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.

 

 

 

Second Sight Medical releases early feasibility data on Orion cortical implant

Second Sight Medical's Orion cortical implantSecond Sight Medical (NSDQ:EYES) today announced preliminary results from a small feasibility study of its Orion cortical implant, which is designed to give eyesight to the blind.

Sylmar, Calif.-based Second Sight’s Orion is designed to connect the camera in a pair of eyeglasses with an implant that receives the camera signal and translates it to the visual cortex in the brain, bypassing the eye and the optic nerve entirely. The company’s Argus II device, which uses a retinal implant to receive the camera’s signal, is already on the U.S. market.

Interim data from a five-year early feasibility study, presented today at the annual meeting of the Brain Research through Advancing Innovative Neurotechnologies conference in Washington, D.C., involved five patients with bilateral blindness from any cause other than damage to the visual cortex.

The primary safety outcome for the study is the rate of adverse events, with secondary outcomes including phosphene production, long-term device function, benefit to visual function and quality of life. The first subject was implanted  in January 2018.

The study showed a significant improvement in the ability to locate a high-contrast target for three of five subjects at six months. Two of the five patients showed significantly better at determining the direction of motion of a high-contrast target. All five patients were rated by certified specialists as having improved functional vision and well-being.

“Observations from rehabilitation sessions include that subjects are able to use Orion to visually detect parked cars, identify the direction of motion of a person walking by, and visually order small objects by size,” Second Sight said.

There was one serious adverse event when a patient had a seizure and four non-serious adverse events, the company said, noting that there were no unanticipated adverse device effects as of Feb. 8.

“We are delighted to share preliminary Orion feasibility study findings with this esteemed group of investigators. This conference provides a forum for discussing exciting advancements and to continue to engage with other scientists who are conducting cutting-edge research in the field,” president & CEO Will McGuire said in prepared remarks. “We are encouraged by the progress Orion subjects are making on visual function endpoints like square localization and direction of motion. With the help of our highly-trained low-vision specialists, our subjects are using Orion at home to perform everyday visual tasks that they cannot do without the system. We look forward to completing the analysis of 12-month data from the Orion Early Feasibility Study and to future refinements that enhance Orion’s ability to provide useful artificial vision to blind individuals.”

Presbia delays Flexivue Microlens FDA PMA approval timeline again

Presbia (NSDQ:LENS) has delayed the timeline for approval of its Flexivue Microlens for treating far-sightedness again due to an earlier request for more information from the FDA.

The Irvine, Calif.-based company was told last October that it had 180 days to provide the agency with 36-month data from all subjects enrolled in the staged pivotal clinical trial, as well as additional safety and efficacy information, before it can complete its premarket approval application review, according to an SEC filing.

Presbia submitted its final pre-market approval module to the FDA during the second quarter of last year, including 24-month data for the Flexivue device, saying it expected the PMA bid to go through during the fourth quarter of 2018 before submitting final 36-month data during Q1 2019.

But the agency said on October 5 that it would require the 36-month data before it could finish its review of the PMA, Presbia said in an Oct. 12 SEC filing. The federal watchdog gave the company until April 3, 2019 to respond.

This week, Presbia said that it still needs additional time to submit the data to the FDA, and added that it got a 180-day extension, according to an SEC filing.

The company said that it expects it will complete the submission of the extra information before the September 30 extension date, but added that there is “no assurance” that it will be granted PMA approval, according to the filing.

Shares in Presbia have fallen 1.7% so far today, at 68¢.

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FDA accepts second application for Ocular Therapeutix’s drug-delivering implant

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery.

The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is positioning its product as a way to eliminate the current standard of care for post-surgical pain – topical steroid eye drops.

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

Sight Sciences

Sight SciencesSight Sciences said today that it launched a clinical trial of its Omni eye surgery device in sequential, minimally invasive glaucoma procedures.

Menlo Park, Calif.-based Sight Sciences said the 130-patient Gemini study is designed to evaluate the use of Omni in consecutive MIGS procedures involving transluminal viscoelastic delivery and trabeculotomy at 12 months. The single-arm trial’s primary outcomes are change in mean unmedicated diurnal intraocular pressure and change in mean number of IOP-lowering drugs. Secondary outcomes include percent of eyes with a more than 20% reduction in unmedicated diurnal IOP and percent of eyes with unmedicated diurnal IOP between 6mmHg and 18mmHg. The safety endpoints are the rate of ocular adverse events and best corrected visual acuity, according to ClinicalTrials.gov.

