Clinical Pearls for Management of Dry Eye Disease 1 hour · Clinical Pearls for the Managemnet of...

Clinical Pearls for the Managemnet of Dry Eye Disease

February 14, 20/20

Greg A. Caldwell, OD, FAAO [email protected] 814-931-2030 cell 1

Clinical Pearls in the Management of

Dry Eye Disease

Greg Caldwell OD, FAAOOptometric Education Consultants

Mid-Winter Getaway February 14, 20/20

Disclosure Statement(next slide)

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Disclosures- Greg Caldwell, OD, FAAO

$ Will mention many products, instruments and companies during our discussion

¬ I don’t have any financial interest in any of these products, instruments or companies

$ Pennsylvania Optometric Association –President 2010

2 POA Board of Directors 2006-2011

$ American Optometric Association, Trustee 2013-2016

$ I never used or will use my volunteer positions to further my lecturing career

$ Lectured for: Aerie, Alcon, Allergan, BioTissue, Maculogix, OptoVue

$ Advisory Board: Allergan, Maculogix, Sight Sciences, Sun, Takeda

$ Envolve: PA Medical Director, Credential Committee

$ Optometric Education Consultants- Scottsdale, St. Paul, Quebec City, Nashville, and Orlando/Disney OCT Users meeting; Owner

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Financial Obligations

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Course Description and Learning Objectives

$Dry eye is a common yet under diagnosed cause of ocular morbidity such as decreased vision and ocular discomfort. This course will view the modern management of dry eye disease including pharmaceuticals, nutraceuticals, and devices. This case based presentation will aid in the diagnosis, treatment, and guidance around pitfalls.

$Review aqueous deficient and evaporative dry eye$Review the diagnostic techniques to help diagnose aqueous deficient versus evaporative dry eye$Discuss current and modern treatment of dry eye disease$Discuss current pharmaceutical and nutraceutical therapies$Review the current devices available for the treatment of dry eye disease

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How Many People With

$Diabetes$Thyroid$Glaucoma$Dry Eye

¬ 30 million

5

Experts Gather for Recommendations and Algorithms

$Corneal, External Disease, and Refractive Society¬ Dysfunctional Tear Syndrome (DTS)

$Tear Film & Ocular Surface Society ¬ Dry Eye Workshop II (TFOS DEWS II)

$Delphi Panel International Task Force¬ Delphi Panel

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February 14, 20/20


7 8

9 10

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Vital Dyes $ Fluorescein

¬ Detects disruption of intercellular junctions

¬ Positive (stain)-pooling

¬ Negative (stain)-high or elevated areas

$ Rose bengal and Lissamine green ¬ Stains devitalized cells and cells that have lost

normal mucin surface

¬ Detects abnormal epithelial cells

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February 14, 20/20


Why are Conjunctival Staining and SPK Often Missed or Under Scored?

Wratten Filter

13 14

Aqueous Deficient vs Evaporative

$What’s the common denominator?¬ Eyes burn/discomfort/pain¬ pH

$What’s the next question?¬ When is it worse?

2 AM/PM

$AM- bacteria/parasite related$PM- aqueous deficient

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Let’s Focus on Evaporative ---------------------------------------------------------------------------------------

48 year old manOU red, gritty, sandy and dry feeling

Va 20 20 20cc 20

Current CorrectionR -2.00 sphereL -3.00 sphere

EOMS: full, unrestricted PERRL (-)APDCT: ortho D/N CF: full by FC OU

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$Diagnosis¬ Rosacea

$What findings support your diagnosis?¬ Telangiectasias¬ Erythema of the cheeks,

forehead and nose

¬ Rhinophyma2 Indicates chronic

$Let us get a closer look

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A Closer Look

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February 14, 20/20


Meibomian Gland DysfunctionExacerbated by Rosacea

Evaporative

$Treatment?¬Warm compresses¬Lid hygiene¬Artificial tears¬Omega 3 fatty acid

2 EPA and DHA total 1500 mg (1000 mg minimum) ¬Dermatological consult (Acne Rosacea)¬Oral antibiotics…???

2 Which one and why??

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Minocycline

Leukotrienes

Arachidonic Acid

Staph Aureus

Staph EpidermidisLipase

Meibomian Gland Secretions(Lipid)

Prostaglandins

Thromboxines

Marginal Foam(Soap)

TurbidInspissated MG

How About Steroids?

