Lasik Xtra Clinical Data Overview. MA Rev A

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1 Lasik Xtra Clinical Data Overview

2 Table of Contents What is Lasik Xtra? Who is Lasik Xtra being performed on? How is Lasik Xtra performed? What data to support Lasik Xtra?

3 What is Lasik Xtra? Performed in conjunction with LASIK Rapid procedure with lower energy dose (2.7J) Supported with clinical evidence Growth engine for physician practices Approved in >50 Markets Worldwide

4 Who is Lasik Xtra being performed on? Patient criteria being used by international users: Hyperopic Patients Highly Myopic Patients Borderline Residual Bed Thickness Family History of Ectasia Young Patients All LASIK Patients

5 How is Lasik Xtra Performed? Avedro s KXL System LASIK procedure performed as usual. Flap still open following excimer laser ablation in the bed Apply VibeX Xtra riboflavin to the stromal bed after excimer laser ablation for 90 s soak After 90 seconds, stromal bed irrigated to remove VibeX Xtra and reposition the flap as usual Apply UVA illumination through the epithelium: 30mW/cm 2 for 90 Sec (2.7 J/cm 2 delivered) with Avedro s KXL System.

6 Lasik Xtra Key Clinical Benefits Re-strengthening of the cornea Increased stability in visual outcomes Increased accuracy of refractive correction Lower enhancement rate

7 Why choose Lasik Xtra? Re-strengthening of the cornea Increased stability in visual outcomes Increased accuracy of refractive correction Lower enhancement rate The potential to improve integrity after LASIK through corneal CXL may provide an opportunity to reduce Keratectasia in other at-risk populations. H. Ugur Celik, J Cataract Refract Surg 2012 Celik H, Alagoz N, Yildirim Y, Agca A, Marshall J, Demirok A, Yilmaz OF. Accelerated corneal crosslinking concurrent with laser in situ keratomileusis. J Cataract Refract Surg 2012 ; 38:

8 Corneal Strengthening without Refractive Change Math Modeling Simulation Cleveland Clinic Modeling shows: 2x IOP IOP 15MMHG IOP 30MMHG 15 mmhg 30 mmhg LASIK 270 µm 547 µm Lasik + Crosslinking 254 µm 516 µm Finite Element Model calculates the displacement in residual bed when intra-ocular pressure in doubled: Lasik Xtra has less displacement when IOP increased since cornea is stiffer. However, simulations demonstrate refractive equivalence. Less displacement PRE-OP LASIK LASIK + Cross-linking Seven I, Roy ASR, Dupps BJ, Cleveland Clinic Cole Eye Institute. Adjunct Collagen Crosslinking of Residual Stromal Bed in LASIK: Finite Element Analysis of Impact on Refractive Outcome and Surgically Induced Deformation, Presentation at: Association for Research in Vision and Ophthalmology; 2014May ; Seattle, Washington, USA.

9 Corneal Weakening after LASIK Scientific Data LASIK Alone: 40% % Corneal Weakening Due to Flap Creation * Weakens corneal biomechanics Corneal Cross Linking: Restores strength to corneas Reduces potential risks due to biomechanical compromise including refractive regression and corneal ectasia. Corneal Weakening Tensile Strength 30% 20% 10% 0% 80µm 140µm 160µm 180µm Flap Depth Control 30mW 5.4J 30mW 7.2J *Jaycock PD, Lobo L, Ibrahim J, Tyrer J, Marshall J. Interferometric technique to measure biomechanical changes in the cornea induced by refractive surgery. Journal of cataract and refractive surgery. 2005;31(1): Ojalvo S.R., Kamaev P., Friedman M., Sherr E., Muller D.,Avedro Inc., Papain Digestion Method for Analysis of Cross-linking in Corneal Flaps, Poster Presentation at: Association for Research in Vision and Ophthalmology; 2013 May 05-09, 2013; Seattle, Washington, USA.

10 Why choose Lasik Xtra? Re-strengthening of the cornea Increased stability in visual outcomes Increased accuracy of refractive correction Lower enhancement rate High myopic LASIK combined with prophylactic higher-fluence CXL (LASIK-Xtra) intervention seems to induce less postoperative epithelial increase in large myopic cases. This may be an indication of enhanced cornea stability and may reduce the incidence of future myopic regression and/or the potential for ectasia. John Kanellopoulos, Greece, Cornea May 2014 Kanellopoulos AJ, Asimellis G. Epithelial Remodeling After Femtosecond Laser-assisted High Myopic LASIK: Comparison of Stand-alone With LASIK Combined With Prophylactic High-fluence Cross-linking. Cornea May;33(5):463-9

