Presbia PLC

Presbia — ESCRS Copenhagen 2016

13 slides from Presbia's conference presentation, September 2016

  1. Slide 1: Presbia Flexivue Microlens Overview and Personal Experience

    Presbia Flexivue Microlens™ Overview and Personal Experience Wayne Crewe-Brown, MD ESCRS Copenhagen, Sept. 2016 Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.

  2. Slide 2: Adding a Bifocal Element (Near Vision)

    Adding a Bifocal Element (Near Vision) Caution: Investigational Device. Limited by Federal (or United States) law to investigational use. 2

  3. Slide 3: Adding a Bifocal Element (Far Vision)

    Adding a Bifocal Element (Far Vision) Caution: Investigational Device. Limited by Federal (or United States) law to investigational use. 3

  4. Slide 4: Procedure

    Procedure  Performed on one eye  Utilizes proven laser technology to create a pocket in the cornea  Customizable to specific patient vision needs  10-minute procedure in doctor’s office; topical anesthesia only Slit lamp image of Presbia Flexivue Microlens™ Presbia Flexivue Microlens™ Caution: I

  5. Slide 5: Surgical Video

    Surgical Video Caution: Investigational Device. Limited by Federal (or United States) law to investigational use. 5

  6. Slide 6: General Data Review

    General Data Review  Review of 2015 surgeries  70 cases from commercial refractive centre  Concurrent LASIK: 45  Emmetropic: 25  Explants  2015 surgery cases: 0 ( 2 pending review)  Total since 2012: 14/281  Glare: 4  Rx stability: 4  Poor Near VA Satisfaction: 4  Poor Dist VA Satisfactio

  7. Slide 7: UCNVA Over 5 line gain from 1M held through 6M

    • UCNVA Over 5 line gain from 1M held through 6M (0.88 – 0.30 logMAR mean)(20/125- 20/40) • UCDVA avg 0.39 (6/12-)logMAR at 3M, but with large and variable range • BCDVA avg 0.17 (6/9+) logMAR at 3M drops 3 lines initially, but by 6M is 1.5 lines. And 12M mean 0.05 logMAR (6/6--), less than 1 line l

  8. Slide 8: Comparative Analysis

    Comparative Analysis Commercial Emmetropes Commercial Concurrent LASIK Clinical Study Emmetropes (data on file at Presbia) Caution: Investigational Device. Limited by Federal (or United States) law to investigational use. 8

  9. Slide 9: UCDVA mean month values

    UCDVA mean 3 month values: • Emmetropic Comm:0.35 • ConLasik Comm: 0.43 • Clinical Study Emmetropic: 0.27 Range of acuity in concurrent lasik much wider across all intervals (look at scale) Caution: Investigational Device. Limited by Federal (or United States) law to investigational use. 9

  10. Slide 10: BCDVA mean 3m values

    BCDVA mean 3m values: • Emmetropic Comm: 0.17 • ConLasik Comm: 0.18 • Clinical Emmetropic: 0.008 Range in concurrent Lasik much wider across all intervals Caution: Investigational Device. Limited by Federal (or United States) law to investigational use. 10

  11. Slide 11: UCNVA mean 3m values

    UCNVA mean 3m values: • Emmetropic Com: 0.32 • ConLasik Com: 0.29 • Clinical Emmetropic: 0.115 Caution: Investigational Device. Limited by Federal (or United States) law to investigational use. 11

  12. Slide 12: Discussion

    Discussion  Commercial outcomes achieved closely related, on average, to those from clinical study setting  Wide range and Standard deviations in commercial setting likely due to “20/happy” practice and inter-clinician variability  Post-operative refraction learning curve with inlay and predictab

  13. Slide 13: Conclusion

    Conclusion  The Presbia Flexivue Microlens™ provides for a safe and effective means of correcting presbyopia  Clinical and commercial outcomes comparable  5-6 line improvement in Near vision  >75% fully independent of reading glasses  Small compromise in distance vision of treated eye not perce

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