Phospholipids

Tetracycline Analog

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Clinical PearlTreatment Failure

$ If you continue to think of doxycycline and minocycline as antibiotics, treatment failure will be the result

$From this point on consider them a steroid

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Minocycline / Doxycycline

$Drug of choice for MGD, marginal inflammatory blepharitis (posterior blepharitis)

$AB, anti-inflammatory and anti-collagenase$Inhibits lipase enzyme$No renal adjustment$50-100 mg qd-bid 2-12 weeks (pulse)

¬Lower maintenance dose

$20 mg Periostat (Doxycycline)¬Helpful in those with stomach or GI sensitivity

¬Excellent for those requiring long maintenance dose

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Hyclate vs Monohydrate

$ I get calls from the pharmacist¬ Doxycycline

2 Doryx

– Enteric coated hyclate pellet)

2 Adoxa

– Monohydrate

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My Paradigm for Minocycline / Doxycycline

$Status of MG

¬Inspissated

¬Turbid

¬Clear

$ Minocycline / Doxycycline Paradigm

¬Maximum dosage for 2-12 weeks (pulse)2 100 mg BID, QD

¬50-100mg qd while turbid¬20 mg longer treatments

2 Periostat (Doxycycline)

¬20 mg if maintenance dose needed

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February 14, 20/20


What is an Inspissated MG?

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I Can’t Believe It’s Not Butter!® Squeeze

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2016 Treatment Current Precautions and Innovative Changes?

$Warm Compresses$Lid Scrubs$Artificial Tears, Systane Balance$Omega 3 (1500 EPA and DHA)

$Mino 100 mg PO 6 weeks, 50 mg 3 months, 20 mg maintenance (Doxy)

$Steroids, Tobradex qid (5 weeks with taper)¬ Moderately red and thickened lid margins¬ Marginal infiltrates

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Precautions with Oral Tetracycline Analogs

$Tetracycline analogs¬ Doxycycline

¬ Minocycline

$Enhanced photosensitivity$Avoid in children and pregnancy (Category D)

$Enhances the effects of ¬ Coumadin¬ Digoxin

$ Idiopathic intracranial hypertension¬ Pseudotumor cerebri

$Hyperpigmentation

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Benign intracranial hypertension“It’s not rare if it’s in your chair”

8-19-2010

8-31-2010(12 days)

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February 14, 20/20


9-13-201025 days

10-6-201048 days

8-19-2010

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Minocycline Optic Nerve Edema

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Minocycline Optic Nerve Edema

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OMG!

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6 Month Later

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1 Year Later

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February 14, 20/20


Innovations

Dry Eye Disease

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Meibomian Gland Imaging Systems

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OTC25%

Rx71%

Procedures4%

Procedures Currently Represent 4% of all US Dry Eye Revenue

$Revenue for Dry Eye Products by Segment¬ Procedures AM, plugs, Lipiflow, Miboflo

Market Scope 2017 Dry Eye Products Report

“Newer dry eye procedures offer the most significant potential for market growth.”

– Market Scope

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Heat to the MG

What has changed?What is new?

Is it better you decide

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Bruder Moist Heat Eye Compress

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Bruder Moist Heat Eye Compress

$ Moist heat treatment ¬ Stabilize the tear film, improve oil gland function, slow tear evaporation

$ Ready in seconds, easy to use¬ Patient compliance increases

$ Patented MediBeads¬ Self-hydrating (no need to add water)

¬ Anti-bacterial and non-allergenic

¬ Washable and reusable

$ Safe for frequent use ¬ Microwave for 20-25 seconds

¬ Apply for 10 minutes

$ Unique pod design provides improved fit and performance

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February 14, 20/20


Dry Eye Relief and Daily Eyelid Hygiene

Micro-fine sheets are designed to cleanse the eyelids

Bruder Cold Therapy Eye Compress

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Mibo Heating Pad

$5 settings$Aromatherapy

¬ Lavender

$USB powered

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Mibo Thermoflo$ Ultrasound gel, heat, skin$ Comfortable treatment, no pressure$ No disposables (ROI for the practice)$ Technician driven eliminating the need to burn the doctors chair

time$ Dry eye maintenance$ Pricing for patients is more affordable than other options

making the treatment more easily accepted by patients

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Personalized Open Eye ExperienceFor those w ho su ffer from dry eye d isease , TearCare® is the m ost personalized procedure that o ffers a savvy approach

