Combining Implantation of Glaukos iStent inject® Trabecular Micro-Bypass with Topical Travoprost Provides Sustained IOP Reduction and Favorable Safety Profile, According to New Study

Business Wire: June 21, 2017 – SAN CLEMENTE, CA, U.S.A. – Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, today announced that a study of 53 open-angle glaucoma subjects recently published in Clinical and Experimental Ophthalmology showed that the iStent inject® trabecular micro-bypass, combined with topical travoprost, delivered a 35% reduction in mean intraocular pressure (IOP) to 12.9 mm Hg after 18 months of follow-up.

All subjects enrolled in this prospective, international study had open-angle glaucoma not controlled on two preoperative topical medications. The preoperative medicated mean IOP was 19.7 mm Hg. One day after implantation of two iStent inject stents in a standalone procedure, all subjects began a regimen of topical travoprost, which is a commonly prescribed ocular hypotensive medication. A total of 11 surgeons performed the procedures, and no device-related adverse events occurred through 18 months. In addition:

• At 12 months, 91% of eyes achieved a ≥20% decrease in IOP with the reduction of one medication.

• At 12 months, 100% of eyes achieved IOP ≤ 18 mm Hg, and 87% of eyes achieved IOP ≤ 15 mm Hg, with the reduction of one medication.

• Following medication washout at 13 months, mean unmedicated IOP decreased 33% to 16.6 mm Hg, versus 24.9 mm Hg preoperatively.

“The results of this study underscore the viability of using iStent inject together with a single postoperative prostaglandin medication to consistently manage IOP to levels in the 15 mm Hg range,” said John Berdahl, M.D., who authored the article. “What’s more, the study washouts show the independent capability of iStent inject to significantly lower IOP without any benefit from topical medications. This is important because we know that glaucoma patients often don’t adhere to topical medication treatment regimens.”

Glaukos is the study sponsor and the pioneer of Micro-Invasive Glaucoma Surgery, or MIGS. The company’s flagship MIGS device, the iStent® trabecular micro-bypass stent, was approved by the U.S. Food & Drug Administration (FDA) in 2012. Inserted through a small corneal incision made during cataract surgery, the iStent is designed to reduce IOP by restoring the natural physiological outflow of aqueous humor through the conventional pathway.

Glaukos’s next-generation iStent inject device is designed to deploy two stents into separate trabecular meshwork locations for enhanced IOP reduction and procedural ease. Two versions of the iStent inject—for combination-cataract and standalone indications—are currently being evaluated in FDA clinical trials for IOP reduction. The iStent inject is approved for use in the European Union, Canada, Australia, Brazil, and Singapore.

Glaukos is also evaluating a travoprost intraocular implant with the iDose™ delivery system in a phase II Investigational New Drug (IND) trial. Implanted during a micro-invasive procedure, the iDose is designed to continuously elute therapeutic levels of a proprietary formulation of travoprost for extended periods of time. Travoprost is designed to increase outflow primarily through the uveoscleral, or unconventional, pathway, and to a lesser extent through the conventional pathway. When the implant’s medication is depleted, the implant can be removed and replaced in a similar micro-invasive procedure.

“These results add to the growing body of peer-reviewed data that demonstrate the power of multiple trabecular bypass stents to control IOP and reduce patients’ reliance on topical medications,” said Thomas Burns, Glaukos president and chief executive officer. “Moreover, this study helps to illustrate the advantages of harnessing both the conventional and unconventional outflow pathways in order to effectively manage IOP in glaucoma patients.”

Glaukos (www.glaukos.com) is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent® , its first MIGS device, in the United States in July 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent, measuring 1.0 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA.