Dry Eye Disease Update

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Dry Eye Disease Update Feb 2013 Dr. Samuel Kim Director of Physician Training earscience, Inc. skim@tearscience.com

Iconoclasts The Dr. Who Drank Infectious Broth, Gave Himself an Ulcer, and Solved a Medical Mystery The medical elite thought they knew what caused ulcers and stomach cancer. But they were wrong. by Pamela Weintraub From the March 2010 issue Published online April 8, 2010 Dr. Barry Marshall

Review - Tear Film

Traditional Evaluation Methods Shirmer Tear Test Fluorescein Tear Break-up Time Rose Bengal & Lissamine Green Staining

Quantifying Tear Evaluation

Traditional Treatment Options Antibiotic Immunosuppressive Topical corticosteroids Dietary Supplements Lacrimal Plugs Warm compress with eyelid scrubs & massage Tear Substitutes

Warm Compress & Hygiene

56 Different Formulations as of Q1 2013* *For USA, not including private formulations & off label use.

Summary of Tear Substitutes 83% of the drops address only lubrication 39.6% are preservative free 3 product addresses evaporation Only 1 product is preservative free 1 product addresses inflammation & is preservative free 100% ointment have same active ingredients 71% are preservative free

Economic Burden of Dry Eye 1 1 Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea 2011; 30(4):379-87.

Updated Classification of DE

Dry Eye Market - 2012 Aqueous ONLY 14.5% Evaporative ONLY 49.7% Aqueous & Evaporative 35.8% In a 2012 study by Lemp et al, 85.5% of patients evaluated had Evaporative Dry Eye Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31(5):472-478.

Meibomian Glands The Meibomian glands, located in the both the upper and lower lids, provide the secretions which makes up the outermost lipid layer of the tear film. In humans, more than 90 different proteins have been identified in the lipid layer. 1, 2, 3

Meibomian Glands Over Time Upper Eyelid Lower Eyelid

Preventative Therapy Dr. Heiko Pult in Meibography in Clinical Practice June 2012 Ophthalmology Times Europe

Meiboscale

Evaporative Dry Eye Cascade Obstructive MGD Decrease in lipid secretion (Evaporation increases by factor of 4 16x) Decrease in Aqueous layer thickness Unstable tear film Micro Trauma Inflammation (Hyperosmolarity) Dry Eye, Conjunctivitis, Blepharitis

Dry Eye Disease as a Process It is NOT a binary condition Yes / No Present / Not Present It is link to our Age Health Environment Behavior

Rise in DE.. Why?

Digital Media Use Over Time 2009-2010

Changes in way we work

Changes in. our life span Above chart courtesy of : Broken Limits to Life Expectancy Jim Open and James W.Vaupel

Sun Damage Over Time JAMA June 2012 The 66-year-old truck driver suffers from unilateral dermatoheliosis or photo-aging, which was caused by repeated, long-term exposure to UVA rays of the sun. William (Bill) Edward McElligott is two different ages, 66 and 86 years old. If you look at McElligott from the right, he looks like any 66-year-old would expect to, but from the left, wrinkles and sagging skin place him far beyond his years. He is a living demonstration of the importance of protecting your skin from the sun. For almost 30 years, McElligott drove a truck during prime sun hours throughout the city of Chicago delivering milk to stores and gas stations.

UV Blocking C. Choy et al. Antioxidant Content and Ultraviolet Absorption Characteristics of Human Tears Optometry and Vision Science Vol 88, No 4 April 2011: 507-511

Blink Rate A Cruz et al Spontaneous Eyeblink Activity The Ocular Surface 2011Vol 9, No 1: 29 41

Characteristics of Lipid Layer Balanced interrelationship between proteins, polar & nonpolar lipids, length of fatty acids and alcohols, their hydroxylation are essential in contribute to their thixotropic characteristics as well as optimal barrier properties. J P McCulley and W Shine A compositional based model for the tear film lipid layer. Trans Am Ophthalmol Soc. 1997; 95: 79 93

Pool of Non-Newtonian Fluid

Characteristics of Lipid Layer Balanced interrelationship between proteins, polar & nonpolar lipids, length of fatty acids and alcohols, their hydroxylation are essential in contribute to their thixotropic characteristics as well as optimal barrier properties. J P McCulley and W Shine A compositional based model for the tear film lipid layer. Trans Am Ophthalmol Soc. 1997; 95: 79 93

