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Correction Innovations in Eyecare Part II • Accommodating IOLs Paul M. Karpecki, OD, FAAO • Corneal Inlay Technology • Scleral expansion Kentucky Eye Institute, Lexington KY Gaddie Eye Centers, Louisville KY • Pharmaceutical agents/ eye drops Associates of KY UPike KY College of Optometry Chief Clinical Editor, Review of Optometry

Medical Director, TECP 1 2

Elongation Of Focus Extended Depth Of Focus

The TECNIS Symfony® IOL has unique optics, creating a different visual experience

Monofocal IOL

Multifocal IOL

TECNIS Symfony ® IOL ▪ The proprietary echelette design introduces a novel pattern of light diffraction that elongates the focus of the eye1 ▪ The echelette is the relief or profile of the (height differential) within each ring 1. TECNIS® Symfony® IOL DFU 1 Data on File. Tecnis Symfony Green Light Bundle Bench Test DOF2014CT0005. Abbott Medical Optics Inc. 2014 ▪ The height, spacing, and profile of the echelettes to create a diffractive pattern for an elongated focus 3 4

Patient Satisfaction TECNIS Symfony® IOL delivers high patient satisfaction Refocus • Restarted Clinical trial with redesign of method for creating the tunnels Percent of patients who would recommend TECNIS Symfony® IOL to friends and family1,2 • Now called the “VisAbility implant system” 98% 100% 94% 80% 60%

40% 20% 0% Harmony (N=146) Concerto (N=411)

1. DOF2016CT0024 Concerto Study Report, 2. DOF2015OTH0009 Symfony Harmony Observational Study 5 6 The VisAbility™ Micro-Insert System

• Docking Station Incisional System • No marking Place the VisAbility™ • Docking station “locks” with 4- docking station point fixation Create the • Scleratome “docks” into position scleral tunnel

Place the micro-insert using shuttle/tubing

Lock the inserts in place

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How does VisAbility™ work? Uncorrected Near Visual Acuity @ 40cm (Two Sites - Binocular (OU), n=20) • Implants may help the focusing muscles of the eye work better and improve near vision 100% 100% 100% 101% 95% 95% 90% 90% 90% 20/40 (J3) or Better 20/32 (J2) or Better 20/25 (J1) or Better

76%

51%

25% 15%

5% 0% 0% Baseline 3 Month 6 Month 12 Month 9 10

HigherPercent proportion of Subjects of EV06 with subjects Gain of had ≥10 gain of 10 Topical Treatment for Presbyopia Letters in DCNVA letters or more (DCNVA) compared to placebo 50 • Presbyopia Therapies • Contains miotics but also proprietary 38 P=0.04 components that allow full 12-14 hours of P=0.003 Placebo near and far vision 25 EV06

• Encore Vision Subjects % of 13 • Contains drops that selectively target and P-value is based on Fisher’s exact test disrupt the disulfide bonds in the lens 0 Day 8 Day 15 Day 31 Day 61 Day 91

• Total of 3-4 weeks of treatment and DCNVA=Distance-corrected near visual acuity permanent results thus far Note: Preliminary analysis based on LOCF in study eye only 11 12 How Is Lost? What is EV06? How Does it Work?

Young Eye Aging Eye • EV06 (Lipoic Acid Choline Ester, 1.5%) is a prodrug Lipoic Acid Choline Ester

• EV06 penetrates - metabolized into Choline & Lipoic Acid, two ↓ naturally occurring substances

• Enzymes within lens ↑ fiber cells chemically reduce Lipoic Acid Oxidation induced disulfide bonds form between crystalline to active form proteins - a Leading Potential Dihydrolipoic Acid Choline Lipoic Acid Cause

Lens Stiffening = Cytosol Displacement Compromised 13 14 Centrally = Accommodation Accommodation Dihydrolipoic Acid

LENS ELASTICITY IS REGAINED Dihydrolipoic Acid

Dihydrolipoic Acid Chemically Reduces Disulfide Bonds EV06 Safety & Tolerance Results

