $15 million in corneal health sales. Full-year sales are projected at $225 million, $179 million from glaucoma and $46 million from corneal health.

The Q4 results beat consensus estimates of $67.2 million, comprised of $55 million in glaucoma and $12.1 million in corneal health, noted BTIG analyst Ryan Zimmerman. “We were looking for $56.8 million/$7.0 million, which suggests far stronger growth in Corneal Health than we anticipated.”

Glaukos shares (NYSE:GKOS) rose on the positive reports, closing Wednesday up 8.02% at $84.18.