Using New Technologies in Your Contact Lens. Using New Technologies in Your Contact Lens. PureVision Is Back!!!! Acknowledgments

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1 Using New Technologies in Your Contact Lens Clarke D. Newman, OD, FAAO Northeast Texas Optometric Society Wednesday, June 15, 2005 Professional Lecture Series Using New Technologies in Your Contact Lens Clarke D. Newman, OD, FAAO Northeast Texas Optometric Society Wednesday, June 15, 2005 PureVision Is Back!!!! Professional Lecture Series Acknowledgments This program is a distillation of sixteen hours of educational material prepared for Bausch & Lomb University by the following people: Mohinder M. Merchea, OD, PhD (Manager, Refractive Technologies, Scientific & Clinical Affairs, Bausch & Lomb, Rochester, NY) Thomas Hobbs, OD (President, InSight EyeCare and NewVision Laser Center LLC, Warrensburg, MO) Michael DePaolis OD, FAAO (Clinical Associate Faculty, University of Rochester School of Medicine, Rochester, NY) Christopher Snyder, OD, MS (Professor of Optometry, Chief, Cornea and Contact Lens Service, University of Alabama, Birmingham School of Optometry, Birmingham, AL) Paul Karpecki, OD, FAAO (Director of Research, Moise Eye Center, Kansas City, KS)

2 History Silicone Hydrogel Lens Technology First launched in 1999 by Bausch and Lomb as PureVision, the most innovative lens for extended wear Shortly after the introduction, it was removed from the US market Late in 2004, B&L announced that the technology would again be available in April, 2005 Since then, there have been additional introductions of similar Si-Hy elastomers to the market and several studies on the technology relating to visual performance, patient outcomes and practice management Material Technology Silicone Promotes best oxygen transfer to the cornea (Dk/t) Reduces corneal swelling in both daily & overnight wear Minimal dehydration Hydrogel Good fluid transfer to cornea Excellent lens/cornea compatibility because of low elastic recovery Superior comfort because of low modulus (less stiffness) The Goals Overnight Swelling Blending Silicone and Hydrogel in the right proportions: No Lens PureVision Conventional Hydrogels Virtually eliminates lens induced hypoxia Radically reduces dehydration Silflex 77% 7% Provides excellent wetting characteristics Reduces protein deposits Enhances on- eye comfort 2% % Corneal Swelling SiHyS equivalent to no-lens wear & silicone elastomer lens Bacterial Binding Believed to be necessary for infection to occur Hypothetical relationship with hypoxia from contact lens wear Hrs 1 Month 3 Month Lidofilcon Etafilcon Polymacon Avg. Low Dk/t Hydrogels PureVision Safety Key Points from Graph Si-Hy Corneal swelling falls into the safe range, very close to that of no lens, or the natural state of the cornea Corneal swelling with pure silicone (Dk = 360) yields no better safety profile than that of most silicone hydrogel lenses Conventional hydrogels fall in the caution/ danger range Si-Hy lenses produce no more bacterial uptake than no lens at all over a 1-month period Q: What does this mean? A: Balanced, blended Si-Hy is the best material to meet oxygen transmissibility requirements and minimizing adverse hypoxic effects.

3 Fluid Transport The correct mix of Si-Hy allows for good ionic (fluid) transport (hydrogel portion) which can be measured in terms of: Improved patient comfort Lowered modulus Favorable on eye lens compatibility Optimum lens movement Comfortable, healthy lens wear Improved oxygen transmissibility right amount of silicone Increased fluid transport right amount of hydrogel Optimum transparency of the lens right amount of chemistry Ideal material elasticity & modulus Balanced blend for compatibility Fewer protein/lipid deposits Surface treatments to discourage attraction Healthier epithelium Decreased propensity for bacterial adhesion The Proof c Comfort Less Dryness Less Redness Visual Acuity Insertion Ease Handling Overall Preference Patient Outcomes Overall Clinical Performance: (N=155, 7 day Continuous Wear) PureVision Conventional Fewer Complications: Patient Outcomes Decreased corneal swelling for reduced risk ocular complications. No statistically significant difference in overnight corneal swelling between wearing a silicone-hydrogel lens and no lens at all More oxygen transfer than conventional hydrogel lens material Low level of bacterial binding Less protein/lipid deposition in surface manipulated lenses Improved Comfort: Correct balance of oxygen and water to provide all day comfort while allowing safe and healthy wear Optical Aspects of Design ABERRATIONS Vision Performance: Advanced Wavefront Optical Imaging in Contact Lenses

