PMA P030028

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PMA P030028

• Phakic IOL
• for the correction of Myopia

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Goals of This Panel Meeting
3

• Assess
• Evaluate
• Identify

4
Assess

• Risks
• Benefits

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Risks

• Operative
• Improper Enclavation 2nd surgical procedures
• Other as in cataract surgery
• Cataract Induction/Corneal Damage due to skills
  of surgeon

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Risks

• Postoperative
• Increased IOP
• Iritis (Immediate and Persistent)
• Potential for pigmentary glaucoma
• Critical Loss of Endothelial cells and corneal
  function
• Retinal Detachment
• Dislodgment of IOL

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Benefits

• Correction of Refractive Error without mitigating
  optical factors as with spectacle lenses or
  contact lens complications
• Reversibility
• Expands the options for correction of moderate to
  high myopia for those not qualifying/interested
  in corneal refractive procedures

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Evaluate

• Effectiveness Outcomes
• Safety Outcomes

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Effectiveness Outcomes

• UCVA
• BSCVA
• Predictability
• Stability

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UCVA

• 20/20 or better
• 1 yr. (n493) 35.1
• 2 yrs. (n356) 34.6
• 3 yrs. (n231) 31.2

• 20/40 or better
• 86.5
• 87.1
• 84.0

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BSCVA

• 20/20 or better
• 1 yr. (n491) 79
• 2 yrs. (n355) 83
• 3 yrs. (n228) 79

• 20/40 or better
• 99
• 100
• 100

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Predictability

• 0.50
• 1 yr. (n354) 72
• 2 yrs. (n262) 74
• 3 yrs. (n162) 72

• 1.00
• 1yr. (465) 94.5
• 2yrs. (n333) 94
• 3yrs. (n214) 95

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Stability for the Consistent Cohort

• Mean Differences in refraction between visits
  ranged from -.02 to -.06 over the 3
  year period

• 0.50 between visits 83 to 87
• 1.00 between visits 96.2 to 98.2

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Safety Outcomes

• BSCVA already covered
• Induced Astigmatism
• Cells/Flare
• Corneal Edema
• Increased IOP/Glaucoma
• Cataracts
• ECC loss Corneal Compromise

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Induced Astigmatism

• 2.4 _at_ 1 Year
• 2.0 _at_ 2 Years
• 3.5 _at_ 3 years

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Inflammatory Responses

• Cells Flare
• Corneal Edema

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Increased IOP/Glaucoma

• Secondary to retained viscoelastic steroid
  responses
• Did not persist beyond the first month
• Responded to treatment when given

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Cataracts

• Total of 49 lens opacities reported
• 4 were visually significant
• 3 required extraction
• 1 lost 2 lines of BSCVA

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ECC loss Corneal Compromise

• Corneal Compromise not reported during study
• ECC loss analysis covered in detail by Dr. Gerry
  Gray

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Identify

• Thresholds of critical inclusion criteria to
  minimize risks
• Population that may benefit most

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Critical Thresholds

• Thresholds of critical inclusion criteria to
  minimize risks
• Inclusion criteria specify 2000 as the lower
  limit for preop ECC

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Projected Loss Over TimeAssuming Linearity/Preop
2500 cells/mm²
Average Loss Over Time -49.76 Cells/Year 95 CI (-60.69, -38.83)
Projected over 10 Years 2267.43
Projected over 20 Years 1769.81
Projected over 30 Years 1272.18
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ECC Changes vary with ACD
Period ACD N Estimate
6M 3 Yrs. 3.0mm 3.2 mm 7 -0.0899
6M 3 Yrs. gt3.2mm to 3.4mm 22 -0.0295
6M 3 Yrs. gt3.4mm to 3.9mm 51 -0.0411
6M 3 Yrs. gt3.9mm 31 -0.0637
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• Two models
• 5mm and 6mm
• Directly relate to pupil sizes in mesopic
  conditions and associated glare halos

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Refractive Benefits

• The Artisan Lens is indicated for
• the reduction or elimination of myopia in
• adults with myopia gt -5 to lt 20 D with
• less than 2D of astigmatism at the
• spectacle plane in patients with stable
• refractive errors.
• More alternatives for correction in lower ranges
  of myopia than in higher ranges

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Background Question 1
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Percent Change from Baseline
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Percent Change by Period
Period N Estimate S.D. Std. Error 95 C.I.
6M-1Y 149 -0.0117 0.062 0.0051 -0.0217 to -0.0017
1Y-2Y 198 -0.0112 0.058 0.0041 -0.0192 to -0.0033
2Y-3Y 216 -0.0237 0.063 0.0043 -0.0322 to -0.0153
BL-6M 139 -0.0039 0.072 0.0061 -0.0158 to 0.0080
6M-3Y 111 -0.0475 0.073 0.0069 -0.0610 to -0.0341
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ECC Change Over Time from Baseline Anterior
Chamber Depth 3.0 to 3.2mm
6 mos. n 8 -0.0234 -2.34
1 Year n 4 -0.0264 -2.64
2 Years n 8 -0.0076 -0.76
3 Years n 6 -0.0916 -9.16
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ECC Changes 6M to 3 Yrs. by ACD
Period ACD N Estimate
6M 3 Yrs. 3.0mm 3.2 mm 7 -0.0899
6M 3 Yrs. gt3.2mm to 3.4mm 22 -0.0295
6M 3 Yrs. gt3.4mm to 3.9mm 51 -0.0411
6M 3 Yrs. gt3.9mm 31 -0.0637
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?ECC Subjects with 3 4 Year Follow-UpMean
ECC at Pre-Op 2550N27
Interval Loss/Gain
Pre-Op to 3 years 2.12
Pre-Op to 4 years 0.47
3 years to 4 years -1.63
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Question 1

• Do the endothelial cell data presented
• above by overall analysis, stratified
• by anterior chamber depth and the
• extrapolations over time provide
• reasonable assurance of safety of the
• Artisan myopia lens?

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Question 2

• Do the data presented in the PMA
• provide reasonable assurance of safety?

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Background Question 3

• The proposed statement of indications reads
• The reduction or elimination of myopia in
• adults with myopia gt -5 to lt 20 D with less
• than 2D of astigmatism at the spectacle plane
• Patients with documented stability of
• refraction for the prior 6 months, as demon-
• strated by a spherical equivalent change of
• 0.50D.

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Question 3a

• Does the panel recommend any
• modifications to the proposed statement
• of indications with respect to
• a). minimum anterior chamber depth (ACDs of
  lt3.2 mm were excluded in the study),

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Question 3b

• b). maximum pupil size (the 2 models of
• Artisan are intended for patients with
• pupil sizes up to 5.0 mm and up to 6.0
• mm) and,

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Question 3c

• c). minimum preoperative endothelial cell
• density?
• The outcomes of ECC changes reported
• in the background data for Question 1
• above should be referenced if the panel
• wishes to recommend an acceptable minimum
• endothelial cell density to qualify a patient.

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Question 4

• Do the panel members have any
• additional labeling recommendations?