Natural-blink design

Ultra-precise meibomian gland clearance

Patented smart system

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Fo r th e a p p lica tio n o f lo ca lize d h e a t w h e n th e curre n t m e d ica l co m m un ity re co m m e n d s th e a p p lica tio n o f a w a rm co m p re ss to th e e ye lid s. Such a p p lica tio n s w o u ld in c lud e M e ib o m ia n G la n d D ysfun ctio n (M G D ), D ry Eye , o r B le p h a ritis

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Pharma Update

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February 14, 20/20


Nuzyra™(omadacycline)

$Tetracycline antibiotic$Approved 2018$Approved for PO/IV treatment of patients

¬ Bacterial skin infections¬ Community-acquired bacterial pneumonia

$ADRs: ¬ Nausea, vomiting, diarrhea, constipation, insomnia¬ Chelation issues JUST like other tetracyclines!

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Seysara™ (sarecycline)

$Tetracycline drug$Approved 2018$ Indicated for the treatment of inflammatory acne in non-nodular, moderate

to severe acne vulgaris$Potential for MGD treatment

$Can be taken WITH or WITHOUT food!

$ADRs: nausea

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Xerava™ (eravacycyline)

$Tetracycline antibiotic$Approved 2018

$ Indicated for the treatment of intra-abdominal infections in adults$ IV ONLY

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Few Pearls on Dry Eye

$30 million or 10% of adults have dry eye¬ 16 million diagnosed and treated¬ 2 million are on a Rx for dry eye disease (Xiidra, Cequa, Restasisi)

$Reported that the patient sees 3 different doctors before dry eye disease$Most have used about 3 different tears

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Xiidra™ (lifitegrast) 5%

$Company: Shire, Takeda, Novartis ¬ Approved July 2016

¬Specific treatments/indication: dry eye disease2 Signs and symptoms of dry eye

¬Dosage: one drop twice daily in each eye, 12 hours apart2Dysgeusia, site irritation, blurred vision

¬Relief as soon as 2 weeks with symptoms2 Eye Dryness Score

¬Signs improve as soon as 12 weeks2 Inferior cornea staining

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Xiidra™ (lifitegrast) 5%

$Mechanism of Action¬ Lymphocyte function-associated antigen-1 antagonist

2 LFA-1 is found on the T-cell

2 Blocks ICAM-1/LFA-1 interaction– Intercellular adhesion molecule-1

2 ICAM is overexpressed in dry eye– Cornea, conjunctiva, lacrimal gland

¬ Anti-inflammatory by inhibiting

2 T-cell activation2 T-cell migration2 Cytokine Release

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February 14, 20/20


Xiidra™ (lifitegrast) 5% $Xiidra™ or Restasis™? Or BOTH?

¬Yes, based on Mechanism of Action (MOA)¬Need more longitudinal data from post-marketing surveillance to

determine:2 Efficacy and toxicity as an individual drug2As well as efficacy and toxicity as compared to Restasis

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Xiidra™ - What I Have Learned

$ Only pharmaceutical indicated for signs and symptoms of dry eye disease$ Works within:

¬ 2 weeks for moderate DED

¬ 6 weeks for mild

¬ Cornea staining takes 12 weeks

$ Use it as a diagnostic $ 30 million USA adults with DED$ BID means 12 hours apart$ Get in front of the dysgeusia $ Works great for GPC and SAC. Look for post IOL patient

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CequaTM (cyclosporine ophthalmic solution) 0.09%

$Sun Pharmaceuticals¬ Approved August 2018

$Dosed BID$Single-use vials

$ “New Nanomicellar Ophthalmic Solution for Treatment of Keratoconjunctivitis Sicca”¬ Formulation technology uses micelles

$ Gelatinous aggregates of amphipathic molecules¬ Hydrophobic and hydrophilic molecules

¬ Ease of entry into conjunctiva and cornea2 High delivery of cyclosporine A (CsA)

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Cequa™ (cyclosporine ophthalmic solution) 0.09%Indication and Important Safety Information

Indication:A calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca

Warnings and Precautions:Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces. Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution

Adverse Reactions:The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%)

Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection

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Cequa™ Formulation$ Novel, aqueous, nanomicellar formulation of cyclosporine A 0.09%1–4

$ Unpreserved, isotonic, neutral pH fluid that is supplied in unit dose vials

$ Well tolerated in a 12-week phase 2b/3 study5

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1. Cholkar K et al. Recent Pat Nanomed. 2012;2:82-95 2. Mandal A et al. J Control Release. 2017;248:96-116. 3. Vaishya RD et al. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2014;6:422-437. 4. Cholkar K et al. Transl Vis Sci Technol. 2015;4:1-16 5. Tauber J, et al. ASCRS 2017 Paper presentation.

