Current Surgery Tools Unable to Support Future Expectations. Current Percentage of Eyes Within 0.50D of Intended Vision Outcome

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Phebe Hudson
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$ORA (Optiwave Refractive Analysis Current Surgery Tools Unable$ Within 0.

request secondary enhancement surgery Surgeons bear cost of

procedure profit by up to 50% Patients paying out-of-pocket

3 ORA (Optiwave Refractive Analysis Current Surgery Tools Unable to Support Future Expectations Current Percentage of Eyes Within 0.50D of Intended Vision Outcome Historical IOL power formulas have modest success, ~50% within 0.5 diopter (D) >40% of patients dissatisfied: need glasses or request secondary enhancement surgery Surgeons bear cost of post-surgery enhancement procedures, which can reduce procedure profit by up to 50% Patients paying out-of-pocket for premium lenses expect spectaclefree, LASIK-like results Surgeons need refractive measurement when it matters most intra-operatively Copyright 2011 WaveTec Vision

An intralamellar water impermeable membrane is a barrier to gradient flow of water and nutrients

The nutrient gradient is created by the tissue metabolism.

has no power Inlay provides an unobstructed pathway for focused light to reach the retina Inlay

8mm Diameter 8,400 holes (5-11 μm) 5 μm thick Made from Polyvinylidene Fluoride (PVDF) Inlay in

5 An intralamellar water impermeable membrane is a barrier to gradient flow of water and nutrients across the cornea. The water gradient is created by evaporation from the tear film. The nutrient gradient is created by the tissue metabolism. Inlay improves vision by extending depth-of-focus Central aperture is a hole in the inlay and has no power Inlay provides an unobstructed pathway for focused light to reach the retina Inlay Design 3.8mm Diameter 8,400 holes (5-11 μm) 5 μm thick Made from Polyvinylidene Fluoride (PVDF) Inlay in vivo Image courtesy of Dr. Minoru Tomita Shinagawa LASIK Center OQAS Depth of Focus (D): 0.25 Subjective assessment with the OQAS device shows this eye has only 0.25D of depth of focus. Optical Quality Analysis System - Visiometrics (Spain)

6 Without Inlay: SLR camera simulation of vision with a 4.0 mm pupil feet, f-stop 5.6 With Inlay: SLR camera simulation of vision with a 1.6 mm pupil feet, f-stop 22 Subjective assessment with the OQAS device shows the eye with the inlay has >2.50D of depth of focus. Optical Quality Analysis System - Visiometrics (Spain)

Surgical Procedures Pocket Emmetropic KAMRA (PEK) Epithelium Post-LASIK KAMRA (PLK) and Planned LASIK KAMRA 2 Step Epithelium (PLK2) 100μm Pocket Pocket LASIK Flap Endothelium Endothelium

7 Surgical Procedures Pocket Emmetropic KAMRA (PEK) Epithelium Post-LASIK KAMRA (PLK) and Planned LASIK KAMRA 2 Step Epithelium (PLK2) 100μm Pocket Pocket LASIK Flap Endothelium Endothelium Description: A pocket is created in the stroma at a depth of μm. The inlay is then inserted in the pocket. Suitable for: Emmetropic Presbyopes (Naturally occurring or pseudophakic) Description: A LASIK treatment is performed under a 100μm flap. A minimum of one month later, a pocket is created 100μm under the LASIK interface, and the inlay is inserted into the pocket. Suitable for: Ametropic presbyopes Post-LASIK presbyopes

8 There is a small reduction in photopic and mesopic contrast sensitivity however scores remains within normal limits at 24 months post-op. Ultimately the reduction is minor when compared to the benefits of the inlay ** Pre N = M N = M N = 442 *Data on file at AcuFocus *Data on file at AcuFocus Pre N = M N = M N = 442 *

Long-Term Results: Uncorrected Near VA at 5 Years UCNVA improved from a mean of J8 to J2 in

Vision in the inlay eye and with both eyes (BE) is unaffected by the progression of

UCNVA in the untreated other eye (OE) shows an mean loss of 1 line over the same time period.