11 Long-Term Stability of Refraction Lasik Xtra patients only changed 0.19D Improved stability in Hyperopic LASIK Patients at 2 Yrs vs. LASIK alone patients changed 0.72D Dr. John Kanellopoulos 2012 study published in Journal of Refractive Surgery: 34 patients with 68 eyes Two-year follow-up Pre-Op Lasik Xtra Mean: ± 1.46 D Pre-Op LASIK Mean: ± 1.78 D Range: to D Range: to D Kanellopoulos AJ, Asimellis G. Topography guided Hyperopic LASIK With and Without High Irradiance Collagen Cross linking: Initial Comparative Clinical Findings in a Contralateral Eye Study of 34 Consecutive Patients. Journal of Refractive Surgery Vol. 28, No. 11

12 Long-Term Stability of Refraction Lasik Xtra patients showed stable Uncorrected Distance Visual Acuity over one year follow up / / UDVA vs. Time (one year follow-up) UDVA (logmar/snellen) 20/320 Dr. Minoru Tomita s presentation at AAO 2013: 1 20/ /125 N = 601 LASIK Xtra patients Mean: ± 1.52 Diopter (D) Range: D to D 1 Year Follow up / / / / NS /12.5 PreOP (n=855) 1D (n=855) 1W 1M 3M (n=790) (n=748) (n=623) UDVA (logmar/snellen) 6M (n=464) 1Y (n=601) Tomita M, MD, PhD, LASIK Xtra in Clinical Practice, Presentation at: American Academy of Ophthalmology; 2013 Nov 16-19; New Orleans, USA.

13 Improve The Long-Term Stability of the Refraction Lasik Xtra patients showed no significant MRSE vs. Time (1through to 12 month(s) postop) changes in MRSE & average K reading over 12 mo follow-up. Dr. Minoru Tomita s study published in the J Cataract Refract Surg 2014: 1 Year Refractive Outcomes & Stability N=24 Lasik Xtra Px N=24 LASIK Px NS Lasik Xtra Px Mean: ± 2.18 (D) LASIK Px Mean: ± 2.21 (D) 1 Year Follow up Tomita M, Yoshida Y, Yamamoto Y, Mita M, Waring G.,In vivo confocal laser microscopy of morphologic changes after simultaneous LASIK and accelerated collagen crosslinking for myopia: One-year results. J Cataract Refract Surg 2014; 40: Q 2014 ASCRS and ESCRS

14 Why choose Lasik Xtra? Re-strengthening of the cornea Increased stability in visual outcomes Increased accuracy of refractive correction Lower enhancement rate Lasik Xtra with the crosslinking of the cornea reduces the change in corneal biomechanics and therefore reduces the scatter and standard deviation of the results. Dr Jerry Tan, Singapore

15 Greater Refractive Accuracy in High Myopic LASIK Patients Lasik Xtra patients showed less scatter and greater accuracy in their refractive change Lasik: Lasik Xtra: 65% of Px ± 0.5 D 90% of Px ± 0.5 D Dr. Jerry Tan s study presented at ESCRS 2013: N= LASIK only (49 eyes) vs Lasik Xtra (41 eyes) Singapore (66% Female & 34% Male) Mean :-8.82 ± 1.81 D Range : to D 3 month follow-up Tan J, Por Y. 1 year experience with corneal wavefront-guided LASIK with flash cross-linking (LASIK Xtra) for the treatment of high myopia patients (-8.00D to D) using the SCHWIND Amaris 750S laser: clinical outcomes. Paper presented at: XXXI Congress of the European Society of Cataract and Refractive Surgeons; 2013 Oct 5-9; Amsterdam, Netherlands.

16 Greater Refractive Accuracy in High Myopic LASIK Patients 65% vs 90% ± 0.5D High Myopia LASIK With and without Lasik XTRA (3 Month Data) LASIK only Achieved change in SEQ Refraction [D] overcorrected y = 0.00x x R² = eyes - 3 m postop mean 0.45 D (from 0.00 to 1.63) undercorrected Attempted change in SEQ Refraction [D] Jerry Tan Eye Surgery Achieved change in SEQ Refraction [D] LASIK with LASIK XTRA overcorrected y = -0.00x x R² = eyes - 3 m postop mean 0.19 D (from 0.00 to 0.50) undercorrected Attempted change in SEQ Refraction [D] Jerry Tan Eye Surgery Tan J, Por Y. 1 year experience with corneal wavefront-guided LASIK with flash cross-linking (LASIK Xtra) for the treatment of high myopia patients (-8.00D to D) using the SCHWIND Amaris 750S laser: clinical outcomes. Paper presented at: XXXI Congress of the European Society of Cataract and Refractive Surgeons; 2013 Oct 5-9; Amsterdam, Netherlands.