4 Visual Aberrations Path of the Wavefront Subjectively perceived as a blurring or halo effect, particularly in low contrast situations like night driving, cloudy days, etc. Caused by an irregularity in the optical system of the eye (inherent) or introduced by an applied vision correction system (induced) Aberrations can affect the passage of waves of light through various ocular media (such as the cornea, lens, and other structures) of the eye. Inherent Aberrations Tears Cornea Aqueous Lens Vitreous Retina Induced Aberrations Spectacles Contact Lens Intra-Ocular Lenses Surgical Procedures -Lasik -Cataract The Perfect Eye Myopic Eye Incoming light Incoming light Planar wavefront Myopic wavefront Outgoing light Outgoing light Perfect versus Aberrated Eye The Aberrated Eye Perfect Eye Planar wavefront Spherical wavefront Aberrated Eye Aberrated wavefront Outgoing light Wavefront: Myopic with deformations To describe an optical system, it is sufficient to describe the outgoing light rays, which is described by the wavefront

5 Available Aberrometers The Zywave II Aberrometer Hartmann-Shack LadarWave WaveScan ZyWave (Alcon) (VISX) (B&L) Ray Tracing (Tscherning) Tracey System Schwind ORK Allegreto Wave Anylyzer Pupil camera WASCA (C.Z. Meditec) KR-9000 (Topcon) Optical Path Difference NIDEK OPD CCD Holographic Gratin Z View (Ophthonix) Eye Laser Wavefront sensor Hartmann-Shack Wavefront Sensor Hartmann-Shack Wavefront Sensor Lenslet Array CCD Array Spot Array Wave Aberration Lenslet Array CCD Array Spot Array Wave Aberration Parallel light beams generate equidistant focal points Non parallel light beams (aberrated wave) do not give equidistant focal points Perfect Eye Aberrated Eye Construction of Wavefront Aberration Point Spread Functions (PSF s) Shack-Hartmann Image Reconstructed Wavefront Piston Defocus Astigmatism Coma Triangular Astigmatism Spherical Aberration

6 Point Spread Functions (PSF s) Point Spread Functions (PSF s) Piston Astigmatism 30º Piston Astigmatism 30º Defocus Point Spread Functions (PSF s) Point Spread Functions (PSF s) Piston Astigmatism 30º Defocus Horizontal Coma Piston Astigmatism 30º Defocus Horizontal Coma Trefoil Point Spread Functions (PSF s) Convolutions Piston Astigmatism 30º Defocus Horizontal Coma + = E Trefoil Spherical Aberration

7 Zernike Pyramid Basic mathematical elements that allow reconstruction of the wavefront aberrations of the human eye Root Mean Square (RMS) Root Mean Square (RMS) Aberrated Wave Correct Wave Correct Wave Root Mean Square (RMS) Root Mean Square (RMS) Aberrated Wave Aberrated Wave Positive Value Positive Value Negative Value Correct Wave Correct Wave