The estimate primary completion date is August 2020, with final completion slated for December next year.

“Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with performing multiple MIGS procedures during one surgery. Our goal of intervening earlier in the disease stage with multiple mechanisms of action is to generate the most efficacy possible while maintaining the optimal safety profile of MIGS,” Dr. Steve Vold, who performed the study’s first procedures, said in prepared remarks. “The Omni surgical system targets the three points of resistance in the conventional outflow pathway; this medical technology has the potential to become a leading option in the MIGS space.”

“Sight Sciences is committed to building upon a strong foundation of scientific evidence to help inform surgeons’ clinical decisions and help them select technologies that are best suited for their individual patients,” added chief medical officer Dr. Reay Brown. “We look forward to further confirming – via this large-scale, prospective, multicenter trial – that our sophisticated technology offers a compelling alternative to traditional treatments.”

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Johnson & Johnson touts drug-releasing lens studies for itchy eyes

Johnson & JohnsonContact lenses imbued with an antihistamine drug reduced itchy eyes in a pair of older studies funded by the vision business at Johnson & Johnson(NYSE:JNJ), the company said today.

The Phase 3 studies, conducted in 2007, involved a total of 244 patients, divided into three cohorts. In the first patients wore a plain lens made of etafilcon a in one eye and the same lens treated with 0.019mg of the drug ketotifen in the other eye. In the second group, patients wore treated lenses in both eyes; the third group was the control, consisting of patients wearing placebo lenses in both eyes. There were about 40 subjects in each group.

Get the full story at our sister site, Drug Delivery Business News.

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Novartis’ Alcon picks up PowerVision for $285m

Alcon, PowerVision

Novartis (NYSE:NVS) subsidiary Alcon said today that it acquired intraocular lens developer PowerVision for $285 million.

PowerVision is developing fluid-based intraocular lens implants that use the eye’s natural accommodating response to transport fluid in the implanted lens, Fort Worth, Texas-based Alcon said.

The fluid-based lens creates a continuously variable monofocal lens using the natural contractions of the eye’s muscles, Alcon said, allowing a patient to actively focus on objects in a style similar to a young eye’s crystalline lens.

“We’re thrilled to officially join Alcon and its pioneering history of launching new innovation in the field of ophthalmology. We look forward to bringing this innovative IOL technology to eye care providers and customers in the years ahead,” PowerVision prez & CEO Barry Cheskin said in a prepared statement.

Alcon said that the commercial availability of the newly acquired IOL devices will be “determined following significant additional development and clinical trials of the intraocular lens.

The deal includes additional payments tied to regulatory and commercial milestones slated to begin 2023, Alcon said.

“As the industry leader in cataract surgery, we’re eager to accelerate development of this potentially breakthrough accommodating lens technology. By treating cataracts and restoring natural, continuous range of vision, this intraocular lens may be the preferred IOL for cataract surgery patients who desire spectacle independence,” Alcon global business and innovation prez Michael Onuscheck said in a press release.

Last December, Alcon said that it acquired Tear Film Innovations for an undisclosed amount.

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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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Aerie wins FDA nod for second glaucoma drug

Aerie Pharmaceuticals - updated logoAerie Pharmaceuticals (NSDQ:AERI) said this week that the FDA approved the company’s once-daily eye drop Rocklatan for the treatment of elevated intraocular pressure in people with open-angle glaucoma or ocular hypertension.

The Durham, N.C.-based company’s product is a fixed-dose combination of latanoprost and netarsudil – the active ingredient in Aerie’s first drug, Rhopressa.

Get the full story at our sister site, Drug Delivery Business News.

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Ocular Therapeutix posts mixed Q4 results

Ocular Therapeutix logoShares in Ocular Therapeutix (NSDQ:OCUL) fell in premarket activity today after the company posted mixed fourth-quarter results.

The Bedford, Mass.-based company posted a net loss of -$17.4 million, or -42¢ per share, on sales of $504,000 for the three months ended Dec. 31, for sales growth of 3.5% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

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