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Innovations in Ocular Surface Disease

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Innovations in Ocular Surface Disease 1/22/2018 Disclosures - Walter O. Whitley, OD, MBA, FAAO has received consulting fees, honorarium or research funding from: Innovations in • Alcon • J&J Vision • Allergan • Ocusoft Ocular Surface Disease • Bausch and Lomb • Science Based Health COPE#55203-AS • Biotissue • Shire • Beaver-Visitec • Sun Pharmaceuticals Walter O. Whitley, OD, MBA, FAAO • Carl Zeiss Meditec • TearLab Corporation Director of Optometric Services • Glaukos • Tearscience Virginia Eye Consultants • Residency Program Supervisor Collaborative Eye – Co-Chief Medical Editor • Review of Optometry – Contributing Editor PCO at Salus University • Optometry Times – Editorial Advisory Board Virginia Eye Consultants Tertiary Referral Eye Care Since 1963 2016-2017 An Exciting Year for FDA Approvals • John D. Sheppard, MD, MMSc • Walter O. Whitley, OD, MBA, FAAO • Raindrop Near Vision Inlay – Revision Optics • 3D OCT-1 Maestro – Topcon • Stephen V. Scoper, MD • Cecelia Koetting, OD, FAAO • Tecnis Symfony – J&J • GYC-500/GYC-500 Vixi Green Scan Laser Photocoagulater – Nidek • David Salib, MD • Christopher Kruthoff, OD, FAAO • Cypass Microstent – Alcon • MP-3 Microperimeter • Elizabeth Yeu, MD • Jessica Schiffbauer, OD • Angiovue Imaging – Optovue • Plex Elite 9000 Swept Source OCT – Carl Zeiss • Thomas J. Joly, MD, PhD • Kelsey Butler, OD • Triggerfish – Sensimed • Zerviate – Nicox • Dayna M. Lago, MD • Mark Enochs, OD • KXL System – Avedro • Bromsite - Sun • Constance Okeke, MD, MSCE • Acrysof IQ Restor Activefocus - Alcon • Humira – Abbvie • Jay Starling, MD • Light Adjustable IOL - RxSight • Photrexa Viscous and Photrexa - Avedro • Samantha Dewundara, MD • SMILE – Carl Zeiss • Lucentis - Genentech • Rohit Adyanthaya, MD • Xen Glaucoma Stent – Allergan • Xiidra – Shire • Vyzulta – Bausch • Albert Cheung, MD • Restasis Multidose - Allergan • True Tear – Allergan • Insight 100 – Acrscan • Icare HOME Tonometer – Icare USA Today’s Optometrists TFOS DEWS II Definition “Dry eye is a multifactorial disease of the ocular surface “To be on the cutting edge of optometry, characterized by a loss of homeostasis of the tear film, and you need to be on the cutting edge of accompanied by ocular symptoms, in which tear film instability science and technology.” and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.” 1 1/22/2018 Fig. 5 Point of Care Testing Dynamic Meibomian Imaging Osmolarity LIPCOF MMP-9 Corneal Topography AS-OCT The Ocular Surface 2017 15, 539-574DOI: (10.1016/j.jtos.2017.05.001) Copyright © 2017 Elsevier Inc. Terms and Conditions Biomarkers vs. Conventional Diagnostics POC Diagnostics Guide Treatments Positive Test Sensitivity Specificity Predictive Value (PPV) • Evaluate structure and function of MG • Lipiflow?? Miboflo? IPL?? Schirmer I <10mm1 83% 68% 31% TBUT <10sec1 72% 62% 25% • Presence of inflammation??? • Rx drops?? Punctal Plugs?? TCN?? Staining, rose bengal1 25% 90% 31% Osmolarity >308 mOsms/L2,3 75-95% 88% 87% • Is the tear film stable? • Are additional therapies needed?? MMP-9 ≥40 ng/ml4 85% 94% 97% Lactoferrin <0.9 mg/ml 83% 98% Not available Conv’l Sjögren’s biomarkers5 40-60% 40-60% Not available New Sjögren’s markers7 95% 95% Not available 1.DEWS Report, 2007. Ocul Surf 2007;5(2):108-52. 2. Sullivan BD, Whitmer D, Nichols KK, et al. Invest Ophthalmol Vis Sci 2010;51(12):6125-30. 3. TearLab Osmolarity Test, Package Insert. 4. InflammaDry Package Insert-English, Canada, Rapid Pathogen Screening, Inc. 5.Huang Y, Cheng Q, Jiang C, et al. Clin Dev Immunol 2013. 6. Finis D, Pischel N, Schrader S, Geerling G. The Ocular Surface 2017 15, 575-628DOI: (10.1016/j.jtos.2017.05.006) Cornea 2013;32(12):1549-53. 7. Data on file, Nicox Copyright © 2017 Elsevier Inc. Terms and Conditions Leading the Future of Diagnostics Osmolarity in Diagnosis & Grading of Dry Eye • TearLab DISCOVERY™ Platform: • First test card to include: • Quantitative • Osmolarity • Rapid testing (< 2 minutes) • Two Inflammation markers: • Multiplexed biomarkers • MMP-9 • EHR Integration • IL1-Ra 2 1/22/2018 I-PEN® by I-MED Pharma Inc. Tear Film Analyzer - Visiometrics • Quantitative measurement • Rapid results in <5 seconds • Handheld, light & simple to use • Affordable point-of-care testing LipiScan™ High Resolution Meibography Imaging Cloud-based Computing PROACTIVE CARE REACTIVE CARE Easy to Use Increased clinic efficiency Regular Software Updates Small Footprint Very Portable Customized and printable patient reports Central Unit Available Duct dilation, atrophy Severe atrophy and and dropout dropout 16 Fig. 1 Epi-Mapping - Optovue • Quantitative measurements of the epithelial and stromal layers of the cornea • Indications • Refractive surgery • Keratoconus • Dry eye disease • Commercially available on the iVue and iFusion OCT systems Rocha KM, Straziota CP, Stutling RD, et. Al. Spectral-Domain OCT Analysis of Regional Epithelial Thickness Profiles in Keratoconus, Postoperative Corneal Ectasia, and Normal Eyes. J Refract Surg. 2013 Mar; 29(3): 173-179. Li Y, Tan O, and Huang D. Corneal epithelial thickness mapping in Normal and keratoconic eyes with fourier-domain optical The Ocular Surface 2017 15, 575-628DOI: (10.1016/j.jtos.2017.05.006) coherence tomography. Investigative Ophthalmology & Visual Science. April 2010, Vol.51, 5819. Copyright © 2017 Elsevier Inc. Terms and Conditions 3 1/22/2018 RestasisTM (cyclosporine 0..05% ophthalmic emulsion) Works on All Three Layers and Underlying Inflammation Lotemax gel XiidraTM (lifitegrast ophthalmic solution 5%) (loteprednol etabonate ophthalmic gel 0.5%) • Lifitegrast is a small molecule integrin antagonist that interferes with binding of • Ester based steroid ICAM-1 to the integrin LFA-1 on the T cell surface, inhibiting T cell recruitment • Vehicle: Polycarbophil (mucoadhesive polymer matrix) and activation associated with dry eye disease (DED) • A component of the vehicle DuraSite that adheres to mucous membrane-like tissues • Lifitegrast ophthalmic solution 5.0% has been investigated in 3 (one Phase 2 and • This increases retention time and drug penetration 1–3 three Phase 3) randomized controlled trials for treatment of DED • Added moisturizing agents • glycerin and propylene glycol • Preservative: BAK 1. Semba CP, et al. Am J Ophthalmol. 2012;153(6):1050-60. 2. Sheppard JD, et al. Ophthalmology. 2014;121(2):475–83. 3. Tauber J, et al. Ophthalmology. 2015;122(12):2423-31. The Asclepius Panel Recommended Treatment Model for Dry Eye Inflammation TRUETEAR™: PRODUCT INNOVATION Cornea/External Disease Advisory Group Treatment Consensus • First-ever neurostimulation device in eye care Thereafter • An easy-to-use and drug-free option to temporarily increase tear production during neurostimulation in adult patients ® Lotemax® QID Lotemax® BID Lotemax …up to QID for flare-ups (loteprednol etabonate ophthalmic (loteprednol etabonate ophthalmic (loteprednol etabonate ophthalmic suspension 0.5%) suspension 0.5%) suspension 0.5%) • Provides small electrical pulses to stimulate production of your own natural tears Restasis® BID • First “smart” device in eye care with Bluetooth® (cyclosporine ophthalmic emulsion) 0.05%) enabled and connected application Artificial Tears Adapted from Holland EJ. Ophthalmol Times. 2007;32:3-11. 4 1/22/2018 LFU REGULATES TEAR PRODUCTION1-4 BY COMMUNICATING WITH CENTRAL NERVOUS SYSTEM (CNS) CLINICAL DATA • In Study 1, patients saw an approximate 2.5x greater increase in tear production with • Lacrimal Functional Unit (LFU) maintains a healthy environment for the eye by regulating 1 tear production intranasal stimulation on study day compared to sham or external stimulation • Neurostimulation in the nasal cavity targets the trigeminal nerve to trigger the nasolacrimal reflex to emulate the normal neural signals to create a natural tear 1. Kossler et al. Ophthal Plast Reconstr Surg. 2015; 2. Beuerman et al. In: Pflugfelder et al, eds. Dry Eye and Ocular Surface Disorders. 2004; 3. Dartt. Ocul Surf. 2004. 4. Freidman et al. A nonrandomized, open-label study to evaluatethe effects of nasal stimulation on tear production in subjects with dry eye disease. 2016 1. Data on file, Allergan; OCUN-009 GOBLET CELL DEGRANULATION WITH THE INTRANASAL NEUROSTIMULATOR CLINICAL DATA (CONTINUED) Impression Cytology After Neurostimulator Application • In Study 2, clinically and statistically significant increase in tear production was seen at 180 days1 Extranasal Intranasal K Gumus, Shcuetzle K, Pflugfelder S. Randomized Controlled Cross Over Trial Comparing the Impact of Sham or Intranasal Tear 1. Data on file, Allergan; OCUN-010 Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol 2017: 177; 159-168. Tear Biochemistry Tear Biochemistry • Conclusion: Tears stimulated by use of TrueTear contained equivalent concentrations of • Total protein data results: amount of lysozyme and lactoferrin in post- total protein and total lipid compared to the subjects normal (basal or unstimulated) stimulation tears are equivalent to basal tears tears Lysozyme Lactoferrin Total Protein Total Lipid SEM ± SEM SEM ± SEM ± ± Mean Total LipidMean (µg/µL) Mean Total Protein Total Protein Mean (µg/µL) Mean Relative Relative Mean Lactoferrin Level Mean Relative Relative Mean Lysozyme Level Ousler et al 2016; Argueso and Woodward 2016; Basso et al 2016 5 1/22/2018 OTX-101 – Sun Pharmaceuticals NovaTears / EvoTears – Novaliq Inc. • A nanomicellar formulation of cyclosporine 0.09% • Non-preserved tx for evaporative dry eye • In this 12 week, multicenter, randomized, double-masked,
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