Glaukos touts 5-year study of glaucoma stents

Glaukos  (NYSE:GKOS) said today that a study of its iStent trabecular micro-bypass stents reduced eye pressure in glaucoma patients five years after implant. The same study showed that significantly fewer iStent patients needed add-on medications after five years, the company said.

The study showed that newly diagnosed, primary open-angle glaucoma (POAG) patients who received two iStents achieved a 35.3% reduction in mean intraocular pressure (IOP) to 16.5 mmHg. The prospective, controlled, multi-surgeon clinical trial pitted evaluated the five-year safety and efficacy of two iStents vs. topical prostaglandin as an initial intervention in POAG subjects who had not had prior glaucoma treatment. A total of 101 subjects were randomized in a 1:1 ratio to receive either two iStents in a standalone procedure or once-daily topical travoprost, a commonly prescribed prostaglandin. The results were published in Ophthalmology Glaucoma.

Treatment success — defined as mean diurnal IOP of 6 mmHg to 18 mmHg without add-on medication or secondary glaucoma surgery — was achieved in 77% of stent eyes vs. 53% of travoprost eyes (p = 0.04). Seventeen percent of stent eyes vs. 44% of travoprost eyes required add-on medication.

The need for add-on medication arose at a slower rate in the stent group than in the travoprost group, especially after two years of follow-up. Study authors observed that from two to five years of follow-up, add-on medications were initiated in roughly double the number of travoprost eyes vs. stent eyes. The safety profile was excellent in both groups throughout follow-up, according to the San Clemente, Calif.-based company.

“Topical ocular hypotensive medications are typical first-line glaucoma therapy but these drugs can be ineffective due to high rates of patient non-adherence, ocular surface damage, cost and other factors,” said ophthalmic surgeon and lead author Dr. Robert Fechtner in a prepared statement from Glaukos. “This study shows that not only are Glaukos’ iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.”

Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here.

“This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients,” said Glaukos prez & CEO Thomas Burns. “Moreover, it adds meaningful outcomes data to the growing body of peer-reviewed evidence that implantation of a single or multiple iStents can reliably achieve sustained IOP reductions in an elegant, tissue-sparing procedure with a highly favorable safety profile.”

Today’s announcement was good news for Glaukos, whose iStent recently fared worse in a two-year study that compared it to competitor Ivantis’ Hydrus Microstent. The Ivantis study touted reductions in medication use and no reoperations for patients in the Hydrus arm.

 

 

 

Ivantis touts 2-year Hydrus, Glaukos iStent head-to-head study results

IvantisIvantis today released two-year results from a study comparing its Hydrus Microstent to Glaukos‘ (NYSE:GKOS) iStent trabecular micro-bypass stents, touting reductions in medication use and no reoperations for patients in the Hydrus arm.

The Irvine, Calif.-based company said that it is presenting results from the Compare trial today at the American Glaucoma Society’s annual meeting in San Francisco.

“We are extremely pleased with these two year results. These results illustrate the clinical advantages of the Hydrus and its unique, proprietary Tri-Modal mechanism of action relative to focal trabecular bypass.  Clearly, scaffolding the canal has unique benefit.  Of the over 100 peer reviewed publications in the MIGS space, there are only a small handful of prospective, multicenter randomized trials, and Ivantis has conducted nearly half of those, which is a significant achievement for a company that is the most recent to commercialize in the MIGS category.  We are proud to sponsor clinical trials of this caliber, enabling the Compare investigators to advance our understanding of the Hydrus Microstent and the MIGS field overall, and we look forward to the publication of these important two year results. We are grateful to the investigators for their support and contributions,” prez & CEO Dave Van Meter said in a press release.

In the study, Ivantis compared the Hydrus microstent against two large-diameter iStent devices in treating open-angle glaucoma in a stand-alone procedure. A total of 152 patients with mild to late-moderate stage disease were treated at 12 international centers in the trial by surgeons who were “beyond their surgical learning curves for both devices,” the company said.

Results at 24 months indicated that 38% of patients treated with the Hydrus device were medication free, compared to 18.7% of patients in the iStent groups. Medication use was reduced by 1.3 medications, or 52%, on average for Hydrus patients, while iStent patients saw reductions of 0.8, or 29%, Ivantis said.

No Hydrus patients required reoperation to control for glaucoma, while 9% of patients in the iStent group required reoperations, the company said. A total 63% of patients in the Hydrus arm achieved a 20% reduction in intraocular pressure while on fewer meds, compared to 40% of iStent patients. Both groups reported general stability in medication reductions and IOP levels relative to their results at 12 months, the company added.

