A phase I-II clinical trial tested the topical ophthalmic solution EV06 for treating presbyopia. The trial found that EV06 was well-tolerated and improved near visual acuity over 90 days compared to placebo. A higher proportion of EV06 subjects gained at least 10 letters of near visual acuity. Additional studies are warranted to determine the duration of treatment effect beyond 90 days.

1. A Topical Treatment to
Correct Presbyopia
Results from A Phase I-II Study of
EV06 Ophthalmic Solution
for the Treatment of Presbyopia
Bill Burns
Chief Executive Officer

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Higher proportion of EV06 subjects had gain of 10
letters or more (DCNVA) compared to placebo
Note: Preliminary analysis based on LOCF in study eye only
0
5
10
15
20
25
30
35
40
45
50
Day 8 Day 15 Day 31 Day 61 Day 91
%ofSubjects
Percent of Subjects with Gain of ≥10 Letters in DCNVA
Placebo
EV06
P=0.04
P-value is based on
Fisher’s exact test
P=0.003
DCNVA=Distance-corrected near visual acuity

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Presbyopia is the MOST prevalent eye condition
In the US, almost 90 MILLION will have presbyopia by 2020…
…which will rise to over 120 MILLION by 20501
1.3B
2011 20502005
1B
1.8B
2020
1.4B
Globally, nearly 2 BILLION people will have presbyopia by 2050
1. Holden BA, Fricke TR, Ho SM, et al. Global Vision Impairment Due to Uncorrected Presbyopia. Arch Ophthalmol. 2008;126(12):1731-1739. doi:10.1001/archopht.126.12.1731.

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Aging EyeYoung Eye
How Is Accommodation Lost?
Why Does Presbyopia Happen?
Cytosol Displacement
Centrally = Accommodation
Lens Stiffening =
Compromised
Accommodation
Oxidation induced disulfide bonds
form between crystalline proteins -
a Leading Potential Cause
↓
↑

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What is EV06?
How Does it Work?
• EV06 (Lipoic Acid Choline
Ester, 1.5%) is a prodrug
Choline Lipoic Acid
Lipoic Acid Choline Ester
• EV06 penetrates cornea
- metabolized into
Choline & Lipoic Acid,
two naturally occurring
substances
Dihydrolipoic Acid
• Enzymes within
lens fiber cells
chemically reduce
Lipoic Acid to
active form
Dihydrolipoic Acid

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How Does EV06 Work?
Dihydrolipoic Acid
Chemically Reduces
Disulfide Bonds
Dihydrolipoic Acid
Disulfide Bonds
LENS ELASTICITY IS REGAINED
Cytosol Displacement
Centrally = Accommodation
↓
↑

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Study Design
• Prospective, randomized, double-masked, placebo-controlled multicenter Phase I/II study
• 75 subjects with hyperopia, myopia, or emmetropia and a diagnosis of presbyopia
randomized 2:1 to receive EV06 BID or placebo BID
Objective: Evaluate safety and efficacy of EV06 in improving DCNVA in
subjects with presbyopia
DCNVA=Distance-corrected near visual acuity
-7 Days  Day 0 Day 1 Day 1  Day 7 Day 7  Day 90
SCREENING
Key inclusion criteria:
• 45-55 years of age
• Binocular DCNVA worse than
20/40
• BCDVA of 20/20 or better in
each eye
• A difference of ≤ 0.50 D
between manifest refraction
spherical equivalent and
cycloplegic refraction spherical
equivalent
Randomization
(2:1,EV06:Placebo)
Unilateral Dosing Bilateral Dosing
EV06 1.5% BID
N=50
EV06 1.5% BID
N=50
PLACEBO BID
N=25
PLACEBO BID
N=25

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Study Details
Demographics
Category Value
Age; Mean (range) 50.5 yrs (45-55)
Gender Female 71%
Race Caucasian 70.7%
Patient Type Emmetropes 68%
Myopes 20%
Hyperopes 12%
• Four Study Sites across US
• Visual Assessments included:
• Manifest Refraction
• Best Corrected Distance Visual Acuity (BCDVA)
• M&S Vision testing system – all sites
• Distance Corrected Near Visual Acuity (DCNVA)
• Defocus Curve Testing
• iTrace Aberrometer Wavefront Measures – one site only

