ophthalmology innovation showcase – powervision
TRANSCRIPT
2PowerVision │ FluidVision™ IOL
The FluidVision™ A-IOL Advantage
First true shape changing, fluid-driven IOL
Mimics eye’s natural accommodative process
Creates a continuously variable monofocal
Designed to restore True AccommodationTM
Excellent visual outcomes out to 36 months
3PowerVision │ FluidVision™ IOL
How the FluidVision Lens Works
• When the eye moves to its natural accommodated state, the capsular bag squeezes a tiny amount of fluid (less than a drop) from the haptics at the periphery of the A-IOL into the center
• This inflates the lens, giving near vision
• When the eye attempts to move to its disaccommodated state, the capsular bag squeezes fluid the other way
• This deflates the lens, giving far vision
4PowerVision │ FluidVision™ IOL
Evolution of an Accommodating IOL
Conceptual • Non Optical• Non-foldable• Proof of
concept in blind eyes
• Single Center Study
• Non-foldable• Single Center
Study
• Foldable• Never
released to clinic
• Superseded by Gen 4
FluidVision™• Foldable• PowerJect™
injector (pre-loaded)
• Started with 4.0 mm, moved to 3.5 mm incision
• Single Center and Multicenter Studies
FluidVision 20/20™• Foldable• Nearly twice the
accommodation• Achieve 20/20 across
all distances• Minor mechanical
and optical design changes
• Studies to get underway soon
Gen 0 Gen 1 Gen 2 Gen 3 Gen 4 Gen 5
5PowerVision │ FluidVision™ IOL
Summary of Recent Clinical Studies
Sighted Eyes (monocular)
Single Center PilotEnrollment completed
2013
4.0 mm incision device
26 eyes
Sighted Eyes (monocular)Multi Center
Enrollment completed 2014
4.0 mm incision device,
pre-loaded injector
67 eyes
Sighted Eyes (monocular)Multi Center
Enrollment completed 2015
3.5 mm incision device,
pre-loaded injector
50 eyes
Sighted Eyes (binocular)
Single Center PilotEnrollment completed
2015
4.0 mm incision device
pre-loaded injector
8 eyes
6PowerVision │ FluidVision™ IOL
Excellent, Stable Outcomes from Pilot Study
M1(n=26)
M3(n=26)
M6(n=26)
M12(n=24)
M18(n=19)
M24(n=18)
M36(n=11)
-0.20
-0.10
0.00
0.10
0.20
0.30
0.40
Best Corrected Distance VA
AVG
logM
AR V
A
M1(n=26)
M3(n=26)
M6(n=25)
M12(n=23)
M18(n=17)
M24(n=17)
M36(n=8)
0.00
1.00
2.00
3.00
4.00
AVG Accommodation by Defocus
Diop
ters
• Patients achieved 20/20 or better mean BCDVA
• Patients showed stable intermediate and near visual acuities over 36 months:
- Mean DCIVA of +0.11 logMar
- Mean DCNVA of +0.26 logMar
• The FluidVision AIOL achieves stable results in the capsular bag over time
• All results monocular
7PowerVision │ FluidVision™ IOL
Multi-Center Outcomes Comparable to Pilot
M3 (n=121)
M6 (n=114)
M12 (n=61)
M18 (n=45)
M24
-0.20
-0.10
0.00
0.10
0.20
0.30
0.40
Best Corrected Distance VA
AVG
logM
AR V
A
M3 (n=121)
M6 (n=114)
M12 (n=61)
M18 (n=45)
0.00
1.00
2.00
3.00
4.00AVG Accommodation by Defocus
AVG
logM
AR V
A
• Multi-Center Studies show comparable outcomes to Single Center Pilot Study, including stable intermediate and near visual acuities out to 18 Months
• Decreased incision size to 3.5 mm with improved injector and procedure
• All results monocular
8PowerVision │ FluidVision™ IOL
Proven Subjective Accommodation
Mean Accommodation by Defocus at 1-Month and 12-Month visit
1-month 12-month0.00
1.00
2.00
3.00
4.00
5.00
Binocular Patients (n=8) Monocular Patients (n=26)
Dio
pter
s
Defocus Curve: 12-Month Data
-3-2.5-2-1.5-1-0.500.511.52
-0.3
-0.2
-0.1
5.55111512312578E-17
0.1
0.2
0.3
0.4
0.5
0.6
0.7
Defocus (D)
logM
AR
66 cm 40 cm
Bilaterally implanted subject with mean VA of 20/40 or better through 5.0 D of defocus
• Stable accommodative function over time• Average binocular improvement of >1.0 D
over monocular results
9PowerVision │ FluidVision™ IOL
Proven Objective Accommodation
Average objective accommodation = 1.7D** Average objective accommodation based on 6 month results, Multi-Center (monocular), status March 2016
10PowerVision │ FluidVision™ IOL
Product Development Plans
FluidVision 20/20
3.5 mmIncision
Near visualacuity to 20/20
3.2 mm incision Toric
Post implantadjustment,
2.8 mm incision