Refractec ViewPoint™ CK Systemfor the

Treatment of Spherical Hyperopia

Sheryl Berman, MD

Medical Officer

FDA/CDRH/ODE/DOED

Questions for Panel Consideration1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?

2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?

3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?

4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?

5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?

6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?

Question for Panel Consideration

1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?

Induced Increase in Cylinder Magnitude

(% of eyes)

Month 1 Month 3 Month 6 Month 9 Month 121D 34% 26% 24.3% 14.4% 12.3%>1D 21% 15% 14.2% 7.4% 6.4%

>1.5D 9% 5% 4% 2.1% 1.5%2D 6% 3% 2% 1% 1%>2D 3% 2% 1% <1% <1%

Induced Change in Vector Cylinder Magnitude

(% of eyes)

Month 6 Month 9 Month 121D n/a n/a n/a>1D 25% 18% 16%>1.5D 10% 5% 5%2D n/a n/a n/a>2D 3% 2% 1%

Induced Absolute Axis Shift(% of all treated eyes)

Month 6 Month 9 Month 12>15 degrees 68% 63% 58%>30 degrees 49% 46% 44%>45 degrees 38% 38% 37%>60 degrees 27% 25% 26%>75 degrees 15% 14% 11%Mean shift(degrees)

37.84 36.58 35.46

Post-op Cylinder Magnitude(% of eyes)

Note: all eyes had baseline cylinder magnitude 0.75D or less

Month 6 Month 9 Month 121D 40% 29% 32%

1.5D 14% 7% 7%2D 5% 2% 3%

Effect of Induced Cylinder on Uncorrected Visual Acuity

(% of eyes at month 12)

Eyes with<1D induced

cylinder

Eyes with1D induced

cylinderUCVA 20/20 51% 24%UCVA 20/25 74% 48%UCVA 20/40 92% 76%Mean UCVA 20/27 20/33

Question for Panel Consideration

2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?

Question for Panel Consideration

3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?

Stability of MRSE12-month consistent cohort

(n=186)

Month 3 - 6 Month 6 - 9 Month 9 - 12Change MRSE 1D 94% 98% 97%Mean change (MD)paired difference

0.31D 0.08D 0.12D

Extrapolatedannual change

1.24D 0.32D 0.48D

95% CI 0.23, 0.39 0.02, 0.14 0.06, 0.18

Stability of MRSEcohort with 2 consecutive visits

Month 3 – 6N=381

Month 6 – 9N=370

Month 9 – 12N=195

Change MRSE 1D 93% 98% 97%Mean change (MD)paired difference

0.26D 0.09D 0.13D

Extrapolatedannual change

1.04D 0.36D 0.52D

95% CI 0.20, 0.32 0.05, 0.13 0.07, 0.19

Accuracy of MRSE

Month 1 Month 3 Month 6 Month 9 Month 12

Undercorrection>1D 3% 3% 6% 8% 6%>2D <1% 1% <1% 1% 1%

Overcorrection>1D 23% 13% 6% 5% 2%>2D 6% 2% 1% 1% 0%

Question for Panel Consideration

4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?

Visual Symptoms with 5% increase over baseline

(% eyes with moderate to severe symptoms)

Pre-op Month 6 Month 9 Month 12Dryness (marked) 1% 6% 5% 2%Halos (moderate) 2% 8% 9% 9%Diplopia (marked) 1% 6% 5% 3%Fluctuation inVision (moderate)

3% 8% 7% 8%Fluctuation inVision (marked)

1% 7% 5% 3%Glare (moderate) 6% 11% 8% 11%Variation in visionin normal light(moderate)

4% 9% 8% 6%

Variation in visionin dim light(moderate)

8% 13% 12% 11%

Question for Panel Consideration

5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?

Requested Indication for Use

• CK treatment for the reduction of spherical hyperopia in the range of:• +0.75 to +3.25 D of cycloplegic spherical hyperopia• -0.75 D or less of refractive astigmatism• +0.75 to +3.00 D cycloplegic spherical equivalent

• In patients with 0.50 D difference between preoperative manifest and cycloplegic refractions

• In patients 40 years of age or older • The magnitude of correction diminishes over time with an

average loss of approximately 10% of the intended correction at one year

Question for Panel Consideration

6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?

Questions for Panel Consideration1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?

2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?

3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?

4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?

5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?

6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?

Question for Panel Consideration

1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?

Question for Panel Consideration

2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?

Question for Panel Consideration

3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?

Question for Panel Consideration

4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?

Question for Panel Consideration

5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?

Question for Panel Consideration

6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?