8 Root Mean Square (RMS) Root Mean Square (RMS) Aberrated Wave Aberrated Wave Positive Value -0.5, -0.7, 0.6, 1.0, etc. Positive Value -0.5, -0.7, 0.6, 1.0, etc. 0.25, 0.49, 0.36, 1.0, etc. Negative Value Negative Value Correct Wave Correct Wave Root Mean Square (RMS) Root Mean Square (RMS) Aberrated Wave Aberrated Wave Positive Value -0.5, -0.7, 0.6, 1.0, etc. Positive Value -0.5, -0.7, 0.6, 1.0, etc. 0.25, 0.49, 0.36, 1.0, etc. 0.25, 0.49, 0.36, 1.0, etc. Negative Value 0.49 Negative Value 0.49 Correct Wave Correct Wave 0.65 Root Mean Square (RMS) Provides a numerical representation of the magnitude of an error Correlates roughly to Dioptric difference, i.e., a RMS of 0.5µ is roughly equivalent in image disruption to 0.50 D of defocus Since the Just Noticeable Difference (JND) of the human eye is roughly 0.50 D, then a significant RMS value is one step below that value, or 0.40µ Microns Population Aberrations Zernike Co-Efficients - Large Population Distribution Zernike Co-Efficients - Large Population Distribution Z4 Z4 8 Z5 8 Z5 Z6 6 Z6 6 Astigmatism Z7 Z7 4 4 Z8 Z8 2 Z9 2 Z9 Z10 Z Z11 Z11-2 Z12-2 Z12 Z13-4 Z13-4 Z14 Z14-6 Higher Order Aberrations -6 Z15 Z15 Z16-8 Z16-8 Z17 Z Z18 Z18-12 Z19-12 Z19 Defocus Z20-14 Z20-14 Z21 Z21

9 The Poor Man s Aberrometer The Poor Man s Aberrometer The Poor Man s Aberrometer The Poor Man s Aberrometer The Poor Man s Aberrometer The Poor Man s Aberrometer

10 Point Spread Functions (PSF s) Aberration and Vision Piston Astigmatism 30º Defocus Horizontal Coma In a typical normal eye, wavefront aberrations become more apparent as the pupil size increases Trefoil Spherical Aberration As pupil size approaches mm, one begins to realize which forms of higher- order aberrations have the most debilitating impact on vision Impact of Pupil Size on Aberrations Pupil Size and Aberration Low light image with higher order aberrations and large size Low light image with higher order aberrations and small pupil size 0.25 Mean Spherical Aberration Z Pupil aperture / mm Spherical Aberration Population Spherical Aberration Population Distribution of Spherical Aberration 78 n = Z4 0 - Spherical Aberration

11 Spherical Aberration Spherical aberration Spherical aberration is one of the most frequent types of higher-order aberrations seen in the population Spherical surfaces Comparison of 0.1microns of spherical aberration (over 6mm) -0.1um of SA Higher Order Zernike Co-Efficients - Large Population Higher Order Zernike Co-Efficients - Large Population Trefoil Triangular Astigmatism Triangular Astigmatism Spherical Aberration Spherical Aberration Coma Coma Z7 Z7 Z8 Z8 Z9 Z9 Z10 Z10 Z11 Z11 Z12 Z12 Z13 Z13 Z14 Z14 Z15 Z15 Z16 Z16 Z17 Z17 Z18 Z18 Z19 Z19 Z20 Z20 Z21 Z21 Aspheric surfaces No aberrations (diffraction limited) Improving Image Quality Spherical Aberration Optimization Spherical Aberration cannot be eliminated by a single lens but it can be minimized by the appropriate shaping of the surface of the lens. This can only be achieved by aspheric optics now present in only the latest contact lens design technology. By correcting spherical aberration, the retinal image quality is improved D -6.00D -5.00D -4.00D -3.00D -2.00D -1.00D LEVEL OF SPHERICAL ABERRATION OF CONTACT LENS WITH SPHERICAL SURFACES LEVEL OF POPULATION AVERAGE POSITIVE SPHERICAL ABERRATION SF< µm Spherical aberration +0.10µm 0 Power -0.10µm SF>1 LEVEL OF SPHERICAL ABERRATION TO THEORETICALLY OFFSET POPULATION AVERAGE (ASSUMING PERFECT LENS CENTRATION) -0.20µm Aspheric Surfaces: Optimize the Shape Factor Spherical Aberration Reduction of PureVision CONIC SECTIONS -Based on a population average of to Shape factor < 1 (radius flattens away from center) Shape factor > 1 (radius steepens away from center) Spherical Aberration - microns µ µ Simulated Retinal Image - Use of the right asphere for each power Shape factor = 1 (spherical) Pupil Size Significant reduction in positive spherical aberration compared to equivalent spectacle correction Positive spherical aberration reduced an average of.094 microns in 1.00 DS.

