IDENTIFY DRY EYE AN IN-OFFICE TEST TO AID IN DRY EYE DIAGNOSIS. 85% Sensitivity, 94% Specificity 1. This brochure is for use in Canada only.

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1 IDENTIFY DRY EYE AN IN-OFFICE TEST TO AID IN DRY EYE DIAGNOSIS 85% Sensitivity, 94% Specificity 1

2 IDENTIFY DRY EYE WITH INFLAMMADRY InflammaDry is the first and only rapid, in-office test that detects MMP-9, an inflammatory marker that is consistently elevated in the tears of patients with dry eye disease. 2 Using direct sampling microfiltration technology, InflammaDry accurately identifies elevated levels of MMP-9 protein in tear fluid samples taken from the inside lining of the lower eyelid, the palpebral conjunctiva. InflammaDry is a disposable, low cost test that requires no additional equipment to administer or interpret results. Using four simple steps, InflammaDry test results are achieved in just 10 minutes, aiding in diagnosis and allowing a treatment plan to be established with the patient during their office visit. DRY EYE DISEASE OVERVIEW Dry eye disease, also called dysfunctional tear syndrome, is an extremely common condition that is often under diagnosed and affects 5-30% of the population ages 50 and over. 3 Inflammation and tear osmolarity are the underlying mechanisms that cause dry eye. When tears are not able to produce adequate moisture, the ocular surface becomes inflamed. 4 Common symptoms of dry eye, as described by patients include: 5 burning dryness light sensitivity blurred vision foreign body sensation visual fatigue ocular pain discomfort Quality of life and daily activities can be negatively impacted by dry eye symptoms, which creates a significant psychological impact. 6 Patients have reported a willingness to trade years at the end of their lives to be free of dry eye disease. 7 Contact Lens Wear Ocular Surgery COMMON CAUSES OF DRY EYE Prolonged Computer Use Age - Women > 40

3 IMPORTANCE OF DIAGNOSIS The impact that dry eye has on a person s life tends to be underestimated. Daily activities like working, night driving, computer use, reading, and contact lens wear all become difficult. 3 Without a proper diagnosis, dry eye can contribute to even more severe problems like ocular irritation and visual morbidity. 8 Dry eye disease is often under diagnosed, particularly in patients who have reduced corneal sensitivity and do not report symptoms. 9 As MMP-9 levels elevate, there becomes greater risk for deranged corneal epithelial barrier function, increased corneal desquamation, and corneal surface irregularity. 8 Inflammation is present long before the clinical signs of dry eye. 8 Diagnosing dry eye is critical to implementing a proper treatment plan to prevent further damage to the ocular surface. Point-of-care testing will improve management and treatment of patients with ocular surface infection and inflammation. 10 Christopher E. Starr, MD MATRIX METALLOPROTEINASE Matrix Metalloproteinase (MMP-9) levels increase and decrease during the inflammatory process, making MMP-9 a clinically relevant marker for identifying dry eye. Stressed epithelial cells produce MMP-9 enzymes. 11 MMP-9 is elevated in the tears of dry eye patients. 5 MMP-9 is a more sensitive diagnostic marker for dry eye than clinical signs alone. 11 Increased MMP-9 activity in dry eyes may contribute to deranged corneal epithelial barrier function, increased corneal epithelial desquamation, and corneal surface irregularity. 8 MMP-9 AND DRY EYE SEVERITY MMP-9 activity is significantly higher in patients with dry eye and increases as dry eye severity progresses. 11 Abnormal levels of MMP-9 (>40ng/ml) have been shown to correspond with moderate-tosevere dry eye disease, as defined by the Dry Eye Workshop(DEWS) Report. 4,11 Patient s Dysfunctional Tear Syndrome Level Normal (n=18) MMP-9 AND DRY EYE SEVERITY Average MMP-9 Level 8.39 ng/ml Statistical Significance vs Normal No Severity Level 1 (n=15) ng/ml No Severity Level 2 (n=11) Severity Level 3 (n=9) Severity Level 4 (n=11) ng/ml ng/ml ng/ml Yes Yes Yes } POSITIVE RESULT = CHRONIC DRY EYE 40 ng/ml

