Anterior Segment Company Showcase - LacriScience at OIS@AAO 2016. Presenter: Chris Geddes, PhD, Chief Biomedical/Plasmonics Consultant Powered by: Healthegy For more ophthalmology innovation Visit us at www.ois.net

1. The LacriPen™ – A Handheld
Portable Ophthalmic Osmometer
and Diagnostic Instrument
…a portable laboratory in the palm of your hand
Presented by:
Dr Chris D. Geddes, Ph.D., FRSC
Professor, University of Maryland (UMBC)
for
LacriScience LLC, Paul T. Gavaris MD
Managing Member

2. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Osmolarity… Dry Eye… LacriPen™
• Normal homeostasis and clarity of the
cornea requires regulated tear flow, the
primary driver of which is osmolarity.
Therefore, osmolarity is the single
biophysical measurement that captures the
balance of inputs and outputs within the
tear film dynamics. As such it can reliably
diagnose dry eye initially and follow the
therapeutic response to treatment
secondarily. The LacriPen™
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3. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Tear Osmolarity and Dry Eye
Tomlinson, et. al.2 - 2006
Metadata analysis of peer
reviewed measurements for tear
samples from normal eyes and
subtypes of dry eyes.
Established an osmolarity
threshold of 316 mOsm for dry eye
diagnosis.
0.
1.
260. 280. 300. 320. 340. 360. 380. 400.
Osmolarity
All Studies 1978-2005
Osmolarity
Probability
Dry Eyes
Mean = 326.9 mOsm
S.D. = 22.1 mOsm
Normal Eyes
Mean = 302.2 mOsm
S.D. = 9.7 mOsm
315.6 mOsm
2) Tomlinson A, Khanal S, Ramaesh K, Diaper C, and McFadyen A. “Tear Film Osmolarity: Determination of a Referent for Dry Eye
Diagnosis”, Investigative Ophthalmology & Visual Science, October 2006, Vol. 47, No. 10
Farris1 - 1994
Suggested that tear osmolarity
measurement offers a possible
gold standard for the diagnosis of
dry eye disease.
1) Farris RL. “Tear osmolarity: a new gold standard?” AEMB. 1994;506: 495–503.
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4. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Point of Care
Osmolarity Gold Standard for Dry Eye Stages
Normal 293 to 304 mOsm/L
Mildly dry 305 to 316 mOsm/L
Moderately dry 317 to 328 mOsm/L
Severely dry 329 to 340 mOsm/L
Within a range of only 12 mOsm/L defining the stages, any
instrument with a standard deviation above +/- 6 mOsm/L, has
no validity for diagnosis and utility in dry eye patient
management.
LacriPen™
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5. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Surface Plasmon Resonance:
How it Works
Typical SPR Image
The location of the central minima of
the SPR curve is proportional to the
refractive index of the tear fluid in
contact with the gold sensing surface.
Light Source
Image Sensor
Tear
Fluid
SPR
Prism
Gold Film
Sensing
Surface
SPR “Line”
The Surface Plasmon Resonance Technique
for Tear Osmolarity Measurement
and more !
RelativeResponse
SPR Angle (pixels)
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6. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Surface Plasmon Resonance
“Truly rocket science!”
LacriPen™
From bench top…………… to the eye
Rapid Measurements < 1 sec
Disposable – one time use
Sensor
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7. © Copyright 2016, LacriScience, LLC Slide
LacriScience
LacriPen™ response to Contrived Tears
80
81
82
83
84
85
86
87
88
89
90
280 290 300 310 320 330 340 350
PixelNumber
Tear Osmolarity, mOsms/L
855 nm Channel
Linear (855 nm Channel)
Linear Response over Dry Eye Range
Instant read-out on Contact with tears
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8. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Rapidly Responds – Large Dynamic Sensing
Range
50
55
60
65
70
75
80
85
90
95
100
250 270 290 310 330 350 370
PixelNumber
Osmolarity, mOsms/L
855 nm Channel
855 nm Channel
• Rapid Measurement < 1 Sec
• Large Pixel Sensing Range 260 – 360 mOsms/L
• Sensitivity +/- 2 mOsms/L
• Highly Sensitive on both Optical Channels
• LacriPen Self-Calibrates
Data recorded on our 3rd Generation prototype
Large Sensing Range
30
40
50
60
70
80
250 300 350
PixelNumber Osmolarity, mOsms/L
950 nm Channel
950 nm…
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9. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Patient Response with LacriPen™
Measurement time < 1 sec
Simply touch the tears
the Pen does the rest !
0
500
1000
1500
2000
2500
3000
3500
4000
4500
0 50 100 150
Rel.Intensity
Pixel Number
Patient 1
water eye
Dry eye
0
500
1000
1500
2000
2500
3000
3500
4000
4500
0 50 100 150RelIntensity
Pixel Number
Patient 2
water eye
Mildly Dry eye
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10. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Point of Care
Adjunctive Dry Eye Diagnostics
MMP-9
1. Identify MMP-9 as low as 5 ng/mL
2. Quantify MMP-9 to monitor treatment
3. No Anesthesia Simply touch tear film
for instant readout
4. No scraping of eyelid
LacriPen™
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11. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Robust use of Antibodies on Smart Sensors
Antibody, Ab
(anti-MMP-9)
Antigen (MMP-9)
CM-Dextran Coated
Gold slides
Top of sensor prism, gold film
Anti-Fouling coating
Plastic Cap
Gold Film
CM-Dextran Coating
Antibody for analyte, MMP-9, MRSA etc
Surface Blocking, reduce non-specific absorption
Layering of smart sensors
NHS-ester coupling
The Dextran coating is used to routinely anchor surface
antibodies or DNA using
well-known amine Chemistries.
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12. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Diagnostics
A veritable laboratory for real-time patient management
MRSA
1. Immediate Diagnosis
2. No waiting for cultures
3. No need for MRIs
4. No need for expensive broad-spectrum antibiotics
5. Huge savings in patient care
LacriPen™
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13. © Copyright 2016, LacriScience, LLC Slide
LacriScience
LacriPen™ Diagnostics
A veritable laboratory for real time diagnosis and
medical management using – Smart Sensors
Adenovirus No anesthesia, no scrapping of lid
especially in children
Bacteria Gram-neg
Biomarkers May detect early cancer
Enzymes
Chemicals
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14. © Copyright 2016, LacriScience, LLC Slide
LacriScience
Q & A
Changing the Way we Think
about and Use Ophthalmic Diagnostics Today
The Lacripen™
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