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Overview
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Proprietary FluidVision™ accommodating intraocular lens (A-IOL)
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Only technology that restores “true accommodation”
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No change to the surgical procedure or
post-surgical patient management
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Performance proven in over 100 implants
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Strong IP position
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Multi-billion dollar market potential
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Experienced management team led by Barry Cheskin,
President & CEO and Co-Founder
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Restoration of True Accommodation™
Key Feature
Give Patients the
Ability to See Near,
Far and Anywhere in
Between
Maintain the
Natural Mechanism
of Accommodation
What it Means
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Distance acuity 20/20 or better
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Seamless vision from near to
distance
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Shape change
2.5 diopters of accommodation –
can see well at near (40 cm/16
inches)
Intracapsular vs. sulcus fixated
Ciliary muscle-powered
“Forward” accommodation
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The PowerVision Approach
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Efficiently harness tiny natural
muscular forces in the eye to move
fluids inside the lens
Translate that fluid movement into a
shape change, which leads to a large
change in power
True shape change is many times more
“optically efficient” than designs with a
shifting/vaulting lens
Creates a “continuously variable
monofocal”
Maintains the natural mechanism of
accommodation
Restores True Accommodation™
To see the FluidVision lens in action, visit www.powervisionlens.com
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How the FluidVision Lens Works
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When the eye moves to its
natural accommodated state,
the capsular bag, which now
contains our IOL, squeezes
fluid from the pontoon-like
haptics at the periphery of
our IOL into the center
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This inflates our lens, giving
near vision
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When the eye attempts to
move to its disaccommodated state, the
capsular bag squeezes fluid
the other way
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This deflates our lens, giving
far vision
CAPSULAR BAG
ACCOMMODATED
STATE
(NEAR VISION)
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DISACCOMMODATED
STATE
(FAR VISION)
PowerJect Delivery System
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The FluidVision lens is paired with the novel PowerJect™
“injector”
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The injector utilizes a unique fluid-based method of delivering
the lens into the capsular bag
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No change to the surgical procedure
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Lens comes pre-loaded for ease of use
INJECTOR
PRE-LOADED LENS WITH CARTRIDGE
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Summary of Clinical Studies
Study
Purpose
Sighted Eyes
(monocular)
Single Center
Pilot
Enrollment Completed
2013
Sighted Eyes
(binocular)
Single Center
Pilot
Enrollment Completed
2015
Sighted Eyes
(monocular)
Multi Center
Pts
Key Results/Comments
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Demonstrate device
capability with
monocular
implantation
4.0 mm incision
device
Demonstrate device
capability with
binocular
implantation
4.0 mm incision
device, preloaded injector
Support CE Mark
4.0 mm incision
device, preloaded injector
67
Support CE Mark
and IDE Approval
3.5 mm incision
device, preloaded injector
60
Enrollment Completed
2014
Sighted Eyes
(monocular/
binocular)
Multi Center
Device
26
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8
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Demonstrated injectability
Showed excellent monocular distance (20/20+),
intermediate (20/25) and near (20/32-)
Showed objective accommodation of >1D
Demonstrated stability to 18 months
See detailed slide
Showed that a 1 line gain was available for
near visual acuity, as expected
Showed excellent binocular distance (20/20+),
intermediate (20/20-) and near (20/25-)
See detailed slide
Showed excellent monocular distance (20/20+),
intermediate (20/25) and near (20/32-)
Early results consistent with pilot study
See detailed slide
Study initiated this month, no results to date
Ongoing
= Currently Enrolling
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Binocular Results – Pilot Study
logMAR AVG
-0.10
• Results at 1 month
• Improvement due to
binocular implant:
0.00
 Gain of ~1 line at near
 Gain of ~½ line at
intermediate
0.10
0.20
0.30
mono
binoc
DBCVA
mono
binoc
DCIVA
mono
binoc
DCNVA
Chart From Nichamin, LD, “Update on Fluid Based Accommodating IOL Technology. Presented at AECOS Meeting, March 1 – 4, 2015, Aspen, Colorado
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18 Month Data – Pilot Study
Average Monocular BCDVA
5
0.00
4
Diopters
-0.10
0.10
0.20
0.30
Accommodation by Defocus
3
2
1
0.40
0
1
3
6
12
18
Average Monocular BDCIVA
-0.10
1
0.10
0.10
0.20
0.20
0.30
0.30
0.40
0.40
0.50
1
3
6
12
18
6
12
18
Average Monocular BDCNVA
0.00
0.00
3
1
3
6
12
18
Charts from Nichamin, LD, Roux, P, Potgieter, F, “Twelve to 18 month clinical follow-up on a fluid-filled injectable Accommodating IOL”, Presented at:
ASCRS Symposium and Congress, April 17 – 21, 2015, San Diego, California
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3 Month Data – CE Study
3-Month Monocular VA Data
BCDVA
DCIVA
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DCNVA
Multicenter study
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-0.1
Visual Acuity, logMAR
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3 sites in South Africa
4 sites in Germany
0
0.1
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47 patients at 3 months
0.2
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Monocular data
0.3
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Results similar to pilot
data
0.4
0.5
Chart from Nichamin, LD, Roux, P, Potgieter, F, “Twelve to 18 month clinical follow-up on a fluid-filled injectable Accommodating IOL”, Presented at:
ASCRS Symposium and Congress, April 17 – 21, 2015, San Diego, California
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Product Development Plans
Post implant
adjustment
2.8 mm incision
Near visual
acuity to 20/20
(binocular)
Near
Term
3.5 mm incision
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Longer
Term
Company Plans
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The Company is enrolling its first patients with our 3.5mm
injector system this month
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CE mark expected first half of 2016
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U.S. FDA trials are also expected to begin in 2016
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Company recently completed $30MM of funding in its
Series D round and is raising an additional $10MM as part
of the same round
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