• No Subjects Discontinued For Adverse Events, Safety Concerns, or Tolerability ↓ • No Sight Related Adverse Events • Upon Instillation – Mean EV06 Comfort Rating 3.0 ↑ – Mean Placebo Comfort Rating 2.7 Disulfide Bonds • (Scale 0 – 10; “0” = Very Comfortable) • No Change In Best Corrected Distance Visual Cytosol Displacement 15 16 Centrally = Accommodation Acuity

Improvement in Distance Corrected Near Vision Acuity EV06 Efficacy Results DCNVA LogMAR - OU 0.5 • Achieved both Primary Efficacy Results:

0.375 – Improvement in Distance Corrected Near Vision • P=0.017 Acuity (DCNVA) in the Study Eye after 0.25 Placebo • P=0.022 EV06 P=0.027 treatment, which continued throughout the • • P=0.005 LogMAR Score

dosing period 0.125

– Higher proportion of subjects with gain of ≥10 0 letters in DCNVA in the study eye vs. placebo 0 25 50 •P-values75 for two sample100 t-test, EV06 vs. Placebo

17 Treatment Day DCNVA=Distance-corrected near18 visual acuity • • EV06 DCNVA Snellen score - Day 1 & Day 91 • • Placebo DCNVA Snellen score - Day 1 & Day 91

40 • Improved shift in Snellen • No material shift 36 Scores in Snellen 32 Scores

24 24 24 22 22 22 20 16 12 12

12 12 % Subjects

% Subjects 8 8 8 8 8 8 0 4 0 4 1 0 0 0 0 0 0

20/20 20/25 20/32 20/40 20/50 20/63 20/80 20/100 20/20 20/25 20/32 20/40 20/50 20/63 20/80 20/100 Day 1 Placebo Day 91 Placebo Day 1 EV06 Day 91 EV06

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RxSight Light Adjustable IOL RxSight Light Adjustable IOL

• Currently available in Europe • 6 mm silicone optic and PMMA haptic • Optometry role IOL • IOL polymer does not have ‘healing’ • Using a UV laser so as to change the issues • UV light adjustable corrects • Post operative enhancement, correction, consistently every time adjustment • Working on payment system currently • Corrections to .1D accuracy but expect post-operative uv light • Can trial mono vision through UV correction as additional protection lenses • Optometry’s role in post-operative treatment is a necessity

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Capsulotomy Tip Zepto® Capsulotomy System Consists Of

Soft, clear Disposable suction cup Handpiece

Capsulotomy Tip

Control Console Nitinol Un-obstructed capsulotomy ring view for visual axis centration

23 24 ZEPTO Operating Principles INTRAOPERATIVELY ANCHORS SURGERY TO THE PATIENTS VISUAL AXIS Center Zepto on • Suction pulls capsule against capsulotomy ring P1*

• Electrical energy applied to ring for 4 Create capsulotomy milliseconds Zepto capsulotomy is • Phase transition of water molecules now reference marker

Align IOL with Precision Pulse Capsulotomy Zepto capsulotomy

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THE BENEFITS OF THE 3D CAPSULE 18 MONTHS POST IMPLANTATION-NO UNIQUE 3D DESIGN YAG ALLOWS: › NO Fibrosis around the lens position › Gemini capsule fills the 3D space of a natural lens. NO issues with position of the Lens, the x, y, and most importantly the z axis. (the most common source of error) › Capsule volume stays intact, allowing for future lens implantations › Gemini offers valuable ‘real estate’ for drug delivery and bio sensors › Maximizes the large size of the implant (200 cubic mms) without compromising the small size of the incision (2.2 mm)

LOW VISION INTRAOCULAR TELESCOPE ASSEMBLY

• Not all AMD patients had THE WIRELESS PRESSURE SENSOR significant disease at the time of surgery • Designed to fit within the central • A platform for modification of slot of the prosthetic capsule the optical state of the eye has • Communicates through tissue up huge benefits to to a peripheral device • The assembled parts can be • Measures IOP 4 times/ hour + - inserted through traditional sub without intervention 3mm incisions. • Easily removed if needed • The telescope can be “tuned” • Central 5mm is an open 3.5 mm for optimal magnification, field aperture of view and prismatic offset. Telescopic IOL for Advanced AMD Telescopic IOL for Advanced AMD

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Glaukos iStent Implantable Miniature Telescopess

• Renders retinal image ~2.7x larger than natural lens • Images seen upon viable perimacular tissue • Field of view 20-24 degrees • 67% achieve >/= 3 lines of improved VA (control = 13% - worse seeing eye for treatment eye)* • Improved ADL’s and Vision-Targeted Psychosocial Domains*

*Hudson H. A team approach helps severely visually impaired AMD patients. Ophthal Management. 2012; 52-54.!