Undetectable In social circumstances the inlay is virtually undetectable even in light

9 Long-Term Results: Uncorrected Near VA at 5 Years UCNVA improved from a mean of J8 to J2 in the inlay eye (IE) between preop and 1 month. This result is maintained out to 5 years. Vision in the inlay eye and with both eyes (BE) is unaffected by the progression of presbyopia. UCNVA in the untreated other eye (OE) shows an mean loss of 1 line over the same time period. ETDRS letters UCNVA Month IE OU Mean Loss* Virtually Undetectable In social circumstances the inlay is virtually undetectable even in light colored eyes The inlay is only visible: Bright light conditions either from: An oblique angle up close, or Straight on if the fellow eye pupil is smaller than 3.8mm Data courtesy of Günther Grabner, MD

11 Pre-Op: Inlay Eye 36 Mo Post-Op: Inlay Eye 1 - US IDE Clinical Trial 2 Sanchez et al, ARVO Brooker et al, ARVO 2013

(dominant eye) may be emmetropic or ametropic For ametropic

12 SC-018 Rev A Implantation Strategy The KAMRA Inlay is implanted MONOCULARLY in the NON-DOMINANT eye The fellow eye (dominant eye) may be emmetropic or ametropic For ametropic eyes a LASIK procedure can be performed on the same day as inlay implantation

Bioengineering of the Eye Hysteresis: Not a New Concept 1. Glass DH et al. Invest Ophthalmol Vis Sci. 2008;49:3919-3926. 2. Taylor DA et al. Corneal Biomechanics.

Vincent J. Basic elasticity and viscoelasticity. In: Vincent J, ed. Structural Biomaterials. 3rd ed. Princeton, NJ: Princeton University Press; 20

$On the biomechanical properties of the cornea with particular reference to refractive surgery. Acta Ophthalmol Scand Suppl. 1998;(225):1-23.$

15 Bioengineering of the Eye Hysteresis: Not a New Concept 1. Glass DH et al. Invest Ophthalmol Vis Sci. 2008;49: Taylor DA et al. Corneal Biomechanics. In: Copeland RA Jr., Afshari NA, eds.: Copeland and Afshari s Principles and Practice of Cornea. Two Volume Cornea Textbook. Jaypee Brothers. 2012: Vincent J. Basic elasticity and viscoelasticity. In: Vincent J, ed. Structural Biomaterials. 3rd ed. Princeton, NJ: Princeton University Press; 2012: PubMed Search for hysteresis on October 3, 2014 returned 7696 results. 3. Hjortdal JO1. On the biomechanical properties of the cornea with particular reference to refractive surgery. Acta Ophthalmol Scand Suppl. 1998;(225):1-23. CH is an Indicator of Progression David Luce, PhD Invented the concept of Corneal Hysteresis 1. Luce DA. J Cataract Refract Surg. 2005;31: Dupps WJ Jr. J Cataract Refract Surg. 2007;33: Glass DH et al. Invest Ophthalmol Vis Sci. 2008;49:

2001 OHTS publication the largest and longest glaucoma study in history CCT was the strongest independent indicator

glaucoma risk assessment Not as an IOP correction factor Low,Medium,High stratification system 1. Pensyl D et al.

CH and the structural continuum CCT=central corneal thickness; IOP Intraocular Pressure 1 Deol M, Taylor DA,

16 2001 OHTS publication the largest and longest glaucoma study in history CCT was the strongest independent indicator of conversion from ocular hypertension to POAG in the OHTS 1,2 As a result, CCT has become an essential metric in glaucoma risk assessment Not as an IOP correction factor Low,Medium,High stratification system 1. Pensyl D et al. Eye (Lond). 2012;26: Gordon MO et al. Arch Ophthalmol. 2002;120: CH and the structural continuum CCT=central corneal thickness; IOP Intraocular Pressure 1 Deol M, Taylor DA, Radcliffe NM. Corneal hysteresis and its relevance to glaucoma. Curr Opin Ophthalmol Jan Method of operation IR Light Emitter te IR Light Detector

