PMA P030028 Phakic IOL for the correction of Myopia.

PMA PMA P030028P030028

Phakic IOL Phakic IOL

for the correction of Myopiafor the correction of Myopia

Goals of This Panel Meeting

•Assess

•Evaluate

•Identify

•Risks

•Benefits

Assess

RisksRisks

Operative: Operative: Improper Enclavation – 2Improper Enclavation – 2ndnd surgical proceduressurgical procedures

Other as in cataract surgeryOther as in cataract surgeryCataract Induction/Corneal Cataract Induction/Corneal Damage due to skills of Damage due to skills of surgeonsurgeon

RisksRisks PostoperativePostoperative

Increased IOPIncreased IOP Iritis (Immediate and Persistent)Iritis (Immediate and Persistent) Potential for pigmentary glaucomaPotential for pigmentary glaucoma Critical Loss of Endothelial cells and Critical Loss of Endothelial cells and

corneal functioncorneal function Retinal Detachment Retinal Detachment Dislodgment of IOL Dislodgment of IOL

BenefitsBenefits

Correction of Refractive Error without Correction of Refractive Error without mitigating optical factors as with mitigating optical factors as with spectacle lenses or contact lens spectacle lenses or contact lens complicationscomplications

ReversibilityReversibility Expands the options for correction of Expands the options for correction of

moderate to high myopia for those moderate to high myopia for those not qualifying/interested in corneal not qualifying/interested in corneal refractive proceduresrefractive procedures

Evaluate

Effectiveness Outcomes

Safety Outcomes

Effectiveness Outcomes

UCVAUCVA BSCVABSCVA PredictabilityPredictability StabilityStability

UCVAUCVA

20/20 or better20/20 or better

1 yr. 1 yr. (n=493) (n=493)

35.1%35.1%

2 yrs. 2 yrs. (n=356) (n=356)

34.6%34.6%

3 yrs. 3 yrs. (n=231) (n=231)

31.2%31.2%


86.5%86.5%

87.1%87.1%

84.0%84.0%

BSCVA BSCVA


1 yr. 1 yr. (n=491) (n=491)

79%79%

2 yrs. 2 yrs. (n=355) (n=355)

83%83%

3 yrs. 3 yrs. (n=228) (n=228)

79%79%


99%99%

100%100%

100%100%

Predictability Predictability

±0.50±0.50

1 yr. 1 yr. (n=354) (n=354)

72%72%

2 yrs. 2 yrs. (n=262) (n=262)

74%74%

3 yrs. 3 yrs. (n=162) (n=162)

72%72%

± 1.00± 1.00

1yr. 1yr. (465)(465) 94.5%94.5%

2yrs. 2yrs. (n=333)(n=333) 94%94%

3yrs. 3yrs. (n=214)(n=214) 95%95%

Stability for the Consistent Stability for the Consistent CohortCohort

±0.50 between ±0.50 between visits 83% to visits 83% to 87% 87%

± 1.00 between ± 1.00 between visits 96.2% to visits 96.2% to 98.2%98.2%

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

Safety OutcomesSafety Outcomes

BSCVA – already coveredBSCVA – already covered Induced AstigmatismInduced Astigmatism Cells/FlareCells/Flare Corneal EdemaCorneal Edema Increased IOP/GlaucomaIncreased IOP/Glaucoma CataractsCataracts ECC loss & Corneal CompromiseECC loss & Corneal Compromise

Induced AstigmatismInduced Astigmatism

2.4% @ 1 Year2.4% @ 1 Year 2.0% @ 2 Years2.0% @ 2 Years 3.5% @ 3 years3.5% @ 3 years

Inflammatory ResponsesInflammatory Responses

Cells & FlareCells & Flare Corneal EdemaCorneal Edema

Increased IOP/GlaucomaIncreased IOP/Glaucoma

Secondary to retained viscoelastic & Secondary to retained viscoelastic & steroid responsessteroid responses

Did not persist beyond the first Did not persist beyond the first

monthmonth

Responded to treatment when givenResponded to treatment when given

CataractsCataracts

Total of 49 lens opacities reportedTotal of 49 lens opacities reported

4 were visually significant :4 were visually significant :

