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There’s a Better Way

Table of Contents

Market Introduction OSD Prevalence TearLab Osmolarity Test

Established

Empowering OSD Diagnosis Therapy

Advanced dry eye and ocular surface disease management with the TearLab ® Osmolarity Test.

Essential ASCRS Algorithm Impact on Refractive Measurements

Customer Support

Increasing Awareness and Diagnoses of Dry Eye Disease (DED)

30M+ dry eye sufferers in the US*

344M dry eye sufferers worldwide

* http://www.tearfilm.org/dettnews-tfos_dews_ii_report_announced/101_16/eng/

2

Increasing Prevalence of Ocular Surface Disease (OSD)

The incidence of dry eye in patients scheduled to undergo cataract surgery is higher than anticipated. 1

~80% of cataract patients present a sign of OSD 1,2 Studies show that approximately:

1. Gupta, P. K., Drinkwater, O. J., VanDusen, K. W., Brissette, A. R., & Starr, C. E. (2018). Prevalence of ocular surface dysfunction in patients presenting for cataract surgery evaluation. Journal of Cataract & Refractive Surgery, 44(9), 1090–1096. https://doi.org/10.1016/j.jcrs.2018.06.026 2. Trattler WB, Majmudar PA, Donnenfeld ED, McDonald MB, Stonecipher KG, Goldberg DF. The Prospective Health Assessment of Cataract Patients’ Ocular Surface (PHACO) study: the effect of dry eye. Clin Ophthalmol. 2017;7(11):1423-1430.

3

Increasing Prevalence of Ocular Surface Disease (OSD) of which 63% had unstable tear film 2

~80% of cataract patients present a sign of OSD 1,2 Studies show that approximately:

and only 25% had a prior OSD diagnosis 2

1. Gupta, P. K., Drinkwater, O. J., VanDusen, K. W., Brissette, A. R., & Starr, C. E. (2018). Prevalence of ocular surface dysfunction in patients presenting for cataract surgery evaluation. Journal of Cataract & Refractive Surgery, 44(9), 1090–1096. https://doi.org/10.1016/j.jcrs.2018.06.026 2. Trattler WB, Majmudar PA, Donnenfeld ED, McDonald MB, Stonecipher KG, Goldberg DF. The Prospective Health Assessment of Cataract Patients’ Ocular Surface (PHACO) study: the effect of dry eye. Clin Ophthalmol. 2017;7(11):1423-1430.

4

Challenges of OSD Diagnosis

• 56% of patients are asymptomatic 1 • Traditional signs and symptoms don’t correlate

• Signs and symptoms can fluctuate • OSD subsets symptoms overlap 2

1. Starr CE, Gupta PK, Farid M, et al. An algorithm for the preoperative diagnosis and treatment ofocular surface disorders. J Cataract Refract Surg. 2019 May; 45(5): 669-684. 2. Brissette A, Bohm K, Starr C. The utility of a normal tear osmolarity test in symptomatic patients. Poster session presented at: 8th International Conference of The Tear Film & Ocular Surface Society;2016 Sept 7-10; Montpellier, France.

5

The Vicious Cycle of DED

Evaporative DE (Meibomian Gland)

Aqueous Deficient DE (Lacrimal Gland)

Hyperosmolarity (Core Mechanism) Osmolarity Test

Tear Film Instability

Epithelial Stress (MAPK+, NFkB+)

Core Mechanism of Dry Eye Disease

TBUT

Inflammation (IL-1+, TNFa+, MMPs)

Epithelial Damage (Mucin Loss, Apoptosis)

MMP-9 Testing

Staining

1. DEWS Definition and Classification Subcommittee. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:75-92.

6

The Adverse Impact of Untreated OSD

Uncontrolled dry eye is a contraindication for keratorefractive surgery 1 .

It can lead to: • Inaccurate Pre-Surgical Measurements 2 • IOL calculation errors and refractive surprises 2 • Reduces vision quality and visual f luctuations 3 • Impaired surgical outcomes 2 • New or worsened OSD symptoms 2

1. Akpek EK, Amescua G, Farid M, et al. Dry eye s yndrome preferred practice pattern. AAO. January 2019; 126 (1): 286–334. 2. Starr CE, Gupta PK, Farid M, et al. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019 May; 45(5): 669-684. 3. Kam W, et al. Invest Opthalmol Vis Sci. 2016; 57:E-abstract 6181.

7

Normal Osmolarity and Stable Tear Film

1A. NORMAL TEAR FILM BLINK#1

2A. HYPEROSMOLAR, UNST

• 70% of total refractive power occurs at the tear film 1

1. Starr CE, Gupta PK, Farid M, et al. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019 May; 45(5): 669-684.

8

2A. HYPEROSMOLAR, UNSTABLE TEAR FILM; BLINK #2 Abnormal Osmolarity and Unstable Tear Film

2B. HYPEROSMOLAR, UNS

• Abnormal Osmolarity can affect tear film stability and accuracy of presurgical measurements 1,2

1. Starr CE, Gupta PK, Farid M, et al. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019 May; 45(5): 669-684. 2. Gupta PK, Drinkwater OJ, VanDusen KW, Brissette AR, Starr CE. Prevalence of ocular surface dysfunction in patients presenting for cataract surgery evaluation. J Cataract Refract Surg. 2018 Sep; 44(9): 1090-6.

9

2B. HYPEROSMOLAR, UNSTABLE TEAR FILM; BLINK #2 Abnormal Osmolarity and Unstable Tear Film

M; BLINK #2

• Abnormal Osmolarity can affect tear film stability and accuracy of presurgical measurements 1,2

1. Starr CE, Gupta PK, Farid M, et al. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019 May; 45(5): 669-684. 2. Gupta PK, Drinkwater OJ, VanDusen KW, Brissette AR, Starr CE. Prevalence of ocular surface dysfunction in patients presenting for cataract surgery evaluation. J Cataract Refract Surg. 2018 Sep; 44(9): 1090-6.

10

Variability Is the Hallmark of DED

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Normal Subjects 10 r l j t 10

Dry Eye Subjects 10 r j t 10

Higher variability in dry eye subjects

11

1. Keech A, Senchyn M, Jones, L. Impact of time between collection and collection method on human tear fluid osmolarity. Current Eye Research, Early Online, 1-9, 2013.

TearLab Osmolarity Test ® : A Better Way

• Established • Empowering • Essential

12

Osmolarity Test Pen The Pen is designed to hold the Test Card and facilitate safe, simple tear fluid collection. Powered by a permanent rechargeable battery, the Pen provides a mechanical/electrical interface to convey >Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29

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