PMA P Phakic IOL for the correction of Myopia

Goals of This Panel Meeting

Assess Evaluate Identify

Risks Benefits Assess

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

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

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

Evaluate Effectiveness Outcomes Safety Outcomes

Effectiveness Outcomes UCVA UCVA BSCVA BSCVA Predictability Predictability Stability Stability

UCVA 20/20 or better 20/20 or better 1 yr. (n=493) 35.1% 2 yrs. (n=356) 34.6% 3 yrs. (n=231) 31.2% 20/40 or better 86.5% 87.1% 84.0%

BSCVA 20/20 or better 20/20 or better 1 yr. (n=491) 79% 2 yrs. (n=355) 83% 3 yrs. (n=228) 79% 20/40 or better 99% 100%

Predictability ±0.50 ± yr. (n=354) 72% 2 yrs. (n=262) 74% 3 yrs. (n=162) 72% ± yr. (465) 94.5% 2yrs. (n=333) 94% 3yrs. (n=214) 95%

Stability for the Consistent Cohort ±0.50 between visits 83% to 87% ±0.50 between visits 83% to 87% ± 1.00 between visits 96.2% to 98.2% ± 1.00 between visits 96.2% to 98.2% Mean Differences in refraction between visits ranged from -.02 to -.06 over the 3 year period

Safety Outcomes BSCVA – already covered BSCVA – already covered Induced Astigmatism Induced Astigmatism Cells/Flare Cells/Flare Corneal Edema Corneal Edema Increased IOP/Glaucoma Increased IOP/Glaucoma Cataracts Cataracts ECC loss & Corneal Compromise ECC loss & Corneal Compromise

Induced Astigmatism 1 Year 1 Year 2 Years 2 Years 3 years 3 years

Inflammatory Responses Cells & Flare Cells & Flare Corneal Edema Corneal Edema

Increased IOP/Glaucoma Secondary to retained viscoelastic & steroid responses Secondary to retained viscoelastic & steroid responses Did not persist beyond the first month Did not persist beyond the first month Responded to treatment when given Responded to treatment when given

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

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

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

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

Projected Loss Over Time Assuming Linearity/Preop 2500 cells/mm² Average Loss Over Time Cells/Year 95% CI = (-60.69, ) Projected over 10 Years Projected over 20 Years Projected over 30 Years

ECC Changes vary with ACD PeriodACDNEstimate 6M – 3 Yrs. 3.0mm – 3.2 mm M – 3 Yrs. >3.2mm to 3.4mm M – 3 Yrs. >3.4mm to 3.9mm M – 3 Yrs. >3.9mm

Two models : 5mm and 6mm Directly relate to pupil sizes in mesopic conditions and associated glare & halos

Refractive Benefits The Artisan™ Lens is indicated for the reduction or elimination of myopia in adults with myopia > -5 to -5 to < –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 More alternatives for correction in lower ranges of myopia than in higher ranges

Background Question #1

Percent Change from Baseline

Percent Change by Period PeriodNEstimateS.D.Std.Error 95% C.I. 6M-1Y to Y-2Y to Y-3Y to BL-6M to M-3Y to

ECC Change Over Time from Baseline Anterior Chamber Depth 3.0 to 3.2mm 6 mos. n= % 1 Year n= % 2 Years n= % 3 Years n= %

ECC Changes 6M to 3 Yrs. by ACD PeriodACDNEstimate 6M – 3 Yrs. 3.0mm – 3.2 mm M – 3 Yrs. >3.2mm to 3.4mm M – 3 Yrs. >3.4mm to 3.9mm M – 3 Yrs. >3.9mm

∆ECC : Subjects with 3 & 4 Year Follow-Up Mean ECC at Pre-Op = 2550 N=27 Interval % Loss/Gain Pre-Op to 3 years 2.12% Pre-Op to 4 years 0.47% 3 years to 4 years -1.63%

Question #1 Do the endothelial cell data presented Do the endothelial cell data presented above by overall analysis, stratified above by overall analysis, stratified by anterior chamber depth and the by anterior chamber depth and the extrapolations over time provide extrapolations over time provide reasonable assurance of safety of the reasonable assurance of safety of the Artisan myopia lens? Artisan myopia lens?

Question #2 Do the data presented in the PMA provide reasonable assurance of safety?

Background Question #3 The proposed statement of indications reads: “The reduction or elimination of myopia in adults with myopia > -5 to -5 to < –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.”

Question 3a Does the panel recommend any modifications to the proposed statement of indications with respect to: a). minimum anterior chamber depth (ACD’s of <3.2 mm were excluded in the study),

Question #3b b). maximum pupil size (the 2 models of Artisan are intended for patients with Artisan are intended for patients with pupil sizes up to 5.0 mm and up to 6.0 pupil sizes up to 5.0 mm and up to 6.0 mm); and, mm); and,

Question #3c c). minimum preoperative endothelial cell density? 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.

Question #4 Do the panel members have any additional labeling recommendations?