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Glaukos iStent Glaukos iStent

iStent is the smallest medical device known to be implanted in the human body and weighs just 60 µg

Snorkel 0.3 mm Open Half Pipe

Retention Arches

Lumen 120 µm Self-Trephining Tip

35 36 Glaukos iStent

iiStent® is designed to be used in conjunction with cataract surgery to safely and effectively reduce IOP while facilitating the eye’s natural outflow in mild to moderate OAG patients currently on hypotensive medication

• Lowers IOP and may reduce or eliminate medication burden1 • Decrease risk of IOP fluctuations associated with non-adherence to prescription medication regimens • Avoid serious complications associated with end-stage filtration and shunt procedures • Spare the and safely preserve future treatment options • Minimizes risks of hypotony and bleb related complications

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Will MIGS be significant? Ivantis Hydrus • iStent • Xen • -7.6mmHg reduction in • ABiC IOP • InnFocus • Increased IOP reduction at • KDB 2 years compared to 1 • ECP year • iDose • Likely approval in late • iStent Supra 2018 • Hydrus 39 40

The Hydrus Microstent Real-time Confirmation of Accurate Delivery

VIEW FROM ANTERIOR CHAMBER • Flexible, biocompatible 8 mm length microstent Scaffold • Made out of nitinol (highly Visual Confirmation of Inlet biocompatible material used in Proper Placement – No Window s cardiovascular stents) Need for Targeting

• Contoured to match canal curvature

VIEW FROM CANAL • Three open windows face anterior chamber

• The canal-facing surface is completely open for unobstructed collector channel access

Investigational Device in the US Investigational Device Only in US HORIZON: Medication Free Other options for Augmented MEDICATION FREE 0-24 MONTHS Reality Largest treatment effect of all MIGS pivotal trials to date Hydrus Microstent (HM) 100% No Stent (NS)

83% • TruVision Systems

24 65% Months Δ = 30% • LaForge Optical 48% P<0.001 % Unmedicated at Viist

30% Preoperative Wash Out 3M 12M 24M • Innovega

N=369 Hydrus and 187 phaco

Providing the whole picture by both How Eyedaptic Works: maintaining a Wide Field of View and recovering the Central Field Open Market AR Hardware + Proprietary Software 1

View with AMD (central )

Eyedaptic Image View with Display Magnification effectively Capture (this limits the recovers the Field of View) visual field! Vision Simulated Natural w/AMD Adaptive Vision 1 1. Patents pending & FTO completed Systems

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Clinical Trial: Validation of Features Technology Validation A New Timed Instrumental Activities Of Daily Living (TIADL) Measure For Evaluation Of Rehabilitation Outcomes (V.L. Gills1, M.MacKeben2, D.C. Fletcher1,2 ) 30 Users to Date 73 – 105 Age Range 20/60 – 20/400 Vision EYE-01 @ 3X (n=10) Timed Independent 120 25% - 50% Mostly Dry AMD 50% Improvement Improvement Technology K Activities of Daily Living e y validated O % increase in reading speed p 90 i (TIADLs): n improved reading 60% i o n L ▪ Reading a bill e & a d e r everyday tasks 45% ▪ Identifying & Reading 60 s easier food cans 30% ▪ Sign spotting & reading

Timed Daily Living Tasks (sec) Tasks Daily Living Timed 30

15%

0 Rx Only Bill PortalCans Britext Signs 0% 20pt 14pt 12pt 47 10pt 8pt 48 Clinical Trial: Validation of Features Gene Therapy & Genomics Quantitative Evaluation of reading ability and visual acuity • Generic variants causing most ocular diseases are being discovered MNRead Reading Change from Baseline (letters gained) 40 • Examples include , dry AMD, Fuchs’ Assessment: >80% Improvement ▪ Critical print size 30 vs. Baseline and all corneal dystrophies ▪ Reading Acuity ▪ Scotoma pattern 20 • Early treatment vs. repair dependencies 10 • Prevention of disease progression (e.g. Avellino 0 Labs) Ring -10 Scotoma • Ocular anatomy and architecture are uniquely -20 Letters Gained Average EYE-01 situated for gene based research Average Lucentis Average Eylea

Case 1 Slit Lamp Examination Considerations and DDx

• Corneal scarring from long-standing CL wear? • EBMD - Cogan’s or MDF? • Appears to be anterior stromal • A Stromal Dystrophy?

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Autosomal Dominant Inheritance Pattern TGFBI Corneal Dystrophies histologic and clinical appearances

Affected Parent GCD1 GCD2 LCD1 RBCD TBCD If only one parent has a single copy of a dominant allele for a dominant disorder, their children will have a 50% chance of Parent Unaffected inheriting the disorder.

Anterior stroma Anterior stroma Anterior stroma Epithelial stromal Epithelial stromal

Weiss JS, Møller HU, et al. IC3D classification of corneal dystrophies--edition 2. Cornea. 2015 Feb;34(2):117-59. 53 54 Mechanism of TGFBI Induced Corneal Post LASIK Exacerbation Dystrophy OD - No Surgery, 5 years later In 2004 , Jun et al published a case in OCT cross section . A 25 year old female experienced decreased vision five years after LASIK. Genetically confirmed as GCD2

Roo Min Jun, MD, et al. TGFBI Damage Excessive Protein Deposits Opthalmology III.3 (2004):463-468 Gene To Production on Cornea Mutation Cornea Of TGFBIp Protein OCT cross section

OS – 5 years post LASIK

56 55 Proprietary and Confidential

Subtle Phenotype

Right Eye OCT showing protein deposits Daughter - age 21 Mother – age 47 at the interface Patient ‘qualified' for LASIK on slit of the flap No positive family history reported by lamp exam, then genetically tested patient.

Histology slide after penetrating keratoplasty from a similar patient with GCD1 accelerated post LASIK

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Subtle Phenotype CLIA Licensed Diagnostic Laboratory

Daughter - age 21 Mother – age 47 licensed by U.S. Division of Laboratory Services, under the Center Patient ‘qualified' for LASIK on slit No positive family history reported by for Clinical Standards and Quality lamp exam, then genetically tested patient. Tested Positive GCD2 Tested Positive GCD2

Clinical Trial*: *Clinical Trial 100% Sensitivity, Specificity 734 subjects CLIA Testing: 136 normal controls 100% Accuracy, Precision

59 60 AMD – A Genetic Disease EyeCheck

Macula Risk • Akin to “23 and Me” • Only for ocular conditions ranging from A test that identifies AMD AMD and Stargardt’s to Leber’s, Fuchs and patients who will progress even glaucoma to vision loss

Cheek Swab 62

CRISPR Gene Editing and an CRISPR can remove the Adenovirus vector damaged or faulty genes

Modified Adenovirus can present the proper genetic code to the body for integration

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EDITAS

CRISPR followed by injecting the correct code for Leber’s

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AMD Opportunity

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Medical Utility - The AMD Problem Dark Adaptometry Photoreceptors Only 15% to 20% of Early / Intermediate AMD will progress to Advanced disease

How can the Primary Eye Care Professional identify those at Risk? Curcio CA, Johnson M. Structure, function, and pathology of Bruch’s membrane. 72 In: Ryan SJ, et al, eds. Retina, Vol 1, Part 2: Basic Science and Translation to Therapy. 5th ed. London: Elsevier; 2013:466–481. Dark Adaptometry Dark Adaptometry

Photoreceptors Photoreceptors Cholesterol accumulation leads to panmacular deposits (BlinD and BlamD)

Peaks in these deposits Drusen eventually become clinically Drusen visible drusen In effect, AMD causes a localized deficiency of These extracellular cholesterol vitamin A, and dark deposits affect photoreceptor health by impairing transport, adaptation is the best test to causing inflammation, measure this change and predisposing to CNV

In addition, they impair normal transport, including that of vitamin A, across Bruch’s membrane Sclera Sclera Curcio CA, Johnson M. Structure, function, and pathology of Bruch’s membrane. In: Ryan SJ, Curcio CA, Johnson M. Structure, function, and pathology of Bruch’s membrane. In: Ryan SJ, et al, eds. Retina, Vol 1, Part 2: Basic Science and Translation to Therapy. 5th ed. London: et al, eds. Retina, Vol 1, Part 2: Basic Science and Translation to Therapy. 5th ed. London: Elsevier; 2013:466–481. Elsevier; 2013:466–481. 73 74

Dark Adaptometry Dark Adaptometry

First dark adaptometer for rapid, Dark adaptation is the process routine clinical use of adjusting from day vision to night vision Simple, objective tool to measure dark adaptation as earliest Easy-to-measure aspect of functional correlate of macular night vision dystrophies Two clinical protocols • ≤6.5-minute rapid test (for quick assessment) • ≤20-minute extended test (for benchmarking)

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Crizal® prevencia™: front-side blue- Crizal® prevencia™: blue-violet violet light deflection light protection

! Protection from Blue-Violet light ! New No-Glare lens treatment ! Features Light Scan™ ! Selectively deflects harmful Blue- Violet light by 20% ! In recent lab tests, Crizal Prevencia lenses reduced retinal cell death by 25%* ! No other No-Glare lens on the market offers selective protection against harmful Blue-Violet light ! This graph shows the front-side reflection of Visible Light ! 20% Blue-Violet light deflected ! Blue-Turquoise transmitted ! Rest of visible light transmitted

77 78 A Breakthrough Study in Blue Light- BluTech Lenses BluTech(Lenses(( • Nova Southeastern University College of Optometry Filter Blue Light • Study Independently conducted Block UV • Randomized Controlled Crossover Trial (The gold Available as Indoor or Outdoor (Polarized Sunglass) standard) • 24 Subjects wore BluTech after 6:00 PM for 5 days, Lenses and then Clear Lenses with Anti-reflective Coating Plano, Finished RX Indoor, Single Vision, Flat-Top 28 and Only* for the following 5 days • Actigraphy watches noninvasively recorded sleep Progressive Designs patterns • VSP UNITY PLx, Plxtra, CVx • Melatonin samples collected from saliva after day • Shamir Autograph I,II,III + Shamir Computer & Workspace 5 • Mood & neurobehavioral performance assessed • All Kodak Back Surface Progressives (Unique/Precise PB/ with NIH Toolbox Emotion and Cognition Batteries, PB Short) respectively. • Hoya ARRAY Progressive Key Findings: Wearing BluTech for just 5 days, participants • Select Private Label Progressives (IOT) CONCLUSION: demonstrated: Lens, NOT a Coating Wearing BluTech Lenses is clinically 1. Increase in Melatonin levels by 96% (P=0.036) proven to double your nighttime Lens Monomer infused with Ocular Lens Pigment and 2. Less awakening during sleep, reduced sleep Melatonin levels, which MAY Melanin Pigment improve sleep and cognition. onset latency 79 3. Improved cognition using pattern80 comparison test (P=0.047)

DGH Technology’s UltraSound Keys to Determining if a Nevus is a Choroidal Melanoma

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Keys to Determining if a Nevus Keys to Determining if a Nevus is a Choroidal Melanoma is a Choroidal Melanoma

1. Symptoms 1. Height over 2mm on ultrasound 1. Flashes 2. Subretinal fluid on or off the lesion 2. 3. Increasing basal diameter 3. Decreased VA 2. Orange pigment (lipofuscin) on the surface of the lesion 3. Touching the disc margin area

83 84 Common Indications for B-Scan Ultrasound Testing • Nevi • PVD • Potential RD (flashes/floaters/cobwebs) • Obstructed view to the retina • Opaque • Dense • Vitreous hemorrhages • • head drusen