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EV06 Safety & Tolerance Results
• No Subjects Discontinued For Adverse Events,
Safety Concerns, or Tolerability
• No Sight Related Adverse Events
• Upon Instillation
– Mean EV06 Comfort Rating 3.0
– Mean Placebo Comfort Rating 2.7
• (Scale 0 – 10; “0” = Very Comfortable)
• No Change In Best Corrected Distance Visual
Acuity

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EV06 Efficacy Results
• Achieved both Primary Efficacy Results:
– Improvement in Distance Corrected Near Vision
Acuity (DCNVA) in the Study Eye after
treatment, which continued throughout the
dosing period
– Higher proportion of subjects with gain of ≥10
letters in DCNVA in the study eye vs. placebo

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0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
0.45
0.5
0 20 40 60 80 100
LogMARScore
Treatment Day
DCNVA LogMAR - OU
Placebo
EV06
P=0.017
P=0.022
P=0.027 P=0.005
P-values for two sample t-test, EV06 vs. Placebo
Improvement in Distance Corrected Near Vision Acuity
DCNVA=Distance-corrected near visual acuity

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Gain of ≥ 10 Letters - DCNVA
Note: Preliminary analysis based on LOCF in study eye only
0
5
10
15
20
25
30
35
40
45
50
Day 8 Day 15 Day 31 Day 61 Day 91
%ofSubjects
Percent of Subjects with Gain of ≥10 Letters in DCNVA
Placebo
EV06
P=0.04
P-value is based on
Fisher’s exact test
P=0.003
DCNVA=Distance-corrected near visual acuity

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EV06 DCNVA Snellen score - Day 1 & Day 91
0 0
8
22
36
22
12
0
12
24 24
22
8 8
0 0
20/20 20/25 20/32 20/40 20/50 20/63 20/80 20/100
%Subjects
Day 1 EV06 Day 91 EV06
Poly. (Day 1 EV06) Poly. (Day 91 EV06)
Improved shift in
Snellen Scores

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Placebo DCNVA Snellen score - Day 1 & Day 91
0 0
8
20
40
16
12
14
12
8
24
32
8
4 0
20/20 20/25 20/32 20/40 20/50 20/63 20/80 20/100
%Subjects
Day 1 Placebo Day 91 Placebo
Poly. (Day 1 Placebo ) Poly. (Day 91 Placebo)
No material shift in
Snellen Scores

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Conclusions and Next Steps
• EV06 restores near vision in presbyopic patients
• EV06 demonstrated an acceptable safety and
tolerability profile
• Additional study is warranted
• Follow-on study of subjects from just completed
trial to determine duration of treatment effect at:
−120 days post-dosing
−270 days post-dosing

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THANK YOU
Clinical Sites
Sall Research Medical Center, Inc.
Artesia, California
North Valley Eye Medical Group
Mission Hills, California
Comprehensive Eye Care, Ltd.
Washington, Missouri
Total Eye Care
Memphis, Tennessee

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THANK YOU
Advisors
Jerry Cagle, PhD
Dan Durrie, MD
Dennis Dean, PhD
Adrian Glasser, PhD
David Gooden, PhD
Marjorie Lou, PhD
Stella Robertson, PhD
Encore Vision Team
Kathryn Crawford, PhD
Shikha Barman, PhD
Judy Gordon, DVM
Jerry Stein, PhD
William Garner, PhD
Margaret Garner, PhD
Dennis Dean, PhD
Lexitas Pharma Services, Inc
Regulatory Professionals, Inc (RPI)
Board of Directors
Peter Bennett
William Burns
Adrienne Graves, PhD
John Hunkeler, MD
Les Kreis
Richard Lindstrom, MD
Ed Tyler (Chairman)