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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Glaukos rises on Street-beating Q4, 2018 earnings

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Shares in Glaukos (NYSE:GKOS) are rising today after the ophthalmological-focused medical device maker posted fourth quarter and full year 2018 earnings that topped expectations on Wall Street.

The San Clemente, Calif.-based company posted profits of approximately $1.8 million, or 4¢ per share, on sales of approximately $54.1 million for the three months ended December 31, for bottom-line growth of 76.8% while sales grew 29.8% compared with the same period during the previous year.

Read the whole story on our sister site, Drug Delivery Business News

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Glaukos posts red ink in Q1 earnings

Shares in Glaukos (NYSE:GKOS) have fallen today after the ophthalmic medical tech company posted first quarter earnings that saw profits swing to losses, despite topping The Street’s expectations.

The San Clemente, Calif.-based company posted losses of $2.7 million, or 8¢ per share, on sales of $40.1 million for the three months ended March 31, seeing an over 400% swing into red on the bottom-line while sales grew 11.8% compared with the same period during the previous year.

Read the whole story on our sister site, Drug Delivery Business

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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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Glaukos touts 2-year iStent inject pivotal trial data, levies infringement suit against Ivantis

Glaukos (NYSE:GKOS) today released two-year data from the FDA investigational device exemption pivotal trial of its iStent inject trabecular micro-bypass system, and announced a patent infringement suit it filed against Ivantis.

Results of the 505-patient study were presented at the American Society of Cataracts and Refractive Surgery annual meeting by Dr. Thomas Samuelson of the Minnesota Eye Consultants, the San Clemente, Calif.-based company said.

The iStent inject trabecular micro-bypass system is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It uses a pair of heparin-coated titanium stents in a pre-loaded auto-injection system that allows them to be injected into multiple trabecular meshwork locations via a single corneal entry point, the company said.

In the trial, subjects were randomized to two cohorts, with 387 patients receiving the iStent inject in combination with cataract surgery and 118 patients receiving cataract surgery only. Subjects in the trial were followed through two years with annual medication washouts, the company said.

Glaukos said that the trial met its primary and secondary effectiveness endpoints, and reported that the overall rate of adverse events between groups was similar.

At two years, 75.3% of the cohort who received the iStent inject achieved a 20% or greater reduction in unmedicated intraocular pressure compared to 61.9% in the cataract-surgery-only cohort. Mean unmedicated IOP amongst iStent patients was 6.9 mmHg compared to 5.4 mmHg for the cataract-only cohort.

Data indicated that at two years, the iStent inject cohort had a 31% mean reduction in unmedicated IOP of 17.11 mmHg from a baseline of 24.8 mmHG and that 62.6% of the cohort achieved an unmedicated mean IOP at or below 18 mmHg, compared to only 49.2% in the cataract-surgery-only cohort.

“The IOP-lowering capability of a single iStent in combination with cataract surgery has been well documented in the clinical literature, while various published studies and real-world international experience have also shown that multiple iStent devices can provide incremental IOP-lowering benefits. Given its performance and enhanced ease-of-use, we believe the iStent inject, if approved by the FDA, will be an attractive, two-stent option for U.S. ophthalmic surgeons to reliably manage glaucoma patients’ IOP in a straightforward and effective manner,” prez & CEO Thomas Burns said in a press release.

In a separate release, Glaukos announced it filed a patent infringement suit in the US District Court for the Central District of California, Southern division, against competitor Ivantis.

In the suit, the company claims that Ivantis’ Hydrus Microstent device infringes on patents Glaukos owns related to its core glaucoma technology.

“Since our founding in 1998, Glaukos has invested considerable time and resources to develop novel technologies that create entirely new treatment options for glaucoma surgeons and their patients. This lawsuit reflects our unwavering commitment to protect our proprietary inventions for the benefit of patients, customers, shareholders, employees and others who rely on us,” CEO Burns said in a prepared statement.

In February, Glaukos released results from a study of its iStent trabecular micro-bypass stent exploring its use during cataract surgery in patients with severe open-angle glaucoma, touting significant reductions in intraocular pressure and medication use.

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Glaukos touts IOP, medication use reductions in iStent trial

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Glaukos (NYSE:GKOS) today released results from a study of its iStent trabecular micro-bypass stent exploring its use during cataract surgery in patients with severe open-angle glaucoma, touting significant reductions in intraocular pressure and medication use.

The San Clemente, Calif.-based company’s 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.

Results were published in the January issue of the Journal of Glaucoma.

“Although the iStent is currently indicated for use in the United States during cataract surgery in mild to moderate glaucoma patients, this study offers important insights into the potential for ourtechnology platform to ultimately serve a full range of glaucoma disease states and progression,” prez & CEO Thomas Burns said in a prepared statement.

Data in the study came from 59 glaucomatous eyes with cataracts and severe visual field loss, recording a baseline medicated mean IOP of 19.3 mm Hg and mean topical glaucoma medication use per eye of 2.3.

A total of 49 eyes were followed out to two years after implantation, with mean postoperative IOP decreasing to 14.9 mm Hg and mean glaucoma medication use dropping to 1.6. IOP reduction was maintained in a consistent cohort of 32 eyes with data available through three years, with a postoperative IOP of 14.1, down from 18.1.

No intraoperative complications were noted among 59 eyes in the series, with four patients requiring additional surgery.

