Visual Performance of Eyes in the Grail StudySumit Garg, MD

International Society of PresbyopiaSeptember 13, 2019

CONFIDENTIAL

LensGen Milestones

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• 2012 - Company founded by Ramgopal Rao and Dr. Roger Steinert • 2013 - Awarded COSAT grant from Johnson & Johnson• 2014 - Raised $3.4M in early seed rounds • 2015 - Implanted first Juvene IOLs in pilot studies• 2017 - Closed $28M Series A Financing • 2019 - Initiated Grail Study in January • 2019 - Dr. Eric Donnenfeld presented Grail Study results at ASCRS • 2020 - Planning to initiate FDA Study in early 2020

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Accommodation with Age

3

10 year old

70 year old

45 year old

8

7

6

5

4

3

2

1

0

Acc

omm

odat

ion

(dio

pter

s)

Based on data from: Anderson HA, Hentz G, Glasser A, Stuebing KK, Manny RE. Minus-lens-stimulated accommodative amplitude decreases sigmoidally with age: a study of objectively measured accommodative amplitudes from age 3. Invest Ophthalmol Vis Sci. 2008 Jul;49(7):2919-26. and Turner PL, Mainster MA. Circadian photoreception: ageing and the eye's important role in systemic health. Br J Ophthalmol. 2008 Nov;92(11):1439-44.

Realities of Declining Vision

• 40’s – lens begins to stiffen and lose focus power

• 50’s – loss of accommodation and decreased night vision

• 65 plus – no accommodation, possible cataract and poor visual quality

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Market Opportunity

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Surgeons• High patient satisfaction

(patients want to see at every distance)

• Low number of complaints (halos, glare & night vision)

• Simple, straight forward surgical procedure

• No additional chair time• Enhanced safety

Industry• Growth in Premium market• Larger Presbyopia market• Unique long-lived IP• Long term market viability• Platform technology

Premium Patients• Full range of vision

without contrast loss• Spectacle free vision• High quality vision –

No glare, No halos• Standard cataract –

No compromises• Enhanced safety Juvene

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LensGen Technology

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Juvene Emulates the Natural Crystalline Lens

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Clinical

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PRESBYOPIA Grail Study

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• Fifty-four (54) of 59 eyes implanted

• Eleven (11) of 14 bilateral subjects 1-6 months post-op

• Eight (8) of 10 control eyes implanted

• Forty-four (44) eyes 1-6 months post-op

• Eleven (11) at 6 months follow-up

• Twenty three eyes (23) at 3 months follow-up

• Eighteen eyes (18) at 1 month follow-up

• Two eyes (2) no data at this time

• Zero (0) lens related adverse events

• 100% of bilateral subjects are spectacle independent

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PRESBYOPIA

0.48

0.25

0.00

0.050.09

0.15

0.20

0.27

0.38

0.55

-0.20

-0.10

0.00

0.10

0.20

0.30

0.40

0.50

0.60

0.70

0.80

0.90

1.00-4.5-4-3.5-3-2.5-2-1.5-1-0.500.511.522.5

Vis

ual A

cuity

Diopters

Monocular Defocus Curve - Most Recent follow Up Data

Grail N=44 EDoF (Symfony*) N=62 Technis Monofocal* N=65

20/20

20/25

20/32

20/40

20/16

*FDA Summary of Safety and Effectiveness Data (SSED)

Grail Monocular Defocus Curves

9

66cm 40cm

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PRESBYOPIA

0.34

0.14

-0.03-0.01

0.010.05

0.090.13

0.26

0.41

-0.20

-0.10

0.00

0.10

0.20

0.30

0.40

0.50

0.60

0.70

0.80

0.90

1.00-4.5-4-3.5-3-2.5-2-1.5-1-0.500.511.522.5

Vis

ual A

cu

ity

Diopters

Binocular Defocus Curve - Most Recent follow Up Data

Grail Binocular N=11 EDoF (Symfony SSED) Binocular N=62

20/20

20/25

20/32

20/40

20/16

66cm 40cm

Grail Binocular Defocus Curves

10

20/20+

20/25-

20/20-

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Bilateral Patient Satisfaction

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QoV Questionnaire N=11 Eyes

Glare None

Halos None

Starbursts None

Hazy Vision None

Blurred Vision None

Distortion None

Double Vision None

Image Fluctuation None

Focusing Difficulty None

Judging Depth Perception None

ENHANCEDSAFETY

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Closer to Emmetropia

Average -0.61 DStd. Dev. 0.48 D

Target vs. Achieved Post-op Refractive Error N=41

3.4

3.6

3.8

4

4.2

4.4

4.6

1 3 6 9 12A

nter

ior C

ham

ber D

epth

(mm

)Post-Operative Visit (months)

JRG NRE RGA YMS GRD

Paired samples t-test comparing lens position at month 12 to month 1 is

not significant (p = 0.704).

ELP Stability in Pilot Study N=5

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

-2.00 -1.50 -1.00 -0.50 0.00 0.50 1.00 1.50 2.00

Ach

ieve

d D

iop

tric

Ou

tco

me

Expected Dioptric Outcome

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ENHANCEDSAFETY

6 MONTHS 22 MONTHS 33 MONTHS

Pilot Data – clinical experience 54 months

No PCO – Pristine Capsules

54 MONTHS

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Standard IOL Compromises

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Compromises

• ELP Shift and Tilt

• Rotation

• PCO

• Vitreo-retinal Tension

Unacceptable for Premium IOL Patients

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EMMETROPIA

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Biomimetic Capsule Filling

PATIENT BENEFITS

• Stable ELP

• Stable Refraction

• Minimal Rotation

• Negligible PCO

• Less Vitreo-retinal Tension

Satisfied Premium IOL Patients

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PRESBYOPIA Grail Study Summary – Bilateral Patients

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No Glare, No Halos, No Glasses: • Full range of vision without splitting light from distance to near

• 100% of patients are spectacle independent • 100% of patients are 20/25 at distance and intermediate • 91% of patients are 20/32 at near

• Excellent QOV – no glare, halo or other dysphotopsia reported

Earlier Pilot Study Results:• Stable ELP and no loss of accommodative effect • No PCO in any eyes out to 54 months

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Drug Delivery

Juvene Toric

The LensGen Platform

Juvene

Monofocal ToricLensGen Base Lens Biometric

Sensors

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Current Development

Potential Future Develop Opportunities

PLUS

Monofocal

Thank You