17 Method of operation CCT 455 CH 11.2 CRF 10.8 CCT 605 CH 11.3 CRF 10.7 Thin Cornea with no ectasia CCT 500 CH 8.1 CRF 7.9 CCT 597 CH 8.4 CRF 7.2 Thin Cornea with Keratoconus Define & Describe IOPcc Corneal-Compensated Intraocular Pressure The Cornea, IOP, and Glaucoma

18 57 yo post LASIK female Complaining of blurry vision and pain in right eye GAT: 15 mmhg IOPcc: 46 mmhg!! OCT image showed fluid under the flap Data Courtesy of William Wiley, MD Cleveland Clinic 10 4

19 MIGS Minimally Invasive Glaucoma Surgery

20 gonioscopy What is Dry Eye Disease? DEWS Report, Ocular Surface April 2007 Vol 5 No 2

Inflammation, Cell Damage and Symptoms in

Meniscus Height 33% Source: DEWS Report,

21 Tear Hyperosmolarity- the Central Mechanism Causing Ocular Surface Inflammation, Cell Damage and Symptoms in Dry Eye Disease DEWS Report, 2007 Clinical Test PPV Osmolarity 87% Schirmers 31% TBUT 25% Staining 31% Meniscus Height 33% Source: DEWS Report, Ocular Surface April 2007 Vol 5 No 2, & Tomlinson A, et. al., IOVS 47(10) 2006

22 Osmolarity (mosmol/l) before 15 min 45 min 60 min 90 min 120 min before 15 min 45 min 60 min 90 min 120 min Sub A Sub B Sub C

23 PreOp 1 Day PostOp 1 Week Post Op 1 Month PostOp Montani ni Giancarlo a Optometrist FIACLE, Dept di Optometria, Università del Salento

PROKERA : History 2005 Launched as Class II Medical Device 2011 - New CPT Code (65778) available to Opthalmologists 2013 - PROKERA used in over 15,000 patient uses 2013 Introduced PROKERA to

24 PROKERA : History 2005 Launched as Class II Medical Device New CPT Code (65778) available to Opthalmologists PROKERA used in over 15,000 patient uses 2013 Introduced PROKERA to Optometry Launched two new products as line extensions: PROKERA SLIM & PROKERA PLUS Mild to Moderate Moderate to Severe Severe Inflammation Inflammation Inflammation PROKERA utilizes the proprietary CryoTek cryopreservation process that maintains the active extracellular matrix of the amniotic membrane (AM) which uniquely allows for regenerative healing PROKERA is the ONLY FDA-cleared therapeutic device that both reduces inflammation and promotes scar less healing PROKERA can be used for a wide number of ocular surface diseases with severity ranging from mild, moderate, to severe PROKERA : BIOLOGIC CORNEAL BANDAGE PROKERA SLIM Incorporates New ComfortRING Technology for an optimal patient experience Slim profile designed to contour to the ocular surface Elegantly designed to move with the eye Maximizes amniotic membrane contact with the cornea, limbus, and limbal stem cells

PROKERA PLUS Recommended Pre-Treatment Tips For

chemical burns The Classic Ring acts as a

Multiple layers of tissue results in additional

maintain prolonged biologic action and durability,

ocular surface Rinse PROKERA with saline to prevent

may be used while the PROKERA is place (PRN) PROKERA

25 PROKERA PLUS Recommended Pre-Treatment Tips For severe cases such as Stevens Johnson Syndrome and chemical burns The Classic Ring acts as a symblepheron ring to maintain the orbital space Multiple layers of tissue results in additional therapeutic function by staying on the eye longer to maintain prolonged biologic action and durability, reduce inflammation and promote healing on the ocular surface Rinse PROKERA with saline to prevent stinging from preservation media Topical medications may be used while the PROKERA is place (PRN) PROKERA is easily inserted in the office Temporary Tarsorrhaphy (PRN) tape tegaderm nasal strips

Clinical experience of 9,000 small aperture Inlays for presbyopia correction

Clinical experience of 9,000 small aperture Inlays for presbyopia correction Minoru Tomita, MD, PhD Shinagawa LASIK Center, Tokyo, Japan September 7 th, 2012, ISOP meeting in Tokyo, JAPAN 1,060,666 Femto