Data from the study was recently published in the Journal of Glaucoma, the Laguna Hills, Calif.-based company said.
Glaukos’ iStent micro-bypass stents are made from non-ferromagnetic titanium and coated in heparin, is designed to be implanted into multiple trabecular meshwork through a single corneal entry point to reduce IOP, the company said. Pseudophakic eyes are eyes in which the natural lens has been removed and replaced with an intraocular lens.
Data from the retrospective, consecutive case series explored outcomes in 42 procedures in which the iStent device was implanted in pseudophakic eyes with preoperative mean intraocular pressures of 20.26 mm Hg. After 2 years, 21 eyes treated with the iStent reported a mean medicated IOP decrease of 6.64 mm Hg, down 33%
A total 96% of patients with preoperative medicated IOP of greater than or equal to 19 mm Hg reported a reduction in IOP on their last follow-up. Only 1 patient required additional glaucoma surgery, Glaukos said, commenting that the “safety profile was favorable.”
“While multiple studies and years of real-world experience have demonstrated the ability of iStent to achieve sustained IOP reductions when used in combination with cataract surgery, we wanted to explore the IOP-lowering performance of iStent as a sole procedure in pseudophakic eyes. In this series of iStent procedures occurring between October 2012 and May 2015, we recorded IOP reductions at one and two years postoperatively that were both clinically and statistically significant. These types of results are important to glaucoma surgeons and patients because landmark studies such as the early manifest Glaucoma trial have shown that every 1 mm Hg improvement in IOP can reduce the likelihood of disease progression,” study investigator Dr. John Berdahl, who performed all of the procedures in the study, said in a press release.
In September, Glaukos released 3-year results from a study of its iStent, touting a 43% reduction in mean intraocular pressure in glaucoma patients treated with the device. Results were published in the journal Ophthalmology and Therapy.
Data in the prospective study came from 101 patients with primary open-angle glaucoma at a single investigational site, who received either 2 iStents or topical travoprost. Results indicated a mean IOP reduction of 43% for patients treated with the iStent, reduced from 25.5 mm Hg to 14.6 mm Hg. Data from the travoprost arm indicated a 39% reduction in IOP, moving from 25.1 mm Hg to 15.3 mm Hg.
A total 23% of the patients treated with travoprost required additional topical medication therapy, compared with 11% of patients treated with iStent, according to the study. Mean intraocular pressure was reported at 18 mm Hg or below for 91% of the patients in the stent group without the need for additional topical meds, and 79% for patients in the travoprost group.