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FDA Advises Caution on Contacts for Kids

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Close monitoring is necessary, says the agency.

The FDA is reminding parents that “contact lenses are medical devices, not cosmetics,” and urging that children who wear them be closely monitored by eyecare professionals. “Like any medical device, contact lenses should be used only if they can be used safely and responsibly,” says an agency optometrist. Contact lenses account for about one-fourth of the more than 70,000 childhood injuries and complications from medical devices treated each year in U.S. emergency departments, according to a 2010 study in the journal Pediatrics.

Read more at News Journal

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AOA Approved for Group Purchasing of Lenses, Frames, Contacts

The U.S. Department of Justice gave its OK.

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The U.S. Department of Justice has given the American Optometric Association the nod to expand its group purchasing activities to include lenses, frames and contacts.

The association and its subsidiary AOAExcel GPO LLC had asked the department for a business review letter on the matter. Law360 explains that such a document can provide “proactive assurances of non-enforcement.”

The department explained in the Jan. 15 letter that it “presently does not intend to challenge the GPO’s expansion to include optometric products.” It noted, however, that it “reserves the right to challenge the GPO in the future if the GPO’s operations are determined to be anticompetitive in purpose or effect.”

Up until now, AOA’s group purchasing organization has only offered non-optometric products, such as professional liability insurance, credit card processing, life insurance, general office supplies, general medical supplies and equipment. It uses Intalere, a third-party healthcare group purchasing organization, as its agent to negotiate discounts on products and services.

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As of February 2019, 1,011 association member optometric practices had signed up to participate, and 251 practices had made at least one purchase.

The Department of Justice wrote: “Based on our investigation and your representations described above regarding the GPO [group purchasing organization] and its proposed expansion to include optometric products, the GPO expansion is unlikely to produce anticompetitive effects.”

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Biotech Firm Raises $30M for Eye Disease Therapies

It’s focusing on retinal and other ophthalmic maladies.

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PARIS & FORT WORTH, TX — Eyevensys, a biotechnology company developing non-viral gene therapies for retinal and other ophthalmic diseases, has completed a $30 million funding round.

The company will use the funds to continue development of its clinical lead candidate — known as EYS606 — for the treatment of chronic non-infectious uveitis, including the launch of its Electro Study, according to a press release. This Phase 2 trial, to be conducted in the U.S., will evaluate the safety and efficacy of the candidate in patients with active forms of all anatomic uveitis subtypes.

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The funding will also advance the preclinical development of the firm’s other therapeutic proteins targeting ophthalmic diseases with unaddressed medical needs, such as retinitis pigmentosa and age-related macular degeneration. A product candidate known as EYS606 is currently in a phase I/II clinical trial in the European Union and has been granted an Orphan drug designation by the European Medicines Agency for the treatment of non-infectious uveitis.

The new Series B financing round was led by Boehringer Ingelheim Venture Fund and included participation from existing investors Pontifax, Bpifrance, CapDecisif, and Inserm Transfert, as well as new investors, the Global Health Sciences Fund (Quark Venture LP and GF Securities) and Pureos Bioventures.

In conjunction with the financing, Eyevensys has added members to its board of directors. Neena Kadaba, PhD, director of science at Quark Venture LP, joined the board, as did Dominik Escher, PhD, managing partner at Pureos Bioventures and former founder and CEO of ESBATech, an ophthalmology biotech company acquired by Alcon in 2009.

Eyevensys has also recently opened a wholly owned U.S. subsidiary in Fort Worth, TX. All U.S. operations will be managed from this location, though the Eyevensys headquarters will remain in Paris.

Dr. Patricia Zilliox, Chief Executive Officer, said, “We are thrilled to have completed this Series B funding round with the strong support from both existing and new investors for the company. This funding will assist the further development of our technology and position Eyevensys as an innovator in the field of ophthalmology.”

She continued: “As we launch the Electro Study, our first U.S. clinical trial, Eyevensys will also have an opportunity to connect with ophthalmology opinion leaders in the U.S. to gain further exposure for our groundbreaking technology platform. This will also move the company one step closer to providing a more effective and convenient treatment approach to ease the burden of managing patients with chronic ocular conditions.”

As for technical specifics, the company states:

The Eyevensys technology is a non-viral gene therapy ocular drug delivery platform that uses an Electrotransfection System to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle. This turns the eye into a biofactory, allowing the ciliary muscle to express and secrete the therapeutic protein to the back of the eye at therapeutic levels for a duration of greater than 6 months.

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Smart Glasses ‘Breakthrough’ Likely Not Far Off, Zuckerberg Says

New products ‘will redefine our relationship with technology.’

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Facebook CEO Mark Zuckerberg says major developments in augmented reality are probable in the coming decade, CNBC reports.

He offered his thoughts in a Facebook post last week, writing, “The technology platform of the 2010s was the mobile phone. While I expect phones to still be our primary devices through most of this decade, at some point in the 2020s, we will get breakthrough augmented reality glasses that will redefine our relationship with technology.”

CNBC decribes augmented reality as “technology that lets users place digital objects on top of the real world.”

Zuckerberg acknowledged that some augmented-reality products to this point have felt “clunky.” But he said new products “will be the most human and social technology platforms anyone has built yet.”

He said augmented reality could improve many areas of life, including careers: “Imagine if you could live anywhere you chose and access any job anywhere else. If we deliver on what we’re building, this should be much closer to reality by 2030.”

In September, Facebook was reported to be working with Luxottica to develop a pair of smart glasses. The project was reportedly code-named Orion.

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The glasses would be intended to disrupt the smartphone market. Zacks reported at the time that the idea was to “allow users of the smart glasses to take calls, livestream on social media and many other such features that are intended to replace smartphones.”

With the smart glasses project, Facebook was apparently “raising its efforts to withstand the intense competition in the next-generation glasses space from Snap, Google, Microsoft and Apple,” Zacks said at the time.

Read more at the CNBC

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