The SENSIMED Triggerfish®

Focusing on the Clinical Benefit in Glaucoma

24 hour profile of ocular dimensional changes

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Contact lens-based solution – SENSIMED Triggerfish®

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®

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SENSIMED Triggerfish®

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

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SENSIMED Triggerfish®

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

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SENSIMED Triggerfish®

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

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SENSIMED Triggerfish®

Glaucoma sleep lab – without hospitalisation.

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SENSIMED Triggerfish®

Creating a new category of approval

CE-mark

ISO & CAN/CSA ISO 13485:2003

De Novo grantedindicated 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?

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Ocular volume change – clinical relevance 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

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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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Quote from IOP monitoring session at ESCRS in Copenhagen - “we want to monitor the progression”

TF has the potential to predict progression

De Moraes et al., 2016

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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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Ocular volume change – NTG classification

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

NTG classification – TF has the potential to classify NTGClear 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 2

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NTG classification – TF has the potential to classify NTGIn-house dataTF 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

POAGvs

Healthy

275 POAG222 Healthy

Significant differences in TF profiles

Cross validated model, AUC = 0.703

NTGvs

Healthy

Significant differences in TF profiles

Cross validated model, AUC = 0.71

91 NTG222 Healthy

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Ocular volume change – NTG classificationBig 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

Next stepsClinical 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

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ConclusionMoving 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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