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Primary Endpoints

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Note: Data shown for the intent-to-treat population (subjects randomized, excluding 1 subject who was assigned to OTX-101 but not treated); missing data on day 84 were imputed by baseline values carried forward.

p <0.0001

LS, least squares; SE, standard error.OTX-101-2016-001 study report; data on file.

Schirmer's test Total conjunctival staining score Central corneal staining score

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February 14, 20/20


SteroidsKetones versus Esters

$Prednisolone acetate molecule modified to undergo predictable degradation to inactive metabolites by local esterases

$Corticosteroids, C-20 ketone replaced with a C-20 ester$C-20 ester steroids are associated with a lower incidence of IOP elevations vs.

C-20 ketone steroids ¬ IOP and cataracts

$Retrometabolic drug design of loteprednol aims to improve safety while maintaining efficacy

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Loteprednol Etabonate ProductsEster Steroids

$Lotemax suspension 0.5%$Alrex suspension 0.2%$Lotemax gel 0.5%

$Lotemax SM gel 0.38%$ Inveltys suspension 1.0%$KPI-121 loteprednol etabonate suspension 0.25%

814-931-2030

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Lotemax SM (loteprednol etabonate) 0.38%

$ Indicated for the treatment of post-operative inflammation and pain following ocular surgery

$SubMicron - Particle size reduced to facilitate ocular penetration¬ Allowing for a decrease in drug concentration and dosing frequency (TID)¬ Increase intraocular penetration¬ Median particle diameter size reduced 5 to 12.5-fold:

2 LE gel 0.38% = 0.4-0.6 µm2 Lotemax gel 0.5% = 3-5 µm

¬ Potential for a ~10-fold increase in rate of drug dissolution2 Based on a 10-fold increase in relative surface area with smaller particles

814-931-2030

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$ Increased concentrations demonstrated in ocular tissues ¬ Cornea and aqueous humor ¬ Following single topical ocular instillation of Lotemax SM 0.38% vs Lotemax gel 0.5% in

rabbits

$ Compared to Lotemax Gel 0.5%¬ Single topical instillation of Lotemax SM 0.38% were greater in the aqueous humor and

cornea¬ Concentrations in the conjunctiva remain the highest out of the ocular tissues, with ample

drug to mediate anti-inflammatory effects at the ocular surface

$ Formulation advancement while maintaining a low BAK¬ Lowest concentration of BAK, 0.003% among the commercially available corticosteroid

ocular drops2 Inveltys is 0.01%


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$Submicron formulation is designed to reduce the Lotemax Gel drug concentration 0.38% vs. 0.5%)

$ Dosing frequency TID vs. QID$Formulation builds on the heritage and advantages of Lotemax gel 0.5%:

$ Retrometabolically designed corticosteroid¬ Retains potent anti-inflammatory activity

¬ Minimal potential for class Aes

$Mucoadhesive, non-settling, shear-thinning gel¬ A gel in the bottle; transitions to a liquid upon instillation

¬ Becomes mucoadhesive liquid on dilution with tears¬ No need to shake - uniform dosing¬ Non-blurring


814-931-2030

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Inveltys ™ - loteprednol etabonate suspension 1.0%

$ Kala (ka-la) Pharmaceuticals $ August 2018$ Now in distribution centers and pharmacies $ Nanoparticle-based Mucus Penetrating Particles (MPP)

¬ “Amplified Technology”

¬ MOD

¬ Allows drug to penetrate through tear mucins

2 Increased penetration into tissues, 3-fold to other loteprednol

$ 1.0% post-operative inflammation and pain after ocular surgery¬ Dosage BID

2 First ocular corticosteroid to be BID

814-931-2030

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February 14, 20/20


KPI-121 loteprednol etabonate suspension 0.25%

Stay Tuned$ Kala (ka-la) Pharmaceuticals $ First product indicated for the temporary relief of signs and symptoms of dry eye disease $ Phase 2 and Phase 3 efficacy and safety trials

¬ STRIDE- Short Term Relief in Dry Eye

2 Over 2000 patients with dry eye disease

$ PDUFA date: August 15, 2019¬ Recruiting more people¬ Strict inclusion and exclusion criteria

814-931-2030

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Systane Complete$ The core SYSTANE® technology includes HP-Guar (hydroxypropyl-guar)

¬ Polymer that becomes a gel on instillation, the lubricant propylene glycol as the active ingredient, and the inactive ingredients phospholipid DMPG and mineral oil to help deliver the active ingredient.