“The clinical community will be pleased to see 24-month results for the first controlled ‘head-to-head’ trial in the MIGS space, and there are some important and practical takeaways here.  First, although this is a controlled trial, it is quite ‘real world’ in the sense that the surgeons were trained experts in both technologies and the population included a wide range of disease severity.  Second, we know cataract surgery alone is effective at reducing IOP, and, while the predominant application of MIGS today is in conjunction with cataract surgery, the results of this trial allows us great optimism for the role of these technologies as ‘standalone’ procedures.  Third, while not a prespecified endpoint, a critical finding was a statistically significant difference in secondary surgical interventions at 2 years in favor of Hydrus.  Ultimately, the goal of all MIGS – and all glaucoma therapy in general – is to stop progression of disease.  While both devices had overall benefit for the patient, on this metric, Hydrus as a stand-alone procedure was excellent.  This data set is an important contribution to our overall understanding of the role of MIGS devices in our armamentarium,” American Society of Cataract and Refractive Surgeons prez Dr. Thomas Samuelson said in a prepared statement.

Last August, Ivantis said that it won FDA approval for its Hydrus microstent designed to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.

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Ivantis touts 1-year head-to-head Hydrus, iStent study data

Ivantis today released one-year results from the study of its Hydrus Microstent comparing it to Glaukos‘ (NYSE:GKOS) iStent trabecular micro-bypass stents, touting the Hydrus’ ability to reduce reliance on medication and intraocular pressure.

Results from the trial were presented at the American Society of Cataract and Refractive Surgery annual meeting in Washington D.C. by Dr. David Chang of the University of California, San Francisco, Irvine, Calif.-based Ivantis said.

The Hydrus microstent is designed for minimally invasive microsurgical procedures to reduce eye pressure in patients with glaucoma. The device is multi-modal, the company said, by creating a large opening through the trabecular meshwork and dilating and scaffolding the conventional pathway through which fluid exits the eye.

“This is a necessary, novel and well-run study conducted by a group of experts in the field of MIGS. Not only is it the first to compare two different canal-based technologies in a Level One evidence clinical trial, but it is the first prospective, randomized data reported where we can evaluate MIGS devices in a standalone glaucoma setting. These MIGS approaches, when combined with cataract surgery, have been previously reported to be safe and effective. This study looks at the viability of MIGS in patients who don’t need or may have already had cataract surgery, so it’s a vital addition to our growing body of evidence supporting MIGS,” Compare trial medical monitor Dr. Iqbal Ahmed said in a prepared release.

Ivantis said the 152-patient trial was the first to compare two minimally invasive glaucoma surgery device for treating open-angle glaucoma in a standalone procedure. The study aimed to compare safety and effectiveness of both devices in lowering IOP and reducing eye-drop medication.

Results at one year showed that 47% of eyes treated with the Hydrus Microstent were medication free, compared to 24% of eyes treated with the iStent device. Medication use was reduced by 61% for Hydrus patients, the company reported, with a 37% reduction for patients treated with the iStent.

A total of 73% of patients who received the Hydrus stent achieved a 20% reduction in IoP while on fewer medications, compared to 47% in the iStent cohort.

“To date, we have had no comparative data from prospective randomized studies evaluating two different MIGS devices. Furthermore, we have had very few, if any, level one evidence clinical trials assessing MIGS in a standalone glaucoma surgery setting. Compare is not only a multi-center study but also a ‘real world’ MIGS assessment, given the wide range of glaucoma severity and the fact that 12 experienced, expert surgeons from eight countries participated. It is notable that participation criteria required that all surgeons were past the learning curve for each MIGS platform. The Compare data will be helpful in evaluating canal-based MIGS in a wide range of clinic situations, and it will demonstrate the benefit of dilating Schlemm’s canal and gaining access to multiple outflow collector channels. I look forward to the peer-reviewed publication of these results and further analysis with longer follow-up,” Ivantis global medical monitor Dr. Thomas Samuelson said in prepared remarks.

“These results illustrate the clinical advantages of the Hydrus and its unique, proprietary tri-modal mechanism of action. Combined with best-in-class data in the cataract surgery setting, this adds to what we believe is the broadest and highest-level evidence seen to date for a MIGS device. We are proud to sponsor clinical trials of this caliber, enabling the Compare investigators to advance our understanding of the Hydrus Microstent and the MIGS field overall, and we look forward to the publication of these important results. We are grateful to the investigators for their support and contributions,” prez & CEO Dave Van Meter said in a press release.

Last April, Ivantis said it won approval from the FDA to initiate a 2nd investigational device exemption trial of its Hydrus microstent, testing the device in patients with advanced glaucoma who are undergoing stand-alone glaucoma surgery without combined cataract surgery.

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