“While many prior studies have documented the clinical benefits of combining iStent implantation with cataract surgery in glaucoma patients who are in the mild to moderate stage of the disease, we believe this is the first published study to focus on its use in severe glaucoma patients undergoing cataract surgery. Our study showed that severe glaucoma patients experienced sustained reductions in IOP and medication use through three years postoperative,” study author Dr. John Berdahl said in a press release.

Last month, Glaukos released results from a Phase II trial of its travoprost intraocular implant in a 12-month cohort of glaucoma patients.

Glaukos shares fall despite Q3 beat

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Glaukos logoShares in Glaukos (NYSE:GKOS) fell today even though the ophthalmic medical device maker topped expectations on Wall Street with its third quarter results.

The San Clemente, Calif.-based company posted profits of $1.3 million on sales of $40.4 million for the 3 months ended Sept.30, for bottom-line growth of 8.3% on sales growth of 36.5% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were 4¢, ahead of consensus on The Street, where analysts were looking for sales of $39.1 million.

“As the pioneer of micro-invasive glaucoma surgery, Glaukos continued in the third quarter to establish this new treatment class through global adoption of our iStent trabecular micro-bypass and next-generation iStent inject trabecular micro-bypass,” president & CEO Thomas Burns said in prepared remarks.

“This initial stage of our development is providing a solid foundation for our future growth and market expansion as we advance our comprehensive pipeline of breakthrough surgical and sustained pharmaceutical systems designed to address the full range of glaucoma disease progression and severity.”

Glaukos said it expects it post $155 million to $160 million in sales for the full year.

GKOS shares were trading at $30.18 apiece today in afternoon activity, down -4.2%.

7 medtech stories we missed this week: March 24, 2017

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From companies receiving CE marking to other companies adjusting their distribution deals, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. Viveve Medical closes public offering

Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. The public offering price was $4 per share, and the company estimates that the net proceeds from the offering will be nearly $31.7 million after deducting underwriting discounts and commissions.

2. Masimo receives CE Mark for Rad-97 Pulse CO-Oximeter

Masimo announced that it received CE Marking for its noninvasive blood pressure measurements from its Rad-97 Pulse CO-Oxumeter and connectivity hub, according to a March 20 news release. Rad-97 allows clinicians to measure arterial blood pressure in adults, pediatric and neonatal patients. It measures using 3 measurement modes: spot-check, automatic interval and stat interval. The built-in port lets clinicians connect a blood pressure cuff inflation hose right on the Rad-97. It also enables easy and automatic charting of blood pressure data directly from the same monitoring device that measures oxygen saturation, total hemoglobin and other noninvasive parameters. The device has WiFi and Bluetooth connectivity that allows the device to connect to other devices that are nearby. With its user-friendly multi-touch navigation, clinicians can customize the high-resolution, 1080p HD color display to what they need.

3. Glaukos announces reimbursement win

The opthalmic medical technology company Glaukos Corp. has announced that the Current Procedural Terminology (CPT) Editorial Panel of the American Medical Association has given it a 5-year extension to 3 Category III CPT codes that describe insertion of aqueous drainage devices into the anterior chamber of the eye during micro-invasive glaucoma surgery, according to a March 16 news release. Physicians and other healthcare providers use CPT codes to report and receive Medicare reimbursement for services. The 3 CPT codes that received an extension are 0191T, 0253T and 0376T, all of which deal with the iStent device.

4. DiamiR wins $2.75 million grant for Alzheimer’s biomarker diagnostic device

DiamiR announced in a March 15 news release that it was awarded a $2.75 million Small Business Innovation Research (SBIR) Phase IIB grant from the National Institute on Aging and the National Institutes of Health. The grant is going toward supporting the development of DiamiR’s targeted diagnostic technology that analyzes brain-enriched microENA biomarkers in plasma to detect Alzheimer’s disease. The grant will stretch over a 3 year period and builds on to the company’s earlier studies that received SBIR Phase I and SBIR Phase II grants.

5. Flowonix and Cerebral Therapeutics launch clinical trial

Flowonix and Cerebral Therapeutics announced that the first patients of its clinical trial have had the Prometra implanted, according to a March 14 news release. The clinical trial, called ADDRESS, is the first multi-center dose ranging clinical study that evaluates intracerebroventricular (ICV) delivery of the drug valproate in patients who have focal seizures and have a temporal lob onset with to without secondary generalization. The study includes 9 patients who will undergo this treatment and will receive the valproate from the Flowonix Prometra II Programmable Pump.

6. Bonesupport extends U.S. bone Cerament distribution deal

Bonesupport has extended the terms of its U.S. distribution agreement with Zimmer Biomet, according to a March 14 news release. Zimmer Biomet will continue to have exclusive rights to Sonesupport’s Cerament Bone Void Filler designed for orthopedics, trauma and foot and ankle indications in the U.S.

7. Ortho Clinical Diagnostics and Astute Medical extend partnership

Ortho Clinical Diagnostics has expanded its agreement with Astute Medical for its NephroCheck Test distribution, according to a March 13 news release. The NephroCheck Test is a biomarker-based test that asses the risk for acute kidney injury. This new agreement gives Ortho Clinical Diagnostics the distribution rights in more European countries. Astute Medical gave Ortho a license to develop and market the NephroCheck Test in the U.S. and certain countries in Europe in 2014.

Here’s what we missed last week.