85 86

Common Indications for Ultrasound Testing

• • Asteroid hyalosis • Dislocation of lens • Trauma • Hyphema • Intraocular foreign bodies • Any potential intraocular tumor

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Common Indications for Another application: Control Ultrasound Testing

• Valuable in differentiating:

• Choroidal detachments (serous v. hemorrhagic) • RDs (rhegamatogenous v. exudative) • Retinal tear v. v. retinoschisis • ONH drusen from

89 90 Patient John Doe Dr. Smith ID# 020419153310 DGH Technology, Inc. DOB 01 Jan 1960 110 Summit DR; Suite B Gender Male Exton, PA 19341 Robotics in Ophthalmic Surgery Practice Phone

Axial Length Progression

OD Average Measurements (mm) 4 Files Scan Lens Vitreous Change from ScanDate Ct. Rank ACD LT VCD AXL Type Type Type Prev Initial 02/04/2019 10:38:47 AM C Norm Norm 8 3.0 3.63 4.49 15.16 23.29 ------

02/04/2019 10:42:20 AM C Norm Norm 8 3.0 3.64 4.49 15.20 23.32 0.03 0.03

02/04/2019 10:43:42 AM C Norm Norm 8 3.0 3.63 4.49 15.16 23.28 -0.04 -0.01

02/04/2019 10:45:05 AM C Norm Norm 8 3.0 3.43 4.41 15.24 23.08 -0.20 -0.21

OS Average Measurements (mm) 4 Files Scan Lens Vitreous Change from Scan Date Ct. Rank ACD LT VCD AXL Type Type Type Prev Initial 02/04/2019 10:39:38 AM C Cat Norm 8 3.0 3.50 3.98 15.46 22.94 ------

02/04/2019 10:42:59 AM C Norm Norm 8 3.0 3.55 4.60 15.25 23.39 0.45 0.45

02/04/2019 10:44:02 AM C Norm Norm 8 3.0 3.55 4.51 15.23 23.30 -0.09 0.36

02/04/2019 10:45:29 AM C Norm Norm 8 3.0 3.57 4.53 15.22 23.32 0.02 0.38

Signature

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Robotics in Surgery Robotics in Perimetry Report Date: 02/25/2019 Page 1 of 1 Software Version 4.2.1

• da Vinci is the first surgical system • Patients were very receptive approved by the U.S. FDA for minimally • Twenty-two adults, naïve to perimetry, invasive general surgery in 2000 participated in four visual field tests • Increasingly becoming standard equipment conducted using an Octopus 900 (Haag- in many operating rooms Streit AG) controlled with the Open • Temple University presented the potential Perimetry Interface to enable automated use of the da Vinci robot in transscleral, feedback. subretinal injections • All participants received an initial • No tremor, reduction in incidence of RD93 introduction to perimetry from a human94

Robotics in Perimetry Robotics in Perimetry

• All participants received an initial • Post-hoc testing revealed no difference in introduction to perimetry from a human overall rating of experience between the operator and then participated with the human and the robot following feedback conditions: • But both were preferred to the computer – human speaker – humanoid robot (NAO Robot, Softbank Robotics, Japan) – computer speaker

95 96 VMax PSF Technology VASR Technology

VMax Technology VMax Technology

• Based on point spread function (PSF) rather • VMax Technology than Snellen recognition • Subjective focus • Measures down to 0.05D • Statistical increase in VA in pilot study • Spectacles developed to match the technology

PSF Refraction is More Sensitive Study from SCO

PSF Refraction is More Sensitive • VASR stands for voice activated subjective refraction • The scientific evidence showed that it was equally or more accurate to that of an eye doctor’s manual reaction in 97% of the cases • Drs. Christopher Lievens, Christina Newman, Alan Kabat, and a second year optometry student (Jacob Weber) • The results revealed that there was no statistically significant difference between Vmax VASR and the manual phoropter refractions.

