Financial Disclosure. Acufocus. Presbyopia Surgery. Inlay Concept 8/14/17. Presbyopia Correction: The Holy Grail of Ophthalmology

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1 Acufocus Financial Disclosure I have no financial interest in any subject presented Presbyopia Correction: The Holy Grail of Ophthalmology Presbyopia Surgery Inlay Concept First conceived in 1949 by Dr. Jose Barraquer Primary advantages: Tissue-sparing Removable Primary design challenges: Effective optics Biocompatibility with the cornea Stable and predictable results 3 Major Categories of Available Inlays Refractive Corneal Inlays Corneal shape-altering inlays Small-aperture inlays 1

2 These disc shaped corneal implants work by changing the refractive index of the cornea. The central zone of the implant is neutral or plano, and has no refractive power. It allows light rays from distant source to focus on the retina, preserving distance vision. The central neutral zone is surrounded by one circular zone of additional positive power, which focus light rays from near objects on the retina, and improve near vision. Their design is similar to multifocal contact lens or intraocular lens. Refractive Inlays Presbia Flexivue Microlens TM The Presbia Flexivue Microlens TM (Presbia, Irvine, California, USA)is a transparent hydrogel implant (made of hydroxyethyl methacrylate and methyl methacrylate) with a diameter of 3 mm. It has a central plano zone, surrounded by multiple rings of progressively increasing powers from to D, creating a multifocal effect. The lens is microns thick from the center to its periphery. It is placed in a stromal pocket May be exchanged for higher add power as patients age At present, it is in FDA trials in the US. Presbia Corneal shape-changing inlays These corneal implants are designed to change the curvature of the anterior corneal surface. They are placed anteriorly in the cornea, either under a microns flap, or in a stromal pocket, to create a hyperprolate anterior corneal surface. They correct presbyopia by increasing the curvature of the central part of the anterior corneal surface. Paracentral light rays,travel through the thinner portion of the inlay and enable viewing distant objects while near objects can be viewed clearly through the central curved part of the cornea. The Raindrop Near Vision Inlay, Mechanism of Action formerly known as the PresbyLens or Vue+ lens(revision Optics, Lake Forest, California, USA) is a thin transparent permeable hydrogel implant. It is 1.5-2mm in diameter and varies in thickness from 10 microns in the periphery to 32 microns in the center. Its refractive index and water content are similar to those of the cornea. It has no additional refractive power. Being permeable, it allows transmission of nutrients through it. It is commercially available in the European Union. 2

3 Simple Surgical Procedure At All Distances Binocular Means at 1 Year Near Intermediate Distance Mean Visual Acuity in Snellen / / Mean Visual Acuity in logmar 20/6325 N = 373 PRE 1W 1M 3M 6M 9M 12M s Gain +5 Lines of Near 92% Subject Satisfaction Mean Change in Lines of Acuity Near Intermediate Distance Distance (BINOC) * Error bars represent 95% confidence intervals 6M-PRE 9M-PRE 12M-PRE 1W-PRE 1M-PRE 3M-PRE Preoperative Satisfaction with Current Near Vision Correction 34% 66% 12 Months Postoperative Satisfaction with Raindrop Vision 8% 92% Mean change in acuity: Near, Intermediate, -1.0 Monocular Distance Somewhat, Very, or Completely Satisfied Somewhat, Very, or Completely Dissatisfied 3

4 3% Explant Rate at 1 Year Of 340 Subjects, 11 were Explanted Reasons for Explantation 2 - Misalignment 2 Epi in-growth 1 - Recurrent haze that did not respond to treatment 1 - Visual symptoms 5 Dissatisfaction Most Patients Return to Preop Acuities by 3 Months were or better CDVA within 2 lines of preoperative CDVA 89% were or better UDVA 89% within 2 lines of preoperative UDVA 18 Inlay Exchanges Occurred in the first days after surgery, up to 3 months 17 of the subjects' visual outcomes were similar to non-exchanged subjects Small Aperture Inlays These inlays are opaque, ring shaped with a central aperture. Based on the principle of pinhole optics, they improve near vision by increasing the depth of focus. The ring blocks the peripheral light rays and allows only the central rays to pass unhindered. KAMRA Inlay Design Inlay improves near 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 8,400 holes (5-11 μm) 3.8mm Diameter 1.6mm Aperture 6 μm thick Made from Polyvinylidene Difluoride (PVDF) Inlay in vivo Image courtesy of Dr. Minoru Tomita Shinagawa LASIK Center KAMRA Milestones Small Aperture Inlay Evolution Over 15,000 inlays implanted worldwide 6 years of follow-up U.S. FDA Approved April 2015 Available in 45 countries Canada Europe Asia-Pacific Middle East South America 4

