Glaukos, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced the completion of patient enrollment in its US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial for the iStent infinite Trabecular Micro-Bypass System.
The iStent infinite is designed for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in refractory glaucoma patients. It includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of five to six clock hours around Schlemm’s canal, the eye’s primary drainage channel. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor. The iStent infinite is similar to the company’s two-stent iStent inject® Trabecular Micro-Bypass System, which was approved by the FDA in June 2018 for the reduction of IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.
The iStent infinite prospective, unmasked, multi-center, single-arm clinical trial enrolled subjects who had undergone prior unsuccessful incisional glaucoma surgery and had IOP not adequately controlled with currently tolerated topical ocular hypotensive medications as well as subjects who had not undergone prior incisional glaucoma surgery but were on maximally tolerated topical ocular hypotensive medications with uncontrolled IOP. In the trial, 72 subjects were implanted with the iStent infinite at 15 separate clinical sites. All surgeons performing the iStent infinite procedures were board-certified glaucoma specialists.
The trial’s primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months postoperative on the same or fewer topical ocular hypotensive medications. Glaukos plans to use the trial results as the basis for seeking FDA approval of the iStent infinite.
“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, Glaukos president and chief executive officer. “We appreciate the commitment and dedication of the clinical investigators, who play a vital role in bringing new innovations to patients suffering with advanced glaucoma disease and at risk for significant vision loss. 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 pioneered Micro-Invasive Glaucoma Surgery (MIGS), which involves insertion of a micro-scale device from within the eye’s anterior chamber through a small corneal incision. Glaukos’ MIGS devices are designed to reduce IOP by restoring the natural outflow pathways for aqueous humor. Glaukos received FDA approval for its first-generation MIGS device, the iStent, in 2012. Its second-generation iStent inject, approved by the FDA in 2018, includes two stents preloaded in an auto-injection mechanism that facilitates stent insertion into multiple trabecular meshwork locations through a single corneal incision. The iStent inject is also approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Korea, Singapore and other international markets. Glaukos is pursuing FDA approval for additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the United States.
Indication for Use: The iStent inject Trabecular Micro-Bypass System Model G2-M-IS is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma.
Contraindications: The iStent inject is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
Warnings: Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard.
MRI Information: The iStent inject is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details.
Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents.
Adverse Events: Common postoperative adverse events reported in the randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%).
Source: Company Press Release