3 required extraction3 required extraction 1 lost 2 lines of BSCVA 1 lost 2 lines of BSCVA

ECC loss & Corneal ECC loss & Corneal CompromiseCompromise

Corneal Compromise not reported Corneal Compromise not reported

during studyduring study

ECC loss analysis covered in detail by ECC loss analysis covered in detail by

Dr. Gerry GrayDr. Gerry Gray

•Thresholds of critical inclusion criteria to minimize risks

•Population that may benefit most

Identify

Critical ThresholdsCritical Thresholds

• Thresholds of critical inclusion criteria to minimize risks

• Inclusion criteria specify ≥2000 as the lower limit for preop ECC

Projected Loss Over TimeProjected Loss Over TimeAssuming Linearity/Preop 2500 cells/mm²Assuming Linearity/Preop 2500 cells/mm²

Average Loss Over Average Loss Over Time Time

-49.76 Cells/Year-49.76 Cells/Year

95% CI = (-60.69, -95% CI = (-60.69, -38.83)38.83)

Projected over 10 YearsProjected over 10 Years 2267.432267.43



ECC Changes vary with ACDECC Changes vary with ACD

PeriodPeriod ACDACD NN EstimateEstimate6M – 3 Yrs.6M – 3 Yrs. 3.0mm – 3.2 mm3.0mm – 3.2 mm 77 -0.0899-0.0899

6M – 3 Yrs.6M – 3 Yrs. >3.2mm to 3.4mm>3.2mm to 3.4mm 2222 -0.0295-0.0295


6M – 3 Yrs.6M – 3 Yrs. >3.9mm>3.9mm 3131 -0.0637-0.0637

•Two models :

5mm and 6mm

•Directly relate to pupil sizes in

mesopic conditions and associated

glare & halos

Refractive Benefits Refractive Benefits

The Artisan™ Lens is indicated for The Artisan™ Lens is indicated for the reduction or elimination of myopia in the reduction or elimination of myopia in adults with myopia > -5 to < –20 D with adults with myopia > -5 to < –20 D with less than 2D of astigmatism at theless than 2D of astigmatism at thespectacle plane in patients with stablespectacle plane in patients with stablerefractive errors. refractive errors.

More alternatives for correction in More alternatives for correction in lower ranges of myopia than in lower ranges of myopia than in higher rangeshigher ranges

Background Question #1Background Question #1

Least Squares Means

Visit N Estimate Standard Deviation

Standard Error 95% Confidence Limits

PreOp 183 2754.2380 357.770 26.4471 2702.4020 2806.0730

6 Months 188 2747.5960 373.622 27.2492 2694.1890 2801.0040

1 Year 240 2711.3210 412.006 26.5949 2659.1960 2763.4460

2 Years 285 2680.1730 445.398 26.3831 2628.4630 2731.8830

3 Years 248 2605.2770 429.856 27.2959 2551.7780 2658.7760

Percent Change from Percent Change from BaselineBaseline

Least Squares Means

Visit N Estimate Standard Deviation

Standard Error 95% Confidence Limits

6 Months 139 -0.0036 0.068 0.0058 -0.0149 0.0077

1 Year 134 -0.0106 0.068 0.0059 -0.0223 0.0011

2 Years 135 -0.0255 0.074 0.0064 -0.0379 -0.0130

3 Years 107 -0.0476 0.078 0.0075 -0.0623 -0.0328

Percent Change by PeriodPercent Change by Period

PerioPeriodd

NN EstimatEstimatee

S.D.S.D. Std.Std.

ErrorError95% C.I.95% C.I.