17 Greater Refractive Accuracy in High Myopic LASIK Patients High Myopia LASIK With and without Lasik XTRA (3 Month Data) 65% vs 90% ± 0.5D Lasik Xtra patients showed less scatter and greater predictability in their refractive change LASIK only Achieved change in SEQ Refraction [D] overcorrected y = 0.00x x R² = eyes - 3 m postop mean 0.45 D (from 0.00 to 1.63) 65% undercorrected Attempted change in SEQ Refraction [D] Jerry Tan Eye Surgery Achieved change in SEQ Refraction [D] LASIK with LASIK XTRA overcorrected y = -0.00x x R² = eyes - 3 m postop mean 0.19 D (from 0.00 to 0.50) 90% undercorrected Attempted change in SEQ Refraction [D] Jerry Tan Eye Surgery Tan J, Por Y. 1 year experience with corneal wavefront-guided LASIK with flash cross-linking (LASIK Xtra) for the treatment of high myopia patients (-8.00D to D) using the SCHWIND Amaris 750S laser: clinical outcomes. Paper presented at: XXXI Congress of the European Society of Cataract and Refractive Surgeons; 2013 Oct 5-9; Amsterdam, Netherlands.

18 Why choose Lasik Xtra? Re-strengthening of the cornea Increased stability in visual outcomes Increased accuracy of refractive correction Lower enhancement rate He also feels there is less regression occurring among Lasik Xtra cases a notorious occurrence among standard hyperopic LASIK cases. High Myopes also tend to experience significant regression after LASIK, but not with Lasik Xtra, Dr. Jerry Tan, Singapore, Eyeworld Asia-Pacific, 2013 March Jerry Tan, Strengthening corneas in Singapore. Eyeworld Asia Pacific March

19 Lasik Enhancement Rate Potential for significant savings on lower re-treatment rates for Lasik Xtra patients. 4 published studies 41,468 Eyes: Average retreatment rate of 12% Majority of which in the first 3 years post Lasik Number of Eyes Retreatment rate ¹Study % ²Study 2 37, % ³Study % 4 Study 4 2, % ¹Alió J.L., Muftuoglu O., Ortiz D., Pérez-Santonja J.J., Artola A., Ayala M.J., Garcia M.J., De Luna G.C. Ten-year Follow-up of Laser In Situ Keratomileusis for High Myopia. ELSEVIER INC 2008 ²Yuen L.H., Chan W.K, Koh J, Mehta J.S., Tan D.T. A 10-Year Prospective Audit of LASIK Outcomes for Myopia in Eyes at a Single Institution in Asia. Ophthalmology 2010;117: by the American Academy of Ophthalmology. ³Hersh P.S., Fry K.L., Bishop D.S. Incidence and Associations of Retreatment After LASIK. Ophthalmology 2003;110: by the American Academy of Ophthalmology 4 Incidence, Outcomes, and Risk Factors for Retreatment After Wave front-optimized Ablations with PRK and LASIK. Randleman J.B., White A.J., Lynn M.J., Hu M.H, Stulting R.D. Journal of Refractive Surgery Volume 25 March 2009

20 If the results of refraction are more stable, which is shown previously, logically this should result in lower retreatment rates over time. Potential ROI of this is below. Update this with site specific numbers. Annual LASIK Procedure Analysis Annual Procedures Average Cost Per Eye Savings Preformed Retreatment Rate % $2,000 $48,000 Annual LASIK Procedure Analysis Annual Procedures Average Cost Per Eye Savings Preformed Retreatment Rate % $2,000 $100,000

21 Published Literature on Lasik Xtra Aslanides IM, Mukherjee AN. Adjuvant corneal crosslinking to prevent hyperopic LASIK regression. Clinical ophthalmology (Auckland, N.Z.). 2013;7: Celik HU, Alagöz N, Yildirim Y, et al. Accelerated corneal crosslinking concurrent with laser in situ keratomileusis. Journal of cataract and refractive surgery. 2012;38(8): Kanellopoulos AJ. Long-term safety and efficacy follow-up of prophylactic higher fluence collagen crosslinking in high myopic laser-assisted in situ keratomileusis. Clinical ophthalmology (Auckland, N.Z.). 2012;6: Kanellopoulos AJ, Kahn J. Topography-guided Hyperopic LASIK With and Without High Irradiance Collagen Cross-linking: Initial Comparative Clinical Findings in a Contralateral Eye Study of 34 Consecutive Patients. Journal of refractive surgery. 2012;28(11):S Nguyen,M. Chuck, R. Corneal collagen cross-linking in the stabilization of PRK, LASIK, thermal keratoplasty, and orthokeratology. Current Opinion, Tamayo GE. Predictable visual outcomes with accelerated corneal cross-linking concurrent with laser in situ keratomileusis. Journal of cataract and refractive surgery. 2012;38(12):2206; author reply Kanellopoulos AJ, Asimellis G. Epithelial Remodeling After Femtosecond Laser-assisted High Myopic LASIK: Comparison of Stand-alone With LASIK Combined With Prophylactic High-fluence Cross-linking. Cornea May;33(5):463-9 Tomita M, Yoshida Y, Yamamoto Y, Mita M, Waring G.,In vivo confocal laser microscopy of morphologic changes after simultaneous LASIK and accelerated collagen crosslinking for myopia: One-year results. J Cataract Refract Surg 2014; 40: Q 2014 ASCRS and ESCRS

22 Thank you!

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