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.




Novartis completes spinout of Alcon eye biz

Novartis AlconNovartis (NYSE:NVS) closed the spinout of its Alcon vision care business, setting the stage for its shares to begin trading today in Switzerland and New York.

The spinout, announced last June, saw each Novartis shareholder receive a single ALC share for every five NVS shares as of the close of business April 1, Novartis said last month.

“For more than 70 years, Alcon has been dedicated to helping people see brilliantly and now, as an independent company, we are pursuing even more opportunities to further that mission,” CEO David Endicott said in prepared remarks. “We are poised to achieve sustainable growth and create long-term shareholder value as a standalone company. We have a long history of industry firsts and, as a nimble medical device company, we are sharply focused on providing innovative products that meet the needs of our customers, patients and consumers.”

Alcon’s share of the roughly $23 billion vision market was 30.9% last year at $7.1 billion, with surgical revenues up 7% to $4.0 billion and vision care sales up 3% to $3.1 billion compared with 2017, the Geneva-based company said.

Novartis bought Alcon in 2010 after a years-long courtship.

Report: J&J plans €100m expansion in Ireland, to add 100 jobs

Johnson & Johnson VisionJohnson & Johnson (NYSE:JNJ) is reportedly planning to expand its vision business in Ireland with a €100 million project that’s slated to add 100 jobs to the local economy.

The plant in Limerick is expected to bring 100 permanent jobs on top of 200 temporary construction jobs, Silicon Republic reported.

“We believe that the new manufacturing roles being introduced in Limerick in 2019 will be foundational in helping us bring new, innovative contact lens products to our patients and customers around the world at an industry-leading pace,” J&J Vision Care plant leader John Lynch said.

J&J Vision employs roughly 1,000 people in Limerick, according to the website.

Last week Edwards Lifesciences (NYSE:EW) said it’s looking to open a new facility in Limerick that could bring in up to 600 new jobs for the region.

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Novartis plans Alcon spinout for early April

Novartis AlconNovartis (NYSE:NVS) said today that it’s planning to list the shares of its Alcon vision care business April 9 in Switzerland and New York.

Terms for the spinout, announced last June, call for each Novartis shareholder to receive a single ALC share for every five NVS shares at the close of business April 8.

The Swiss SIX exchange and the New York Stock Exchange have each approved the listing, Novartis said.

“Alcon has secured debt financing of $3.5 billion through a group of banks. The Alcon credit rating will be investment-grade following the spin-off. Moody’s Investor Service and S&P Global Ratings have rated Alcon at Baa2 and BBB, respectively, with a stable outlook,” Novartis said.

Bank of America Merrill Lynch and UBS are advisors on the deal, the company said. Novartis bought Alcon in 2010 after a years-long courtship.

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FDA slaps Class 1 designation on corneal implant recall

FDA has upgraded a recall of the Raindrop corneal inlay to Class I, the most serious designation.

Developed by the now-defunct ReVision Optics, the inlay was designed to treat presbyopia. But 75% of patients in a post-approval surveillance study developed corneal hazing. ReVision closed its doors last year; RVO 2.0, doing business as Optics Medical, now owns the Raindrop device and initiated the recall in November, advising customers not to implant the inlay devices. Raindrop is banned from distribution in the U.S., according to FDA.

Lake Forest, Calif.-based ReVision won pre-market approval from the FDA in June 2016 for the Raindrop inlay to treat presbyopia. The device is a microscopic hydrogel inlay placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to reshape the anterior curvature of the cornea.

The recall covers 2,869 devices distributed between August 2016 and March 2018. FDA issued a safety communication in October, citing a five-year, 150-patient post-approval study. Interim data showed a 42% rate of central corneal haze (63/150), a 75% rate of any corneal haze (113/150) and a 23.3% rate of device removal to date (35/150); of those, some 31% (11/35) had their Raindrop implant removed due to corneal haze, according to the agency.

FDA had initially cleared Raindrop based on two-year clinical data showing a 16.1% rate of central corneal haze (60 of 373 patients), a 1.1% rate of patients with two or more lines of loss in vision (4/373) and a device removal rate of 6.4% (24/373); some 29% of those removals were due to corneal haze (7/24), the agency said.

FDA said it began working with Optics Medical last year to remove the product from the market.


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What should the Mann Foundation do next?

Brad Perriello, executive editor – Medical at WTWH Media (left), interviews Dr. Robert Greenberg of the Alfred Mann Foundation at DeviceTalks West in Costa Mesa, Calif. [Image by WTWH videographer Graham Smith]

Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December.

The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation for the first time is also inviting outside companies to use its resources.

Founded in 1985, the Valencia-Calif.–based foundation has launched several innovative companies, including Second Sight Medical Products (NSDQ:EYES), which makes devices for the visually impaired; cochlear implant manufacturer Advanced Bionics, now a subsidiary of Sonova Holding AG (SIX:SOON); and MiniMed, developer of a hybrid closed-loop insulin delivery system, now part of Medtronic (NYSE:MDT).

“It was essentially an incubator before the term ‘incubator’ even existed,” said Dr. Robert Greenberg, who took over as executive chairman in June 2018 after serving as non-executive chairman since 2004. (John Petrovich leads AMF as its CEO.)

Get the full story on our sister site, Medical Design & Outsourcing.

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Notal Vision snags breakthrough designation for home OCT system

Ophthalmic diagnostic services company Notal Vision said it has won breakthrough device designation for its artificial-intelligence-aided macular degeneration diagnostic device.

Privately-held Notal (Manassas, Va.) said its home-based optical coherence tomography (OCT) system was designed to automatically identify intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD). The Notal Home OCT device is intended for testing at home between regularly scheduled clinic assessments and not intended to replace standard-of-care regularly scheduled examinations and clinical testing by an ophthalmic retinal specialist, the company said.

Get the full story on our sister site, Medical Design & Outsourcing.

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Pixium Vision’s novel Prima chip helps patients see the light

Pixium Vision said today that its Prima miniature wireless photovoltaic sub-retinal implant has been activated in the first five patients.

The patients all have severe vision loss from atrophic dry age-related macular degeneration. They are enrolled in a three-year clinical study in France to evaluate the safety and function of the Prima chip in eliciting visual light perception, the company said in a statement. All five reported seeing useful light patterns in areas where they had had no remaining light perception. The current study patients will be taught how to interpret their new artificial central macular perception.

Get the full story on our sister site, Medical Design & Outsourcing.

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