levy imt mda_symposium_oct2013

Implantable Telescope:Implantable Telescope:Is it for me?Is it for me?

October 12, 2013October 12, 2013Macular Degeneration Association Educational SymposiumMacular Degeneration Association Educational Symposium

Marc H. Levy, MDMarc H. Levy, MD

Sarasota Retina InstituteSarasota Retina Institute

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Financial Disclosures

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• IMT-002 Clinical Trial . . . Principal Investigator/Surgeon

• IMT-PAS-01 Clinical Trial . . . Principal Investigator/Surgeon

VisionCare™ / CentraSight™

• VisionCare is the only company to manufacture an implantable miniature telescope.

• CentraSight™ is the treatment program for patients considering, screening, and undergoing surgery for the implantable miniature telescope.

I. Treatment Status Today

II. Technology & Clinical Outcomes

III. Treatment Program

Overview

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FDA Approved: 2009

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Medicare Coverage 2011 – 2012

FLORIDA – FIRST COAST SERVICE OPTIONSLocal Coverage Determination (LCD) for Implantable Miniature Telescope (IMT) (L32822)EFFECTIVE OCTOBER 2012

After consideration of comments received from various experts in the field, and in order to give access to care to beneficiaries who may otherwise not have any other treatment options, limited coverage will be allowed for patients with untreatable end-stage age-related macular degeneration who meet all of the indications…

FLORIDA – FIRST COAST SERVICE OPTIONSLocal Coverage Determination (LCD) for Implantable Miniature Telescope (IMT) (L32822)EFFECTIVE OCTOBER 2012

After consideration of comments received from various experts in the field, and in order to give access to care to beneficiaries who may otherwise not have any other treatment options, limited coverage will be allowed for patients with untreatable end-stage age-related macular degeneration who meet all of the indications…

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American Academy of Ophthalmology

Source: FDA Professional Use Information labeling

• Policies beginning to initiate:

Medicare Advantage Plans

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Most Recent Publication

Functional Daily Living Social

End-Stage AMDProfoundly Reduces

Function/Quality of Life

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Simulations at Distance/Near

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Field of View – External Telescope

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Inside Eye = LARGER Field of View

New Category Device and Procedure

• Medical Device: the telescope is entirely different from an IOL - treats AMD (and not cataract)

• Procedure: Implanting the telescope is entirely different from inserting an IOL

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Scarred MaculaCentral Visual Field Projection (Natural Lens/IOL)

CAT CAT

Telescope ImplantCentral Visual Field Projection

Mechanism of Action

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Implantation Technique

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• No new equipment

• Device is not an IOL

• 12 mm limbal incision & large capsulorrhexis

• Posterior direction and OVDs critical to avoid corneal touch

Postoperative Appearance (6 weeks)

James P. Gilman, CRA

6 Weeks Postoperative

Telescope Eye = Central VisionDistance: Recognizing faces, watching TV, seeing

store signage Near: Reading, playing cards, dining

Retains scanning capability

Other Eye = Peripheral VisionAllows orientation and safe mobility

Telescope Eye = Central VisionDistance: Recognizing faces, watching TV, seeing

store signage Near: Reading, playing cards, dining

Retains scanning capability

Other Eye = Peripheral VisionAllows orientation and safe mobility

Patient Capabilities

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FDA Pivotal Trial: 28-Centers

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• Prospective, 28 US centers• Multi-disciplinary approach

– “Vision training” 6 visits over first 3 months

• 217 visually impaired patients enrolled– Mean Age 76 years – Mean BCVA 20/316 (range: 20/80 – 20/800)

• Follow-Up– 12 months: n=194 of 206 implanted (11

received IOL instead of telescope prosthesis)– 24 months: n=174 of 206 implanted

Phase II/III IMT002 Trial(2002 – 2004)

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One-Year Results Summary

Efficacy• FDA VA endpoint met

– 90% ≥ 2 lines vs. 50% required• 67% improved ≥ 3 lines BCDVA

– vs. 10% of control fellow eyes (p<.0001)• Improved quality of life

– VFQ increase 7-14 points (relevant subscales)

Safety• Preservation of vision: 95%• Endothelial cell density >17% target• Implant well tolerated in eye

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IMT Restores Functional Sight in Blind Patients (5-year follow-up data)

• Pre-IMT vision of 20/320 or worse (statutory blindness)• Significant & sustained improvements in vision (long-term)

FDA Summary of Safety and Effectiveness Data

BCDVA = Best-Corrected Distance Visual Acuity22

Large, Clinically Significant Visual Gain

Intraocular lenses (IOLs) for cataract do not work for End-Stage AMD

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Control

Source: Hudson, HL, et al. Implantable Miniature Telescope for the Treatment of Visual Acuity Loss Resulting from End-Stage Age-Related Macular Degeneration: 1-Year Results. Ophthalmology. November, 2006. 113 (11) 1987-2001.

5-point changes are considered clinically meaningful

VFQ

Sco

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hang

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om B

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IMT Fulfills Unmet Daily Living & Quality of Life Need for Blind Patients

Mean National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Score Change

Benefits across both Functional and Psychosocial Domains

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Basis of CentraSight Program

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Treatment ModelTreatment Model

End-Stage

AMD Patient

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Retina

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Anterior

Segment

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Low

Vision26

Pre-Op Candidacy AssessmentTemplate

•Diagnosis

•Refer

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Retina

• Cornea health

•AC depth, other

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Anterior

SegmentOT/Other

•Functional Goals

•Rehab Potential

Optom

•Low Vision Eval

•Eye Selection

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Low

Vision

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6 or 12 mos FU VisitRetina

Post Op FU

Anterior Segment

Post-Op

Low Vision

Qualified Candidate

Telescope

Implantation

Post-Op Management

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FIRST PATIENT DONE!FIRST PATIENT DONE!February 4, 2013February 4, 2013

81 y.o. white female with81 y.o. white female withAdvanced dry ARMD OUAdvanced dry ARMD OU

Sarasota Memorial HospitalSarasota Memorial HospitalCape Surgery CenterCape Surgery Center

FLORIDA

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POST-OP DAY #1POST-OP DAY #1

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POST-OP DAY #1POST-OP DAY #1

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POST-OP DAY #1POST-OP DAY #1

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POST-OP DAY #1POST-OP DAY #1

6 weeks post-operative

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6 weeks post-operative

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Source: FDA Professional Use Information labeling

• 6 patients implanted since February 2013

• 4 “in the wings”

Patient #1 LV

– Preop Va: 20/300

– Postop Va: 20/70

• “I can now read”

CURRENT STATUS IMTSarasota Memorial Hospital 2013

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CentraSight™ Program

Painting by IMT002 Study Patient