6M-1Y6M-1Y 149149 -0.0117-0.0117 0.0620.062 0.00510.0051 -0.0217 to --0.0217 to -0.00170.0017

1Y-2Y1Y-2Y 198198 -0.0112-0.0112 0.0580.058 0.00410.0041 -0.0192 to --0.0192 to -0.00330.0033

2Y-3Y2Y-3Y 216216 -0.0237-0.0237 0.0630.063 0.00430.0043 -0.0322 to --0.0322 to -0.01530.0153

BL-6MBL-6M 139139 -0.0039-0.0039 0.0720.072 0.00610.0061 -0.0158 to 0.0080-0.0158 to 0.0080

6M-3Y6M-3Y 111111 -0.0475-0.0475 0.0730.073 0.00690.0069 -0.0610 to --0.0610 to -0.03410.0341

ECC Change Over Time from Baseline ECC Change Over Time from Baseline Anterior Chamber Depth 3.0 to 3.2mmAnterior Chamber Depth 3.0 to 3.2mm

6 mos.6 mos. n= 8n= 8 -0.0234-0.0234 -2.34%-2.34%

1 Year1 Year n= 4n= 4 -0.0264-0.0264 -2.64%-2.64%

2 Years2 Years n= 8n= 8 -0.0076-0.0076 -0.76%-0.76%

3 Years3 Years n= 6n= 6 -0.0916-0.0916 -9.16%-9.16%

ECC Changes 6M to 3 Yrs. by ACDECC Changes 6M to 3 Yrs. by ACD

PeriodPeriod ACDACD NN EstimateEstimate6M – 3 Yrs.6M – 3 Yrs. 3.0mm – 3.2 mm3.0mm – 3.2 mm 77 -0.0899-0.0899



6M – 3 Yrs.6M – 3 Yrs. >3.9mm>3.9mm 3131 -0.0637-0.0637

∆∆ECC : Subjects with 3 & 4 Year Follow-ECC : Subjects with 3 & 4 Year Follow-UpUp

Mean ECC at Pre-Op = 2550Mean ECC at Pre-Op = 2550N=27N=27

IntervalInterval % Loss/Gain% Loss/Gain Pre-Op to 3 yearsPre-Op to 3 years 2.12% 2.12%

Pre-Op to 4 yearsPre-Op to 4 years 0.47% 0.47%

3 years to 4 years3 years to 4 years -1.63% -1.63%

Question #1Question #1

Do the endothelial cell data presented Do the endothelial cell data presented

above by overall analysis, stratifiedabove by overall analysis, stratified

by anterior chamber depth and theby anterior chamber depth and the

extrapolations over time provideextrapolations over time provide

reasonable assurance of safety of thereasonable assurance of safety of the

Artisan myopia lens?Artisan myopia lens?


Do the data presented in the PMA Do the data presented in the PMA

provide reasonable assurance of safety?provide reasonable assurance of safety?

Background Question #3Background Question #3

The proposed statement of indications reads: The proposed statement of indications reads:

““The reduction or elimination of myopia in The reduction or elimination of myopia in

adults with myopia > -5 to < –20 D with less adults with myopia > -5 to < –20 D with less

than 2D of astigmatism at the spectacle plane; than 2D of astigmatism at the spectacle plane;

Patients with documented stability of Patients with documented stability of

refraction for the prior 6 months, as demon-refraction for the prior 6 months, as demon-

strated by a spherical equivalent change of strated by a spherical equivalent change of

≤≤0.50D.”0.50D.”

Question 3aQuestion 3a

Does the panel recommend any Does the panel recommend any

modifications to the proposed modifications to the proposed statementstatement

of indications with respect to: of indications with respect to:

a). minimum anterior chamber a). minimum anterior chamber depth (ACD’s of <3.2 mm were depth (ACD’s of <3.2 mm were excluded in the study), excluded in the study),

Question #3bQuestion #3b

b). maximum pupil size (the 2 b). maximum pupil size (the 2 models of models of

Artisan are intended for Artisan are intended for patients withpatients with

pupil sizes up to 5.0 mm and pupil sizes up to 5.0 mm and up to 6.0up to 6.0

mm); and, mm); and,

Question #3cQuestion #3c

cc). minimum preoperative endothelial ). minimum preoperative endothelial cellcell

density? density?

The outcomes of ECC changes reportedThe outcomes of ECC changes reported

in the background data for Question #1 in the background data for Question #1

above should be referenced if the panelabove should be referenced if the panel

wishes to recommend an acceptable wishes to recommend an acceptable minimum minimum

endothelial cell density to qualify a patient.endothelial cell density to qualify a patient.


Do the panel members have any Do the panel members have any

additional labeling recommendations? additional labeling recommendations?

PMA P030028 Phakic IOL for the correction of Myopia.

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