$ Lipid nanodroplet technology that results in better coverage of the ocular surface vs. SYSTANE® BALANCE Lubricant Eye Drops

$ Designed to minimize blur upon instillation due to its nanodroplet formulation

$ Completely free of benzalkonium chloride$ Contains 3 times the concentration of HP-Guar per unit volume,

compared to SYSTANE® BALANCE Lubricant Eye Drops¬ This permits greater cross-linking and persistence of the protective elastic matrix, resulting in

better retention of the propylene glycol lubricant and protection against tear evaporation.

$ Nanodroplet technology provides better coverage of the ocular surface, fast-acting hydration, and long-lasting relief compared to SYSTANE® BALANCE Lubricant Eye Drops.

$ Supports all layers of the tear film and helps protect against tear film evaporation

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Hygiene Solutions



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Hypochlorous Acid$ Natural antibacterial agent

¬ Found in white blood cells¬ Different mechanism of action of antibiotics

2 Oxidant; bactericidal

$Skin microbiome contributes to infection, blepharitis, and MGD¬ Staphylococcus aureus, Staphylococcus

epidermidis, Corynebacterium, and Propionibacterium acnes

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(hypochlorous acid .01%)HyClear™ is PureHyClear is a non-cytotoxic, non-irritating solution recommended for daily use

HyClear™ is StableHyClear provides up to an 18 month shelf life after openingHyClear™ is EffectiveHyClear kills the majority of ocular pathogens in seconds

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February 14, 20/20


Nutraceutical Therapies



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Nutraceutical Therapies in Dry Eye

$Looking for anti-inflammatory fatty acids¬ Dry eye efficacy

$”Fish oil” will provide nice hair, nails, and skin$Gamma-Linolenic Acid GLA

¬ Specific action that ”fish oil” omegas lack¬ 7 randomized controlled trials for dry eye

2 Aqueous-deficient (Barabino S et al. Cornea 22: 97–101, 2003.)2 PRK (Macri A et al. Graefes Arch Clin Exp Ophthalmol 241:561-6, 2003.)2 Sjögren's (Aragona P, et al. Ophthalmol Vis Sci 46:4474-9, 2005.)2 Contact lens (Kokke KH et al. Contact Lens Ant. Eye 31:141-6, 2008.) 2 MGD (Pinna et al. Cornea 26:260-264, 2007.)2 Mild-moderate DE (Brignole-Baudouin et al. Acta Ophthalmologica 89:e591-7, 2007.)

2 Post-menopausal women (HydroEye) (Sheppard JD, Pflugfelder SC, et al. Cornea 32 :1297-1304, 2013.)

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$Prostaglandins¬ Myth buster- they are not all bad

$Prostaglandin E1 (PGE 1) -good¬ Shown to stimulate lacrimal production (Phalpramool, 1980, 1983)

¬ Supports mucin production 2 Conjunctiva, other membranes (Viau, 2009, Willemsen, 2003, Nygren, 1984)

¬ Experimental deprivation of vitamin C a required cofactor for PGE 1 2 Stops lacrimal production, produces Sjögren's-like signs & symptoms Wood, 1970

¬ Precursor GLA

$Prostaglandin E2 (PGE 2) – bad¬ Precursor AA

$Prostaglandin E3 (PGE 3)- good¬ Precursor Omega-3 “fish oil”


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Gamma-Linolenic Acid GLA$Consistently shown improvement in markers of inflammation /

inflammatory mediators in dry eye$Shown promise in other inflammatory diseases, like rheumatoid

arthritis, IBD, dermatitis, and diabetic retinopathy$In Sjögren's increases tear production, raises PGE1 in tears (Aragona, 2005)

$Supports meibomian glands ((Pinna, 2007)