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Study from SCO • 14% of patients had better acuity with the VASR System (> 1 Preferred by Patients line Snellen compared to the phoropter refraction), 3% of subjects had worse acuity with VASR (>1 line Snellen worse refraction), and 83% had less than 1 line Snellen line • A comparative study of 13 patients (26 difference compared to a faculty physicians traditional eyes), refracting patients first with a standard phoropter, refraction. and then using a PSF (point spread function) Refractor • The student had only 2 hours of training compared to decades of training from SCO faculty • 69% of patients achieved higher VA with the PSF • The VASR autorefraction system utilizes wavefront Refractor aberrometry and the subjective refraction component utilizes • 31% of patients achieved equal VA with the PSF Refractor proprietary point spread function (PSF) technology • 0% of patients achieved worse VA with the PSF Refractor • 20-30 seconds quicker with manual refraction*** • Submitted to IOVS for publication under Kabat A. et al 105 106

Quark NAION study QRK207

A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

107 108 Study Design Purpose of the study • This is a double masked, randomized, sham-controlled • Determine the effect of QPI-1007 on visual function in efficacy and safety study that will enroll approximately 530 subjects with recent-onset NAION. subjects with recent-onset NAION. • Subjects will be randomized into one of 5 groups in a • Assess the safety and tolerability of intravitreal injections 1:1:1:1:1 ratio, and assigned to receive QPI-1007 and/or a of QPI-1007 in this population. sham procedure. Subjects will have a one in five (20%) • Evaluate the structural changes in the retina following chance of receiving sham procedure (no active treatment). administration of QPI-1007. • 5 cohorts: single low dose injection, single high dose injection, multiple low dose injections, multiple high dose injections, and sham injection procedure. • Total study time involvement is approximately 12 months.

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Key Inclusion Criteria Drug Delivery Advances

• Males and females 50-80 years old • Positive diagnosis of first episode of NAION in the study eye with symptom onset within 14 days prior to planned study drug administration/sham procedure • Clear ocular media and able to undergo adequate dilation to allow a good fundus examination

• Go to www.EyeActNow.com for current sites

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Drug Delivery Advances Ocular Therapeutix Drug Deliver

• Dextenza post cataract • Dextenza for allergic • Sustained release Travoprost • Dry eye therapy via a punctal plug

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Mati Therapeutics Punctal Plug EyeGate Technology Drug Deliver Iontophoresis

• Evolute • 94% retention rates in clinical study • Statistical improvement in inflammation and pain following cataract surgery with only an NSAID within the plug

119 120 EyeGate Ocular Bandage Lens EyeGate Ocular Bandage Lens

• In a recent PRK clinical trial • 45 subjects and 3 arms • OBG vs. BCL vs. Control (AT’s and ungs)

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EyeGate Ocular Bandage Lens SIMPLE DROPS

▪ Offers a preservative-free treatment regimen for your patients ▪ Provides convenience of multiple medications into one combination drop ▪ May increase patient compliance by reducing the number of drops taken per day ▪ May reduce costs to your patients with a low monthly 123 cost

PRESERVATIVE-FREE DROPS

All Simple Drops compounded formulations are made preservative-free. ▪ Products with preservatives may cause adverse reactions such as superficial punctate , corneal erosion, and conjunctival allergy4,5 GLAUCOMA FORMULATIONS ▪ Discomfort associated with adverse symptoms can lead to decreased compliance and/or discontinuation of treatment5 ▪ Reducing the exposure to preservatives involves reducing the number of drops and/or removing the preservatives completely

4. Inoue, K. Managing adverse effects of glaucoma medications. Clinical Ophthalmology 2014; 8: 903-913. 5. Bagnis, A, Papadia, M, Scotto, R, Traverso, C. Antiglaucoma drugs: The role of preservative-free formulations. Saudi Journal of Ophthalmology 2011; 25(4): 389-394. SIMPLE DROPS COMPOUNDED MEDICATIONS FOR GLAUCOMA FORMULATIONS

