6/26/2017
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`Novel neurostimulator device uses nasal cavities to stimulate tears | OphthalmologyTimes
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`Important Safety Information
`In clinical trials, the most common adverse
`reactions reported in 5­25% of patients were
`instillation site irritation, dysgeusia and
`reduced visual acuity. Other adverse
`reactions reported in 1% to 5% of the patients
`were blurred vision, conjunctival hyperemia,
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`OphthalmologyTimes
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`Ophthalmology
`
`Arturo Chayet
`
`Novel neurostimulator device uses nasal
`cavities to stimulate tears
`Intranasal electrical stimulation offers new pathway to upregulate
`body’s tearing system
`
`March 15, 2017
`
`By Michelle Dalton
`
`Editor’s note: Since the time of these presentations, Allergan submitted a de novo
`application for the Oculeve Intranasal Tear Neurostimulator device. According to the
`FDA, this process provides a pathway for medical devices for which general and/or
`special controls provide a reasonable assurance of safety and effectiveness, but for
`which there is no legally marketed predicate device.
`
`Chronic dry eye disease (DED) affects more than 25 million people and to date the only
`pharmacologic therapies are topical or involve punctal plugs.
`
`Results from two studies wth a neurostimulator indicate there may be a new pathway to
`upregulate the body’s tear system.
`
`The device (Oculeve Intranasal Tear Neurostimulator, Allergan) comprises a disposable tip
`with hydrogel that tops a durable, rechargable stimulator unit, said John Berdahl, MD,
`Vance Thompson Vision, Sioux Falls, SD. Five levels of patient­adjusted stimulation are
`part of the device as well.
`
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`POLL
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`MYLAN - EXHIBIT 1051
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc. - IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
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`

`

`6/26/2017
`
`CAREERS
`
`Important Safety Information
`In clinical trials, the most common adverse
`reactions reported in 5­25% of patients were
`instillation site irritation, dysgeusia and
`reduced visual acuity. Other adverse
`reactions reported in 1% to 5% of the patients
`were blurred vision, conjunctival hyperemia,
`
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`anti-VEGF injection frequency for AMD
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`Continued interval therapy of every 4
`weeks or 8 weeks
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`Treat­and­extend intervals
`
`As­needed
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`Other
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`ANSWER
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`VIEW RESULTS
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`Novel neurostimulator device uses nasal cavities to stimulate tears | OphthalmologyTimes
`The device was developed at Stanford University by Michael Ackermann, PhD; James
`PUBLICATIONS
`BUSINESS
`EDUCATION
`Loudin, PhD; and Daniel Palanker, PhD.
` 
`
`New evidence
`
`Stephen C. Pflugfelder, MD, chair and professor of ophthalmology, Baylor College of
`Medicine, Houston, said clinicians now know tear secretion is regulated by the lacrimal
`functional unit, and that the nasal cavities play a role.
`
`“Schirmer with nasal stimulation with a cotton­tip applicator is recognized to induce reflex
`tearing,” Dr. Pflugfelder said, “Nasal anesthesia decreases tear production by 34% in
`normal subjects.”
`
`Goblet cells secrete mucin in response to neural stimulation, he added.
`
`Several publications confirm dry eye may disrupt neural signaling of tear secretion by
`decreased corneal sensitivity, anticholingergic medications, autoantibodies to acetylcholine
`receptors, or inflammatory cytokines, Dr. Pflugfelder said.
`
`Pathway advantage
`
`1
`
`2
`
`TAGS
`
`Arturo Chayet
`
`Cornea
`
`dry eye
`
`dry eye disease
`
`John Berdahl, MD
`
`Modern Medicine Cases
`
`Modern Medicine Feature Articles
`
`Modern Medicine News
`
`nasal nerve stimulator
`
`neurostimulation
`
`Stephen C. Pflugfelder, MD
`
`Technology­Ophthalmology
`
`Ophthalmology
`
`Michelle Dalton
`
`We recommend
`
`Dry eye has new point of care
`Cheryl Guttman Krader et al., Opthamology Times,
`2013
`
`Dry eye has new point of care
`By Cheryl Guttman Krader, Opthamology Times, 2013
`
`Pain without stain poses diagnostic and therapeutic
`dilemma
`Cheryl Guttman Krader et al., Opthamology Times,
`2015
`
`Intranasal neurostimulation increases tear production,
`improves dry eye signs/symptoms
`Cheryl Guttman Krader et al., Opthamology Times,
`2017
`
`6 things you need to know: Genetic markers for
`glaucoma identified
`Colleen E. McCarthy et al., Optometry Times, 2016
`
`MORE
`
`Hope for 'Suicide Headache' 
`Caroline Cassels et al., Medscape, 2015
`
`Impact of Intranasal Neurostimulation on Conjunctival
`Goblet Cell Degranulation
`PracticeUpdate, 2017
`
`Dry Eye Syndrome: Diagnostic and Treatment Tips
`Pippa B. Wysong et al., Medscape, 2016
`
`New Therapies Strive to Douse Dry Eye Syndrome
`Nancy A. Melville et al., Medscape, 2014
`
`Air Pollution Increases Dry Eye Syndrome
`Alice Goodman et al., Medscape, 2013
`
`http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/news/novel-neurostimulator-device-uses-nasal-cavities-stimulate-tears
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`2/3
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`6/26/2017
`
`Novel neurostimulator device uses nasal cavities to stimulate tears | OphthalmologyTimes
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`Important Safety Information
`In clinical trials, the most common adverse
`reactions reported in 5­25% of patients were
`instillation site irritation, dysgeusia and
`reduced visual acuity. Other adverse
`reactions reported in 1% to 5% of the patients
`were blurred vision, conjunctival hyperemia,
`
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