# Presentation: 732724

## PMA P030028

- Phakic IOL
- for the correction of Myopia

## Goals of This Panel Meeting

## Assess

- Evaluate
- Identify

## Assess

- Benefits

## Risks

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

## 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

## 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

## Evaluate

- Effectiveness Outcomes
- Safety Outcomes

## Effectiveness Outcomes

- UCVA
- BSCVA
- Predictability
- Stability

## UCVA

-  **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**
**1 yr. ****(n=491)                         ****79%**
**2 yrs. ****(n=355)                     ****83%**
**3 yrs. ****(n=228)                     ****79%**

**20/40 or better**
**   ****99%**
**100%**
**100%**

## Predictability  

-  **±0.50**
**1 yr. ****(n=354)                         ****72%**
**2 yrs. ****(n=262)                     ****74%**
**3 yrs. ****(n=162)                     ****72%**

**± 1.00**
**   ****1yr. ****(465)****            94.5%**
**   ****2yrs. ****(n=333)****          94%**
**   ****3yrs. ****(n=214)****          95%**

## Stability  for the Consistent Cohort

-  **±0.50 between visits 83% to  87% **
**± 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
- Induced Astigmatism
- Cells/Flare
- Corneal Edema
- Increased IOP/Glaucoma
- Cataracts
- ECC loss & Corneal Compromise

## Induced Astigmatism

- 2.4% @ 1 Year
- 2.0% @ 2 Years
- 3.5% @ 3 years

## Inflammatory Responses

- Cells & Flare
- Corneal Edema

## Increased IOP/Glaucoma

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

## Cataracts

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

## ECC loss & Corneal Compromise

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

## Identify

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

## 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 | -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  |

## ECC Changes vary with ACD

| Period | ACD | N | Estimate |
| --- | --- | --- | --- |
| 6M – 3 Yrs. | 3.0mm – 3.2 mm | 7 | -0.0899  |
| 6M – 3 Yrs.
 | >3.2mm to 3.4mm | 22 | -0.0295  |
| 6M – 3 Yrs.
 | >3.4mm to 3.9mm | 51 | -0.0411  |
| 6M – 3 Yrs.
 | >3.9mm | 31 | -0.0637  |

## Two models :

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

## Refractive Benefits 

**The ArtisanTM Lens is indicated for **
**the reduction or elimination of myopia in **
**adults with myopia  > -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**

## Background Question #1

**Notes:**
In a paired analysis, the percent change calculated between baseline and 3 years postop was -4.76% with a standard deviation of 7.8%. When analyzed by interval one can see that losses appear to be higher between the second and third postoperative years at -2.37%  as compared to the interval between years one and two, -1.12%. The sponsor has presented the following endothelial cell loss data:

## Percent Change from Baseline

## 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 |

## 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% |

## 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.
 | >3.2mm to 3.4mm | 22 | -0.0295  |
| 6M – 3 Yrs.
 | >3.4mm to 3.9mm | 51 | -0.0411  |
| 6M – 3 Yrs.
 | >3.9mm | 31 | -0.0637  |

## ∆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 **
** ****above by overall analysis, stratified**
** ****by anterior chamber depth and the**
** ****extrapolations over time provide**
** ****reasonable assurance of safety of the**
** ****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 < –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**
**      ****pupil sizes up to 5.0 mm and up to 6.0**
**      ****mm); and, ** ** **

## 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.**

## Question #4

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