¬ Probably through anti-inflammatory action

$2,000-3,000 mg omega-3s usually required to have significant effect¬ In contrast 235 mg of GLA significantly reduced 2 different inflammatory

markers (HLA-DR, CD11c) in the HydroEye trial (Sheppard, Pflugfelder, Whitley et al. Cornea, 2013)

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Is GLA offered in the triglyceride (TG) form? aka “re-esterified”

$These forms of omegas triglyceride (TG) vs ethyl ester (EE) mainly apply only to fish oils

$ Fish oil when it’s purified is transformed from the natural TG form in fish to the EE form¬ Which allows the omegas to be concentrated & purified

$ Fish oil companies have heavily marketed re-esterified or TG fish oils as vastly more absorbable and bioavailable

$ GLA only comes as TG form¬ No other form¬ TG vs EE discussion is purely about different fish oils

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$Pick the right nutraceutical not “fish oil” ad get:¬ Improvement in irritation symptoms ¬ Better cornea smoothness

¬ Significantly lower levels of inflammatory markers


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February 14, 20/20


Regenerative Healing

Amniotic MembraneProkera

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Amniotic Membrane

$To help reset the eye from a stage 3-4 back to something manageable$Failure on multiple therapies$Sjogren’s and the rheumatological patient

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Dry Eye and Amniotic Membrane

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Neurostimulation



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Ocular Surface Disease/Dry Eye

$ Aqueous production¬ True Tear-Allergan

2 FDA approved (April 25, 2017)

2 New development for treatment of ocular surface disease2 Intranasal Tear Neurostimulator

2 Uses mild electric pulse to stimulate branch of trigeminal V1

2 Research showing stimulates all 3 layers of the tear film

2 Disposable end caps need to be replaced daily

2 Sold by docs and/or Allergan and tips prescribed by optometrist

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In-Office Lab Testing



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February 14, 20/20


In-Office Lab Testing

$Helps with:¬ Switching patient to dailies¬ Starting nutraceuticals

¬ Starting pharmaceuticals¬ Following patients over time

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TearLab Osmolarity TestTearLab Osmolarity Test

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TearLab Osmolarity Test

$300 and above¬ Helps confirm dry eye

$Asymmetry ¬ Helps confirm unstable tear film

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TearLab Discovery™ Assay Platform

$Panel Testing of Tear Fluid Biomarkers¬ Tear Osmolarity plus inflammatory marker¬ Capable of quantitative measurement

¬ Single 100 nanoliter tear collection.

$Fluorescent Immunoassay$Rapid < 2 minutes from collection to result$Study Panel: DED + Inflammation

¬ Osmolarity¬ MMP-9

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TearLab Discovery™ Assay Platform

Control Spots Intensity Calibration

Protein SpotsSignal Detection

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Traditional Lateral Flow Tests Highly Volume Dependent

Traditional lateral flow tests need to collect upwards of 10 µL of sample which is not generally feasible to sample in clinical practice. In DED patients, much less than 1 µL is readily available without reflex tearing.

1 µL 2 µL 10 µL

≈ 40ng/mL

500ng/mL

TearLab Discovery™ requires about 100 nL, 1/100th of the

volume required by traditional tests

*TearLab data on file

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February 14, 20/20


TearLab Discovery™ Compares Well to InflammaDry®

Despite using 1/100th the volume of tear fluid, TearLab Discovery shows

good agreement with the InflammaDry® method

TearLab = 0.1 µLInflammaDry = 10.0 µL

*TearLab data on file

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TearLab Discovery™ Platform Timing

$ 510(k) submission in January 2017

$ Expected approval à 2019

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InflammaDry®

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InflammaDry®For inflammatory dry eye detection

Normal levels of MMP-9 in human tears ranges from 3-41 ng/ml

NEGATIVE TEST RESULT

MMP-9 < 40 ng/ml

POSITIVE TEST RESULTMMP-9 ≥ 40 ng/ml

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InflammaDry

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Sjö Diagnostic Test

$ Uses proprietary biomarkers to create an advanced diagnostic panel

$ Early detection of Sjögren’s syndrome in your patients

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February 14, 20/20


Thank-Youand

Hope You Enjoyed

Greg Caldwell, OD, [email protected]

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Clinical Pearls for Management of Dry Eye Disease 1 hour · Clinical Pearls for the Managemnet of...

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