12 Spectacles Spherical Aberration Control Design 0.15 ums Sph. Abr. Spherical aberration accounts for much of the phenomenon known as night myopia. At low light levels, the pupil enlarges and allows more peripheral rays to enter the eye. The peripheral rays are focused anterior to the retina, rendering the eye relatively myopic in lower light levels ums Sph. Abr. Visual Performance Visual performance is a direct result of multiple advanced design principles: Adaptive optics designed to correct high order spherical aberration correction Individual shape factor calculations for different prescription powers to neutralize prevailing population error Innovative combination of silicone and hydrogel Minimal lens movement Producing stable visual results Moderate modulus Allows an appropriate amount of optical stiffness while maintaining flexibility Plasma surface treatment Creating a optimal optical surface for refracting light Practice Management Corrected wave front spherical aberration improves vision to achieve a closer comparison to the latest wavefront refractive surgery techniques. Allows your office to provide many patients similar visual correction as Lasik, but at a much lower cost. Prescribing silicone-hydrogel lenses to meet higher level patient vision correction effects keeps patients and profits in your practice. Less complications frees up more chair time to see more patients. Word of mouth referrals from happy, more satisfied patients expands and maintains your patient base! Practice Management Flexible/Extended/Continuous Wear Patients appreciate the ability to wake up and see clearly 89% of patients wish they could wake up and see more clearly Patients want the convenience 52 % of patients have said that their contact lens cleaning routine interfere with their life 90% of the patients preferred silicone-hydrogel lenses because they gave them the freedom to do more things 70% of contact lens wearers prefer lenses that can be left in overnight 28% of patients prefer daily wear contacts that are removed every night.

13 FDA Approved Indication ZYLET is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. A Novel Combination A Unique Design ZYLET contains Loteprednol etabonate 0.5% Tobramycin 0.3% ZYLET the first and only ester corticosteroid/ aminoglycoside antibiotic combination clinically available combines loteprednol etabonate and tobramycin, both with proven efficacy profiles ZYLET is indicated for steroid-responsive inflammatory ocular conditions where a bacterial infection, or a risk of bacterial ocular infection, exists ZYLET was designed with a corticosteroid component (loteprednol etabonate) that minimizes the potential for unwanted side effects, specifically elevations in intraocular pressure Ester Loteprednol Ester vs. Ketone Steroids Ketone Prednisolone Fluorometholone Dexamethasone Medrysone Rimexolone Corticosteroid/Antibiotic Ophthalmic Combination Products 4+ Million people in USA are treated annually with ophthalmic antiinflammatory and anti-infective combination products. No new NDA combination product introduction in this segment in over 15 years ( Alcon Tobradex NDA approval- 9/28/1988). TobraDex (dexamethasone and tobramycin) most widely used brand with approximately 2.7 million TRx s annually. Source: IMS Health-MAT Nov. 2004; FDA Orange Book