4 CYCLE OF INFLAMMATION The cycle of inflammation illustrates that the initial cause of dry eye symptoms is undetermined. It is unknown whether inflammation leads to the the generation of hyperosmolar tears, or if hyperosmolarity triggers inflammation, resulting in elevated levels of MMP-9. No matter which stress factor starts first, the end result is dysfunction of the ocular lacrimal unit. 4 Hyperosmolar Tears Nerve Stimulation Irritaton, External Stresses Tear Dysfunction Instability Low Humidity Cycle of PInflammation Contact Lens Wear, Prolonged Computer Use, Reduced Corneal Sensaton, hysical Conditons Eyelid Disorders, Age, Previous Refractve Surgery, Medicaton, Menopause Cytokine Release Systemic Diseases Sjögren s Syndrome, Graf Versus Host Disease, Lupus, Thyroid Disease, Rheumatoid Arthritis Symptoms Excessive Tearing, Dryness, Itching, Irritaton, Blurred Vision, Light Sensitvity, Foreign Body Sensaton Infammation / MMP-9 Ocular Surface Disease

5 DIAGNOSING DRY EYE WITH INFLAMMADRY The lack of correlation between clinical signs and symptoms of dry eye disease makes diagnosing and treating patients a challenge. Now there is a solution to this problem. InflammaDry is the first and only rapid result, in-office test that detects elevated levels of MMP-9, an inflammatory marker that is consistently elevated in the tears of patients with dry eye disease. 11 Identifying patients with dry eye provides the opportunity for better dry eye or perioperative management, which leads to many clinical advantages, such as improved surgical outcomes, reduced complications, and better patient care. 12 POSITIVE Test Result MMP-9 40 ng/ml NEGATIVE Test Result MMP-9 < 40 ng/ml INFLAMMADRY SIMPLE 4-STEP PROCESS Step 1 - Collect Sample Step 2 - Assemble Test Step 3 - Run Test Step 4 - Read Results POSITIVE NEGATIVE INVALID Gently dab the sample collector in 6-8 locations on the palpebral conjunctiva, until the fleece glistens, to collect a tear sample. Snap the sample collector into the test cassette and press firmly where indicated. A double-click means the test is properly assembled. Immerse the absorbant tip into the provided buffer vial for 20 seconds. Replace the cap and lay the test flat on a horizontal surface. After 10 minutes, read the test results. RED + BLUE = POSITIVE BLUE = NEGATIVE

6 CONFIDENCE IN DIAGNOSING WITH INFLAMMADRY InflammaDry recognizes elevated levels of MMP-9 to identify patients that may otherwise be missed with other dry eye testing methods. All other dry eye tests measure tear production and stability. InflammaDry: Detects elevated levels of MMP-9 in tear fluid, to identify inflammation. Provides rapid results in just 10 minutes. Is accurate, with higher sensitivity and specificity than other dry eye tests. Is a disposable, in-office diagnostic test that requires just 4 easy steps. Is a low cost test that requires no additional equipment to administer or interpret. MMP-9 detection may be the single best test available to diagnose dry eye disease and ocular surface disease, to predict the value of anti-inflammatory treatment, and to use preoperatively to reduce post surgical complications. 13 Herbert E. Kaufman, MD CLINICAL BENEFITS OF IDENTIF YING DRY EYE Therapeutic treatment of dry eye improves patient quality of life. By identifying and treating patients with dry eye, pre-surgical measurements are more accurate and post-surgical outcomes are improved. 12 Reduce post-surgical complications, such as corneal wound healing, by identifying and treating dry eye prior to surgery. 8 CYCLOSPORINE AND MMP-9 Anti-inflammatory treatments that are safe for chronic use and normalize tear film composition in the early stages of dry eye disease have the potential to slow, prevent or reverse disease progression. 14 The use of topical cyclosporine has shown to have a significant effect in improving the signs and symptoms of dry eye. After two months of cyclosporine treatment, dry eye patients experienced increased tear film stability and decreased MMP-9 expression in conjunctival epithelial cells. 15 THE EFFECT OF CYCLORSPORINE ON MMP-9 ACTIVITY 15 MMP-9 Activity Units N=24 Eyes of Patients with Thyroid Orbitopathy-related Dry Eye Baseline Two Months After Cyclorsporine Treatment

