Glaukos (NYSE:GKOS) today released data from a 3-year study of its iStent travecular micro-bypass stent, touting sustained reductions in intra-ocular pressure after treatment with 2 of the devices.
The study was published in the November issue of the Clinical Ophtalmology journal, the company said.
The iStent trabecular micro-bypass stent is a tiny titanium stent designed to alleviate intra-ocular pressure caused by glaucoma and indicated for use in conjunction with cataract surgery.
“Our study shows that sustained IOP reduction to 15 mmHg is possible after implantation of multiple iStent devices in a standalone procedure. Of particular note is that the IOP reduction in these patients was accomplished without concomitant cataract surgery, showing that the efficacy of iStents is significant and separate from the IOP reduction associated with cataract surgery. Moreover, nearly 90% of patients in the study were medication free three years following the procedure. Because glaucoma management is often a challenge due to the poor compliance and side effects associated with topical medications, a safe and effective stent procedure that enables sustained reduction in IOP may be a preferable alternative to glaucoma patients and their physicians,” Dr. Eric Donnenfeld said in a press release.
The 39 patient prospective pilot study reported a mean intra-ocular pressure of 15.2 mmHg in unmedicated patients treated with 2 iStent devices, a 37% reduction from their baseline after 36 months. In 4 medicated subjects, IOP ranged from 13 mmHg to 15.7 mmHg after 36 months.
Glaukos reported 1 postoperative case of hyphema that was resolved at 1 week, and no other postoperative device-related adverse events.
Late last month, Glaukos said it agreed to settle a patent infringement lawsuit brought by eye stent rival Transcend Medical.
The agreement, in which both sides agree not to sue for patent infringement, calls for Transcend to pay a 1% royalty on sales of its Cy-Pass micro-stent until April 2022, with the total amount capped at $6 million, Glaukos said.
The deal does not cover stents designed to relieve eye pressure by unconventional outflow pathways, the company said, meaning its iStent Supra suprachoroidal micro-bypass stent is not bound by the covenant.
