Anterior Segment Company Showcase - Sensimed AG at OIS@AAO 2016. Presenter: David Bailey, CEO Powered by: Healthegy For more ophthalmology innovation Visit us at www.ois.net

1. The SENSIMED Triggerfish®
Focusing on the Clinical Benefit in Glaucoma
24 hour profile of ocular dimensional changes

2. Contact lens-based solution – SENSIMED Triggerfish®
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The first ever FDA approved Contact Lens Sensor system, March 2016
Automated recording of Ocular Volume Changes (OVC) over 24 hours
 Proven safe system
 Repeatable 24 hour profiles
 Individual signature-like profiles
 Highly sensitive
 Patient- & practitioner-independent
 Promising clinical benefits
SENSIMED Triggerfish®

3. SENSIMED Triggerfish®
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Multiple Peer-reviewed articles to support these claims
“The continuous IOP [-related]
monitoring does not appear to
be affected by differences in
corneal thickness that occur
during overnight [TF] wear.”
Acta Ophthalmologica 2012
“Repeated use of the contact lens sensor
demonstrated good safety and tolerability. The
recorded IOP patterns showed fair to good
reproducibility, suggesting that data from
continuous 24-hour IOP monitoring may be useful
in the management of patients with glaucoma.”
Archives of Ophthalmology 2012
“This new pressure-sensitive contact lens is tolerable and safe over a 24-hour
wearing period in healthy subjects and glaucoma patients.”
Journal of Glaucoma 2013

4. SENSIMED Triggerfish®
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Multiple Peer-reviewed articles to support these claims
“The IOP-related pattern cosinor amplitude was reduced in
NTG patients with a successful SLT treatment whereas the
non-success group exhibited an increase of cosine amplitude.
Higher diurnal and 24-hour CLS pattern variability was observed
in non-success patients 1 month post-SLT.”
Medicine 2014
“The 24-hour [TF] data showed a
simulated peak timing close to the 24-
hour IOP peak timing obtained using the
pneumatonometer.”
Plos One 2015
“Intraocular pressure-related parameters obtained with 24-
hour recording with a [TF] were associated with the rate of
visual field progression in treated glaucomatous eyes. This
technology may be useful in detecting eyes at higher risk of
glaucoma progression while receiving treatment.”
Ophthalmology 2016

5. SENSIMED Triggerfish®
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A new measurement principle - OVC
IOP exerts force on the eye shell, leading to ocular volume changes.
Sensing through the ocular shell is influenced by ocular biomechanics.
pressure
strain gauge
contact lens
tissue biomechanics

6. SENSIMED Triggerfish®
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Glaucoma sleep lab – without hospitalisation.

7. SENSIMED Triggerfish®
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Creating a new category of approval
CE-mark
ISO & CAN/CSA ISO 13485:2003
De Novo granted
indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24
hours to identify the window of time to measure intraocular pressure by conventional clinical methods.
Japan registration on-going; new category of device required
Overall Objective: Expand labelling to strengthen utility claims and gain
reimbursement. Where is the focus?

8. Ocular volume change – clinical relevance
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A meaningful supplement to IOP
OVC as a new biomarker to PREDICT the course of the disease vs.
just monitoring the progression
OVC as a CLASSIFIER for Glaucoma patients having normal
pressure (NTG)
OVC as a new and additional endpoint to assess the
EFFECTIVENESS OF INTERVENTION

9. Quote from IOP monitoring session at ESCRS in
Copenhagen - “we want to monitor the progression”
TF has the potential to predict progression
Tan et al., IOVS 2015 (25 PACG)
Larger fluctuations, in terms of gradients and curvatures, at certain
time periods of the day may be associated with disease
progression in PACG.
Flatau et al., Jama Ophthalmo 2016 (22 glaucoma patients and 11
healthy subjects)
 Glaucoma eyes with past progressive VF loss showed greater TF
increase in face down position, suggesting a relationship between
TF and glaucoma progression
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10. Quote from IOP monitoring session at ESCRS in
Copenhagen - “we want to monitor the progression”
TF has the potential to predict progression
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De Moraes et al., 2016

11. Quote from IOP monitoring session at ESCRS in
Copenhagen - “we want to monitor the progression”
TF has the potential to predict progression
Comments from Dr D. Garway-Heath (Moorfields, UK) in IGR
“…confirmation of the generalizability of the results is required…the
[TF] model needs to be validated in an independent dataset…”
Additional analyses based on a 445 patient registry
 Above results strengthened in a more generalized population
(registry in 13 countries), with a training and a testing set.
 Planned prospective study over a 2 year period in the US / EU to
confirm finding and deliver labelling claims and reimbursement
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12. Ocular volume change – NTG classification
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Many patients have normal pressure yet still loose vision.
Mean prevalence of POAG in population over 40y
1.41% in Asia
4% in Central Japan
92% of which are NTG
A must have tool in Japan

13. NTG classification – TF has the potential to classify NTG
Clear and undisturbed picture of what happens at night
Average 24h SENSIMED Triggerfish® Profiles (10 per group)
Vertical lines indicate differences in
peak times
Horizontal lines indicate the mesor
(average cycle value)
Agnifili et al, Acta Ophthalmol. 2015: 93: e14–e21
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14. NTG classification – TF has the potential to classify NTG
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In-house data
TF was found to be a reasonably good classifier using in-house
registry data
 Resulted in significant interest in Japan to perform validation study
Below 0.5 an AUC is considered as random
POAG
vs
Healthy
275 POAG
222 Healthy
Significant differences
in TF profiles
Cross validated model,
AUC = 0.703
NTG
vs
Healthy
Significant differences
in TF profiles
Cross validated model,
AUC = 0.71
91 NTG
222 Healthy

15. Ocular volume change – NTG classification
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Big positive commitment from Japan
 SEED investment: Closed convertible loan of 10MCHF of which
half came from SEED with a dedicated portion of that investment
to conduct the clinical study in Japan
 Leadership from the President of the Japanese Glaucoma Society
in the development of the study protocol and interaction with
PMDA
 12 Japanese sites have confirmed interest in participating in the
study
 Confirmation of protocol and sites November 2016 –
implementation Q1 2017 following PMDA approval

16. Next steps
Clinical validation studies
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Japan
Study
Primary objectives: TF as a predictor of glaucoma progression rate
Accurate diagnosis of NTG
2017 2018 2019
Study
start
Study end
and analyses
2y follow up period
Expected nb of participants: 200 NTG and healthy (12 centers)
End of
recruitment
US
Study
Primary objective: TF as a predictor of glaucoma progression rate
2017 2018 2019
Expected nb of participants: 200 OAG (5 centers)
Study
start
Study end
and analyses
2y follow up period
End of
recruitment

17. Conclusion
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Moving SENSIMED Triggerfish® to acceptance
 An evolving unmet need exists in glaucoma diagnosis and management; augment
IOP measurement.
 SENSIMED Triggerfish® is accumulating experience which indicates that it could
make a significant contribution with its new biomarker – Ocular Volume Change –
the subject of multiple and significant peer review articles; NTG classification, Fast
Vs Slow prediction.
 Japanese Glaucoma Society support for key pivotal study to build a classification
model for NTG patients. SEED support and investment.
 Possibility to transition from monitoring progression to predicting progression –
Fast Vs Slow.
 Advanced plans to implement progression study in US and EU to build and validate
a predictive tool. Seeking a strategic partner to collaborate
 Sensimed have built a strong core competence in CL sensing and is the first
company to make CL sensing a reality for patients – plans to expand sensing
applications.

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