Presbia reaches ISO medical device quality milestone

Presbia (Nasdaq:LENS) said today that it has successfully completed the ISO 13485:2016 audit with no major findings.

Officials at the Dublin, Ireland–based ophthalmic device company described the audit completion as an essential step toward recertifying under the ISO standard. The company – which has administrative offices and manufacturing in Irvine, Calif. – will receive annual surveillance audits for the next two years.

“We are extremely pleased that we achieved recertification under ISO 13485 during the transitional period, and it further demonstrates our commitment to quality in all aspects of our business,” Bob Lundberg, Presbia‘s SVP of regulatory and quality, said in a news release.

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SightGlass Vision launches trial for pediatric myopia-controlling eyeglasses

SightGlass Vision

Opthalmalogical device maker SightGlass Vision said yesterday that it launched a pivotal clinical trial exploring the use of its novel lenses designed to reduce the rate of progression in children between six and nine years old.

The Palo Alto, Calif.-based company’s Cypress trial is a multicenter, double-blinded, randomized controlled clinical trial that aims to enroll 255 patients across 14 clinical sites in the U.S. and Canada. The primary endpoint of the trial is the progression of myopia over 36 months, the company said.

SightGlass Visions’s lenses are intended to reduce the progression of myopia, something the company said is not provided by current technologies on the market, which only correct for myopia.

“Although some people view myopia as an ordinary, often unavoidable condition, it has been well established that it often progresses rapidly during childhood. This results in the need for stronger prescription glasses and increases the risk of potentially blinding conditions such as glaucoma and retinal detachment in adulthood. We are pleased to be part of the Cypress program to study SightGlass’s novel lenses which could help revolutionize myopia care,” principal investgiator Katie Gilbert-Spear said in a press release.

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Ocular Therapeutix seeks second indication for drug-delivery eye insert

Ocular Therapeutix logoOcular Therapeutix (NSDQ:OCUL) said yesterday that it submitted a supplement NDA to the FDA for its dexamethasone ocular insert, Dextenza.

The Bedford, Mass.-based company requested that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery.

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Results RNA recalls eye drops over undeclared colloidal silver

Results RNA recalled eyedropsResults RNA said this week that it voluntarily recalled its Lubrisine eye drops following an FDA inspection that found the product was not manufactured with sterile practices.

The company also said that the eye drops, which are designed to lubricate dry eyes, were found to contain undeclared colloidal silver. Exposure to colloidal silver over an extended period of time could permanently discolor the conjunctiva, Results RNA warned.

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Ocular Therapeutix lands $25m term loan

Ocular Therapeutix logoOcular Therapeutix (NSDQ:OCUL) said today that it closed a refinancing of its existing debt by landing a $25 million term loan with MidCap Financial and Silicon Valley Bank.

The 5-year term loan facility expanded the company’s prior $18 million credit facility to $25 million. The proceeds from the loan were used to repay the $12.3 million remaining balance under the prior facility and give an additional $12 million in new funds.

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Novartis unit Alcon picks up Tear Film Innovations

Alcon acquires Tear Film InnovationsNovartis (NYSE:NVS) subsidiary Alcon said it acquired Tear Film Innovations for an undisclosed amount.

San Diego-based TFI makes the iLux system, which is designed to treat blocked meibomian glands in eyelids. The company had raised a total of $18 million in two rounds in as many years, split evenly between the two. iLux won 510(k) clearance from the FDA in December 2017 and launched in May of this year, concurrent with an $8.5 million Series B round.

“With the acquisition of Tear Film, we’re excited to bring this latest innovation to treat the millions of people around the world who suffer from dry eye,” Alcon president Andy Pawson said in prepared remarks. “Alcon remains committed to improving the lives of patients around the world through innovative technologies like the iLux device to address significant unmet needs in eye care.”