7 PREOPERATIVE DRY EYE ASSESSMENT PRACTICE WORKFLOW LASIK or Cataract Surgery Posi ve MMP-9 40 ng/ml Provider performs diagnos c test InflammaDry Detec on of MMP-9 Levels Provider interprets test results and other clinical data Nega ve MMP-9 < 40 ng/ml Treatment Op ons Consider: Cyclosporine +/- Steroids (short course) + Ar ficial Tears, Omega-3 Fa y Acids Signs Present Ar ficial Tears If already on Ar ficial Tears, consider: Omega-3 Fa y Acids, Punctal Occlusion. If no improvement, consider: Cyclosporine Signs Absent Ar ficial Tears DRY EYE TESTS Test Sensitivity Specificity Requires Capital Equipment InflammaDry 1 85% 94% NO Schirmer 16 42% 76% NO T-BUT 16 92% 17% NO Corneal Staining 16 63% 89% NO Tearlab Osmolarity System 17, % 71-92% YES

8 DRY EYE PRACTICE WORKFLOW Provider performs history & evalua on Burning S nging Foreign Body Sensa on Fluctua ng Vision Tearing Provider performs diagnos c test InflammaDry Detec on of MMP-9 Levels Provider interprets test results and other clinical data Posi ve Nega ve MMP-9 40 ng/ml MMP-9 < 40 ng/ml Treatment Op ons Consider: Cyclosporine +/- Steroids (short course) + Ar ficial Tears, Omega-3 Fa y Acids Signs Present Schirmer < 10mm OR TBUT < 10 sec OR Staining Present Signs Absent Asymptoma c or Improved No addi onal InflammaDry tes ng required. Con nue: Cyclosporine, Ar ficial Tears, Omega-3 Fa y Acids 2-3 Month Follow Up Symptoma c If pa ent is s ll symptoma c a er 90 days of treatment, repeat InflammaDry tes ng. Ar ficial Tears If already on Ar ficial Tears, consider: Cyclosporine, Punctal Occlusion, Omega-3 Fa y Acids Ar ficial Tears Posi ve MMP-9 40 ng/ml Nega ve MMP-9 < 40 ng/ml Treatment Op ons Con nue: Cyclosporine, Ar ficial Tears, Omega-3 Fa y Acids Consider: Punctal Occlusion, Steroids Treatment Op ons Con nue: Cyclosporine, Ar ficial Tears, Omega-3 Fa y Acids Consider: Punctal Occlusion InflammaDry is promising because it can help us diagnose before someone becomes symptomatic. Studies have shown earlier diagnosis and treatment is an important factor in preventing progression. 19 Parag A. Majmudar, MD