14 ... Power and Protection The Smart Combination ZYLET: Site-Active Corticosteroid Plus Broad-Spectrum Aminoglycoside ATTRIBUTES ZYLET TOBRADEX Anti-Inflammatory Efficacy Next Generation Ester Corticosteroid Broad Spectrum Antibiotic Efficacy Suitable for a Wide Range of Patients Rapid Onset of Action and Symptomatic Relief Soothing, Comfortable, Well Tolerated Formulation? Patient Convenience/Compliance Loteprednol Etabonate 0.5% Site-active corticosteroid Inhibits inflammatory response 4.3 times greater binding affinity to steroid receptors than dexamethasone FDA approved for external, internal and postoperative inflammation Tobramycin 0.3% Broad-spectrum aminoglycoside Inhibits bacterial protein synthesis Binds to bacterial ribosomes Proven Clinical Experience With Loteprednol Proven Clinical Experience With Tobramycin Site-active corticosteroid introduced mid-1998 in USA More FDA approved indications than any other ophthalmic corticosteroid post-operative inflammation, anterior uveitis, seasonal allergic conjunctivitis, giant papillary conjunctivitis..plus any other steroid responsive condition Excellent corneal penetration Superb record of safety Package insert and postmarketing surveillance confirms a real paradigm shift with regards to ocular corticosteroids Broad-spectrum aminoglycoside antibiotic with over 20 years of real world experience Active against both Gram-negative and Gram-positive ocular pathogens Binds to bacterial ribosomes, inhibiting protein synthesis Excellent corneal penetration Low serum concentrations with ocular administration Sporadic reports of bacterial resistance in ophthalmic literature Tobramycin: Efficacy Chart Common Tobramycin-Susceptible Bacterial Pathogens Staphylococci species Streptococci species Pseudomonas aeruginosa Escherichia coli Klebsiella pneumoniae Enterobacter aerogenes Proteus mirabilis Morganella morganii Proteus vulgaris (most strains) Haemophilus influenzae Haemophilus aegyptius Moraxella lacunata Acinetobacter calcoaceticus Neisseria (some species)

15 Tobramycin: No Impact on Loteprednol Etabonate Bioavailability Loteprednol: No Impact on Tobramycin Antimicrobial Activity Analysis of intent- to- treat population 1 Zylet was tested versus tobramycin ophthalmic solution, USP, 0.3% 20 test organisms were evaluated in vitro Zylet found to have equivalent antimicrobial activity as tobramycin alone 1. Data on file, Bausch & Lomb Pharmaceuticals, Inc; Data on file, Bausch & Lomb Pharmaceuticals, Inc; Loteprednol Etabonate: Intraocular Pressure Patients at risk of steroid-induced increased IOP 14 to 22 Million Steroid Responders 3 to 6 Million Ocular Hypertensives 2.5 Million Glaucoma Patients A significant difference in known steroid responders Dexamethasone: Intraocular Pressure Low incidence of significantly elevated IOP for all patients loteprednol etabonate prednisolone acetate placebo %of patients with elevated IOP (15/901)* (11/164) (3/583)

16 Loteprednol Etabonate Clinical Safety Studied in >2000 patients in 20 clinical studies Ocular Adverse Events: low incidence of IOP rise comparable to placebo only 15 (1.7%) of 901 patients treated 28 days or longer had an IOP rise >10mm Hg 11 of 15 patients with a clinically significant (>10mm Hg) IOP response were in GPC studies patients were allowed to wear lenses indicating possible reservoir effect of lenses ZYLET: A Unique Design Clinical Indications Use combination steroid/antibiotic products when: Steroid responsive condition exists, and 2) Superficial bacterial infection, or risk of infection, exists Patient A - Blepharitis Patient B Peripheral Infiltrate

17 Patient C Post Surgical Patient D Non- specific Conjunctivitis Summary - Zylet Safer than existing combinations Equally effective Questions/Answers... Power and Protection The Smart Combination Unsurpassed steroid efficacy Closing Thoughts Time-tested antibiotic efficacy Rapid onset of action and symptomatic relief Soothing, comfortable and well tolerated formulation Minimal risk of IOP rise Preferred combination for a wide range of patients including steroid responders, ocular hypertensives, and glaucoma patients.

18 Now Available Questions? the first and only ester corticosteroid/antibiotic combination ophthalmic product.... Power and Protection The Smart Combination Thank You! Thank You!