VA Decay Between Blinks

With DE patients, we are.. Under estimating.. their prevalence in our practice. their out of pocket expense. Evaluating their condition with less than perfect methodologies Offering inadequate treatment options

TearScience, Inc. Symptoms Diagnosis Treatment

SPEED Questionnaire Understanding patient s dry eye symptoms Dryness, Grittiness or Scratchiness Lubrication, mechanical trauma and lid wiper Soreness or Irritation Non-specific result of all factors Burning or Watering Usually specific to ocular surfaces Eye Fatigue Frequently prolonged insult

LipiView Analysis

Meibomian Gland Evaluator

MGE Video

Regions of Evaluation Highest number of secreting MGs is in the nasal region.* Lowest number of secreting MGs is in the temporal region.* Temporal Central Nasal There is correlation between number of secreting MGs in the lower eyelid and dry eye symptoms.* *Korb DR, Blackie CA. Meibomian Gland Diagnostic Expressibility: Correlation with Dry Eye Symptoms and Gland Location. Cornea Dec;27(10):1142-7, 2008.

Upper & Lower MG Function

Types of Meibum Grade 3: Clear liquid oil Grade 2: Colored liquid Grade 1: Semi-Solid Grade 1: Inspissated Grade 0: Blocked Grade 0: Atrophy

Olive Oil

Olive Oil maturing

BASIC Grading Consider only the number of meibomian glands yielding liquid secretion (MGYLS). Clear and cloudy liquid oil are considered the same = LIQUID secretion Remember to depress the MGE only half way

MG Atrophy Sequence Dr. Heiko Pult in Meibography in Clinical Practice June 2012 Ophthalmology Times Europe

MG Visualization

Transillumination of Abnormal MGs

Meiboscale

MG duct block by epithelium Obstruction of duct Blocked meibum Duct Total obstruction NO SECRETION with MGE MG structures present via transillumination NO SECRETIONS or MATERIAL despite extreme pressure

Line of Marx - Normal Conjunctiva

Line of Marx Mod Change Conjunctiva

Line of Marx Severe Change Conjunctiva

Debridement Lissamine Green

Debridement - Lower

Debridement - Upper

Lid Margin Seal Test Goal To assess the completeness of the lid margin closure/contact during deliberate but relaxed lid closure. This test only approximates what actually happens during sleep. Unlike during the exam, during sleep the patient is in a fully relaxed state. This test is qualitative There is no standardization of exactly how and where the transilluminator is applied to the outer eyelid surface. There is no method to quantify the amount of visible illumination of the eyelid margins.

Complete Seal NO VISIBLE ILLUMINATION OF THE LID MARGINS: - Indicates high likelihood that lids do seal sufficiently seal during sleep - The likelihood of patients symptoms and signs due to lid closure during sleep is low.

Incomplete Seal SIGNIFICANT VISIBLE ILLUMINATION OF THE LID MARGINS: - Length of illuminated lid margin and intensity of illuminated lid margin are significant. - Indicates high likelihood that lids do not sufficiently seal during sleep. - The lack of sufficient lid closure is likely to result in patient symptoms/signs.

Patient s Best Interest SPEED Blink Profile MG Profile Lid Profile LipiFlow Tx Emulsion Tx Aqueous Tx

LipiFlow

Placement

LipiFlow Treatment

LipiFlow Disp During Treatment

Clinical Results

Treatment Duration

Post-LF Treatment Expectations based on evaluation LipiView ICU & Partial Blink MGE MG Structure Eyelid Seal Supplemental Therapy Inflammation Lotemax Ointment Evaporation Day Systane Balance PRN Sleep Preservative Free Ophthalmic Ointment Mindful Blinks Lid Hygiene Emphasis on lower nasal & central eyelids

Germany

France 53% decrease in dry eye symptoms Meibomian Gland Functionality SPEED Score

Absolute Contraindications Recent eye surgery, eye injury or a Herpes infection of the eye of eyelid. Chronic recurrent eye inflammation within the prior 3 months Current eye infection or eye inflammation Eyelid abnormality that affects eyelid function

Relative Contraindications Eye surface abnormality that may affect the integrity of the eye surface Keratoconus Partial Eye Blinks Incomplete Eye Lid Seal Systemic Auto-Immune Condition Sjogren, Lupus, Rheumatoid Arthritis, etc.

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