Glaukos (NYSE:GKOS) touted data today from a 53-patient glaucoma study showing that its iStent device combined with topical travoprost reduced mean intraocular pressure by 35% after 18 months of follow-up.
The company’s flagship device is designed to lessen IOP by restoring the natural outflow of aqueous humor through the conventional pathway in a patient’s eye.
All 53 participants in this study had open-angle glaucoma that was not controlled on 2 topical drugs, according to Glaukos. The preoperative, medicated mean IOP was 19.7 mm Hg. Patients began a regimen of topical travoprost 1 day after 2 iStent devices were implanted in their eye in a standalone procedure.
No device-related adverse events were reported through 18 months, Glaukos said. The company touted that at 1 year, 91% of eyes met at least a 20% decrease in IOP with the reduction of 1 drug. Also, 100% of eyes experienced IOP of less than or equal to 18 mm Hg and 87% of eyes achieved IOP less than or equal to 15 mm Hg after 1 year.
“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,” lead author Dr. John Berdahl said in prepared remarks. “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.”
The company also said it is evaluating a travoprost intraocular implant in a Phase II investigational new drug trial. The iDose delivery system is designed to continuously elute a particular concentration of travoprost for an extended length of time.
“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,” president & CEO Thomas Burns said in prepared remarks. “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.”