Topical Offerings Size Latanoprost 0.005% PF 7.5mL • Duo Glaucoma Drop Dorzolamide 2% PF 10mL –Latanoprost and timolol Dorzolamide 2%/Timolol 0.5% 10mLmL • Triple Glaucoma Drop Timolol 0.5%/Latanoprost 0.005% PF 5mL –Timolol, bromonidine and dorzolamide Brimonidine 0.15%/Dorzolamide 2% PF 10mL • Quad Glaucoma Drop Timolol 0.5%/Dorzolamide 2%/Latanoprost 5mL –Brimonidine, dorzolamide, latanoprost and 0.005% PF timolol Timolol 0.5%/Brimonidine 0.15%/Dorzolamide 2% 10mL PF Timolol 0.5%/Brimonidine 0.15%/Dorzolamide 2%/ 5mL Latanoprost 0.005% PF 128

NEW TOTAL TEARS OFFERINGS FOR DRY EYE

Topical Offerings Size Klarity-C (Chondroitin sulfate/cyclosporine 0.1% 5.5mL DRY EYE FORMULATIONS ophthalmic bottles emulsion PF) Klarity (Chondroitin sulfate ophthalmic solution PF) 10mL bottles

BENEFITS OF CHONDROITIN SULFATE KLARITY BASE

▪ Enhances patient comfort associated with surgical trauma, contacts, and dry Apple-like eye ▪ Provides as a lubricant to the ocular surface1 companies ▪ Contains Chondroitin Sulfate, known to preserve the cornea ▪ Shown to have anti-inflammatory effects1,2

1. Moon W A, Lee H, Shin K C, et al. Short term effects of topical cyclosporine and viscoelastic on the ocular surfaces in patients with dry eye. Korean Journal of Ophthalmology 2007; 21(4);pgs189-194. 2. Llamas-Moreno J F, Baiza-Duran L M, Saucedo-Rodriguez L R, et al. Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/ propylene glycol/hydroxypropyl guar in patients with dry eye. Clinical Ophthalmology 2013; 7;pgs995-999. 134

RETeval: Hand-held Portable non- mydriatic Full-Field ERG + VEP

Quick Facts • The first, and only FDA cleared, hand-held, mobile, non-mydriatic Full-Field ERG device • Affordable ERG testing in the palm of your hand • Easily integrates into your current practice flow • No dedicated test room or additional staff required • OF RETEVAL IN USE RETeval® Hand-Held, Full-

135 Field ERG 136

Quick Facts EyeKineti • Complementary to other X tests of function like visual fields and cone- isolation contrast sensitivity (ColorDx) • Largely unaffected by cataracts • May be useful for following progression of disease (e.g. diabetes) • Normative database for easy, color coded interpretation of most RETeval® protocols

Hand-Held, Full-

Field ERG 137 Pupil diagnostics Quick Facts have just been transformed • Objective, quick, portable pupillary from the dark ages light reflex testing to the 21st Century (PLR/RAPD) • Modern, accurate alternative to the century old swinging flashlight test EyeKinetix® • Confidently examine Pupillographer your dilated patient knowing a possible (Coming Soon) RAPD has not been missed 139

Test: Full Field Stimuli

Analog of Swinging Flashlight

Expanded Stimuli

Normal, typical, Abnormal, matching diferential latency responses Results ColorDx • Substantially more detailed than the best human observers – Clinicians typically only are reporting gross RAPD • Uses cone isolation contrast testing defects • Individual Landolt C’s that stimulate the 3 – Clinicians cannot see or judge pupil latency or velocities cone receptors – Simplified assessment of dark patients and • Extremely accurate • Ideal for early pathology detection such as “The reason that eye doctors don’t do glaucoma RAPD testing is that it is too difcult.”

R. Susanna, 2009, President World Glaucoma Association, 2007 146

The Device

ColorDx Expanded Validated by Naval Aerospace Medical Institue

Used to qualify military aviators Recommended for approval for the FAA

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Color Deficiency Color Deficiency

• Affects 1 in 200 females • Affects 1 in 8 males • 30 Million Americans have some level of color deficiency • Deuteranopia being most common • Protanopia occurs more often with acquired disease • Ishihara misses 100% of protanopia 149 150 HUE.AI Enchroma • Clear lenses • AI helps ensure ‘actual’ color potential • Indoor and outdoor lens

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Color Deficiency Enchroma

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THANK YOU!

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