9 CONFIDENCE IN DIAGNOSING DRY EYE IDENTIF Y DRY EYE DISEASE InflammaDry is an easy-to-use, in-office test that provides accurate results in just 10 minutes. Using direct sampling microfiltration technology, InflammaDry detects elevated levels of MMP-9 protein in tear fluid from patients suspected of having dry eye. This diagnostic test is useful for the following types of patients: Dry eye sufferers Dry eye suspects At risk for dry eye The InflammaDry test is nice because you take samples from the palpebral conjunctiva and within minutes you have a readout not unlike a pregnancy test two lines and there s excessive inflammation on the surface, one line there s not, 20 John D. Sheppard MD BETTER SURGICAL OUTCOMES Pre-surgical patients should be screened for inflammation associated with dry eye to avoid negative outcomes 8 Although often asymptomatic, as many as 75% of patients may have signs of dry eye when tested prior to LASIK surgery 21 CLINICALLY RELEVANT MMP-9 is elevated in patients with dry eye disease 11 Dry eye in pre-or-post surgical patients may negatively impact outcomes 5 HIGHLY ACCURATE 85% Sensitivity 1 94% Specificity 1 RAPID Results in 10 minutes 10 min References [1] RPS InflammaDry sensitivity and specificity was compared to clinical truth in RPS clinical study: protocol # [2] Chotikavanich S, de Paiva CS, Li de Q, et al. Production and activity of matrix metalloproteinase-9 on the ocular surface increase in dysfunctional tear syndrome. Invest Ophthalmol Vis Sci Jul;50(7): [3] The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf Apr;5(2): [4] The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf Apr;5(2): [5] Sambursky R, Davitt WF 3rd, Latkany R, et al. Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye. JAMA Ophthalmol Jan;131(1):24-8. [6] Vitale S, Goodman LA, Reed GF, et al. Comparison of the NEI-VFQ and OSDI questionnaires in patients with Sjögren s syndrome-related dry eye. Health Qual Life Outcomes Sep 1;2:44. [7] Schiffman RM, Walt JG, Jacobsen G, et al. Utility assessment among patients with dry eye disease. Ophthalmology Jul;110(7): [8] Sambursky R, O Brien TP. MMP-9 and the perioperative management of LASIK surgery. Curr Opin Ophthalmol Jul;22(4): [9] Kaufman HE. The practical detection of mmp-9 diagnoses ocular surface disease and may help prevent its complications. Cornea Feb;32(2): [10] Starr CE. Point-of care testing leads to improved surgical outcomes. Adv Ocul Care Apr/May:1-2. [11] Chotikavanich S, de Paiva CS, Li de Q, Chen JJ, Bian F, Farley WJ, Pflugfelder SC. Production and activity of matrix metalloproteinase-9 on the ocular surface increase in dysfunctional tear syndrome. Invest Ophthalmol Vis Sci Jul;50(7): [12] O Brien TP. Optimizing the ocular surface to improve outcomes with LASIK. Cataract and Refractive Surgery Today Sep: [13] Kaufman HE. MMP-9 and its role in dry eyes. Adv Ocul Care Oct: [14] Wilson SE, Stulting RD. Agreement of physician treatment practices with the international task force guidelines for diagnosis and treatment of dry eye disease. Cornea Apr;26(3): [15] Gürdal C, Genç I, Saraç O, et al. Topical cyclosporine in thyroid orbitopathy-related dry eye: clinical findings, conjunctival epithelial apoptosis, and MMP-9 expression. Curr Eye Res Sep;35(9): [16] Versura P, Frigato M, Cellini M, et al. Diagnostic performance of tear function tests in Sjogren s syndrome patients. Eye (Lond) Feb;21(2): [17] FDA Section 510(k) number k for TearLab Osmolarity System; May 5, [18] Lemp MA, Bron AJ, Baudouin C, et al. Tear osmolarity in the diagnosis and management of dry eye disease. Am J Ophthalmol May;151(5): [19] Dalton M. New devices for ocular surface disease. EyeWorld Sep: [20] Dalton M. Quantitative metrics for dry eye. EyeWorld Apr: [21] Shtein RM. Post-LASIK dry eye. Expert Rev Ophthalmol Oct; 6(5): Rapid Pathogen Screening, Inc Delainey Court Sarasota, FL USA RPSdetectors.com 2013 Rapid Pathogen Screening, Inc. All Rights Reserved. FORM-MKT For a clear picture in dry eye cases, call , or visit

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