“Since launching the iLux device earlier this year, we’ve seen an enthusiastic response from eye care professionals who have already begun to incorporate it as an advanced treatment option for patients suffering from meibomian gland dysfunction,” added TFI CEO Rob Thornhill. “Now, as part of Alcon, we’re eager to bring this technology to even more offices throughout the world.”

Alcon said it expects to reveal its plans to expand in other countries in 2019.

In June, Novartis said it’s planning to spin the Alcon unit into a publicly traded company after years of speculation that it wanted to ditch the ill-starred division.

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LumiThera inks Italian Valeda distro deal

LumiThera

LumiThera said today that it inked a deal with ophthalmology distributor Miloftalmica to be the exclusive distributor of the Valeda light delivery system, intended to treat dry age-related macular degeneration, across Italy.

Therapy using the Valeda light delivery system consists of a series of light-based treatments to the retinal cells, which Seattle-based LumiThera claims improves energy production and can be used to address inflammation, ischemia and metabolic dysfunction that contribute to the disease.

“Our new exciting partnership with LumiThera is fully consistent with the strategy and growth objectives of Miloftalmica, combining innovation and excellence in technology. LumiThera’s breakthrough light delivery system is a value added to Miloftalmica’s product portfolio. LumiThera indeed enables us to offer the first approved treatment for people suffering from dry AMD, the leading cause of adult blindness worldwide,” Miloftalmica CEO Andrea Pagani said in a prepared statement.

“The distribution agreement with Miloftalmica allows LumiThera to expand commercialization in Europe and establishes a collaboration with a partner providing complementary diagnostic and imaging technologies to our treatment for dry AMD. Miloftalmica is a leader in providing innovative technologies to the ophthalmologist and we are excited to be working with them to provide our treatment for dry AMD,” LumiThera prez & CEO Clark Tedford said in a press release.

In October, LumiThera said that it inked a distribution deal with Nikon (TYO:7731) subsidiary Optos to distribute its Valeda light delivery system.

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Feds drop insider trading, perjury charges against ex-AMO chief Mazzo

Federal prosecutors this week dropped perjury and insider trading charges against former Advanced Medical Optics CEO James Mazzo related to AMO’s $2.8 billion acquisition by Abbott (NYSE:ABT) in 2009 in light of two hung juries, according to court documents.

Judge Andrew Guilford for the U.S. District Court for the Central District of California ordered a dismissal with prejudice for Mazzo this week, according to court documents.

Mazzo faced charges of tipping close friend and neighbor Doug DeCinces, a former Orioles player, about AMO’s then-pending merger (Abbott subsequently sold the business to Johnson & Johnson (NYSE:JNJ) for $4.33 billion last year). DeCinces allegedly passed that information on to former teammate Eddie Murray, who later agreed to settle his case for $358,000 but admitted no wrongdoing; DeCinces agreed in 2011 to pony up $2.5 million (but admitted no guilt) to settle similar charges leveled by the SEC.

Last month, Mazzo agreed to pay $1.5 million but admitted no wrongdoing in the settlement, the SEC said.

A California federal judge in May 2017 declared a mistrial in Mazzo’s first trial, after a jury deadlocked over the charges against him. That jury also convicted DeCinces and a business associate on charges of tender offer fraud, despite deadlocking on other charges against DeCinces and all of the charges against Mazzo.

Mazzo, now global ophthalmology president at Carl Zeiss Meditec (ETR:AFX) after a 3-year run as president and CEO at AcuFocus, had argued that there is “no evidence” of him “lying, cheating, or hiding anything.” In February a new jury once again hit deadlock in the second trial, prompting another mistrial; a third trial is now off the table.

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Alimera Sciences wins Health Canada nod for diabetic macular edema implant

Alimera Sciences updated logoAlimera Sciences (NSDQ:ALIM) said last month that it won approval in Canada for its intravitreal implant designed to treat diabetic macular edema.

The Iluvien device is a sustained release implant that delivers fluocinolone acetonide and is indicated to treat diabetic macular edema in people who have been previously given corticosteroids and did not have a clinically significant rise in intraocular pressure.

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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.

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