5 Permeability Distance, Intermediate and Near Visual Acuities: Implanted Eyes 8,400 micro-perforations (5-11 μm) An average 3 line gain at 12 months was achieved and sustained over the duration of the study Achieved results remain stable over the 36 month follow-up Pseudo-random pattern Maximize nutrient flow Minimize visual symptoms Visual Acuity (ETDRS Letters) 20/32 20/40 20/63 US IDE Patients N= Uncorrected Visual Acuity in the KAMRA Inlay Eye Change between Pre-Op and 36 Months: Mean UCNVA improved 5 lines from J8 to J2 Mean UCDVA reduction from 20/18.5 to Mean MRSE changed from D to D KAMRA Inlay US Commercial Experience FDA approval received April 17, ,300+ implanted in the US in 6 months Early commercial results are the same or better than the US IDE clinical trial results for both near and distance visual acuity UCNVA - OU 95% 95% 86% 80% UCDVA - OU 99% 94% 94% 87% 80% 63% 67% 66% 80% 60% 40% 41% 39% 40% 60% 40% 20% 20% 0% or better or better 20/32 or better 20/40 or better 0% or better or better 20/32 or better 20/40 or better 1 Month 3 Months 3 Year - IDE Trial 1 Month 3 Months 3 Year - IDE Trial *N=153 at 36 months, < 6x6 group, data on file at AcuFocus Depth-of-Focus and Post-op UCDVA in the Inlay Eye US Commercial Outcomes 0.25D of depth of focus Several Months Post-op 2.50D of depth of focus As expected, distance vision in the inlay eye is reduce by about 1 line UCDVA remains essentially unchanged across all exam dates 1.20 UCDVA - Inlay Eye 1.40 UCDVA - OU AcuTarget HD Instrurment (N=636) Week 1 (N=508) Month 1 (N=374) Month 3 (N=219) (N=53) 0.00 (N=526) Month 1 Month 3 (N=336) (N=200) (N=52) 5

6 1.2 UCNVA in the Inlay Eye US Commercial Outcomes Near vision improves by 3.5 lines by one month, this gain is maintained out to 6 months Mean inlay eye and binocular UCNVA is J2 at 6 months UCNVA - Inlay Eye 1.20 UCNVA - OU 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 (OU) 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 (N=588) Week 1 (N=496) Month 1 (N=270) Month 3 (N=218) (N=53) (N=504) Month 1 (N=344) Month 3 (N=196) (N=52) ETDRS letters UCNVA Month IE OU Data courtesy of Günther Grabner, MD Finding the Sweet Spot 92% of patients achieved a UCDVA and J3 UCNVA with post op MRSE to Visual Recovery Similarities to both PRK and Monovision Patience! Neuroadaptation 3-6 mos Dim vision improves over 2-4 weeks Mild halo and glare at night common Loss of sharpness in dim light normal Encourage patient to avoid reading glasses Steroid and Dry Eye regimen very important Differences between EU and US experience Flap vs. Pocket -?better centration, less hyperopic shift? No centration devices (AcuTarget HD, itrace) Patient selection? AcuTarget HD assists in identifying patients with lens changes and poor tear film KAMRA Important that this is NOT monovision as distance acuity in the implanted eye is maintained In addition, monovision erodes over time as presbyopia progresses KAMRA may provide a lifetime of near vision even after cataract surgery 6

7 Achieving Success with Inlays Patient Selection: to with KAMRA No lens changes, good tear film Meticulous surgery Ensuring proper expectations Use of steroids, lubricants Thank You for Your Attention! 7