Oyster Point Pharma, Inc.Jeffrey Nau, PhD, MMS
President and CEO
2 ©2018 Oyster Point Pharma, Inc.: Confidential & Proprietary
About Oyster Point Pharma
Oyster Point is leveraging neuroscience to develop innovative therapeutics to address the unifying characteristic of Dry Eye Disease (DED): Loss of Tear Film Homeostasis
First ocular surface sparing pharmaceutical approach for treating DED utilizing a nasal spray to stimulate the
Trigeminal Parasympathetic Pathway
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● The parasympathetic nervous system (PNS) controls tear film homeostasisw34% of basal tear production is due to inhaled air
through the nasal passage1
● Efferent parasympathetic nerves innervate the lacrimal functional unit (LFU) including:wCornea, conjunctiva, accessory lacrimal glands,
meibomian glands, and goblet cells2,3,4
The Trigeminal Parasympathetic Pathway Represents a Novel Approach to Producing Complete Tear Film in Patients with Dry Eye Disease
1Gupta A, Heigle T, Pflugfelder SC. Nasolacrimal stimulation of aqueous tear production. Cornea. 1997 Nov;16(6):645–8. 2van der Werf, F. R. A. N. S., Baljet, B., Prins, M. A. A. R. T. E. N., & Otto, J. A. (1996). Innervation of the lacrimal gland in the cynomolgous monkey: a retrograde tracing study. Journal of anatomy, 188(Pt 3), 591.3LeDoux, M. S., Zhou, Q., Murphy, R. B., Greene, M. L., & Ryan, P. (2001). Parasympathetic innervation of the meibomian glands in rats. Investigative ophthalmology & visual science, 42(11), 2434-2441.4Dartt, D. A., Mccarthy, D. M., Mercer, H. J., Kessler, T. L., Chung, E. H., & Zieske, J. D. (1995). Localization of nerves adjacent to goblet cells in rat conjunctiva. Current eye research, 14(11), 993-1000.
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Trigeminal Nerve Receptor Screening Identified Two Drug CandidatesWhich Have Been Further Developed for Optimal Delivery
OC-01
OC-02
Ideal Molecules Optimized Delivery Device Targeted AdministrationNicoFnic Acetylcholine Receptor
(nAChR) Agonists
• 50 µL• Preservative Free
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nAChR Agonist Activates the Trigeminal Parasympathetic Pathway to Promote Tear Film Production
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Immediate Tear Film Production with Both Candidates
OC-02OC-01
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Mul$center, Randomized, Controlled, Double-masked Clinical Trial to Evaluate the Efficacy of
OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
OC-01 Phase 2b ONSET - Study Design
Diagnosed
Dry Eye Disease
Schirmer’s Score ≤10 mmOSDI ≥23
N=182 Subjects
Placebo
(Vehicle Control)
0.02%
OC-01
Nasal Spray
0.1%
OC-01
Nasal Spray
0.2%
OC-01
Nasal Spray
N=43
● Sign Endpoint: Schirmer’s Score at Week 4
● Symptom
Endpoint: Visual analog eye dryness score (EDS) at Week 3&4
N=47
N=48
N=44
Randomized
1:1:1:1
50 µL
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4.0
6.5
4.4
0.0
3.2
12.911.6
9.8
0.0
10.0
17.2
14.8
12.9
0.0
11.8
20.6
12.6 12.6
0.0
11.4
0
5
10
15
20
25
Day 1 Week 1 Week 2 Week 3 Week 4n=43
OC-01 ONSET - Statistically Significant Improvement in Signs of DED
Mean Change in Schirmer’s Score
Placebo
0.02%
0.1%
0.2%
* Controlled Adverse Environment (CAE)• ITT-observed population
CAE* Chamber
Mea
n Ch
ange
in S
chir
mer
’s S
core
(mm
)
P<0.001 all dosesP<0.001 all doses
P<0.001 all doses
P<0.001 all doses
n=40n=46n=47n=43n=44n=46n=48n=47 n=44 n=40n=46 n=47n=43n=43 n=40
9 ©2018 Oyster Point Pharma, Inc.: Confidential & Proprietary
-6.3
-8.7 -8.5-9.8 -9.9 -9.6
-16.3
-14.4-15.5
-10.6
-13.7 -13.3
-20
-15
-10
-5
05 min 10 min 15 min
N=42N=44 N=44N=45 N=45 N=44N=38 N=38
Eye Dryness Score (EDS) in 5-Minute Increments Post DoseWeek 3 in Controlled Adverse Environment (CAE)
Placebo
0.02%0.1%
0.2%
N=42 N=42 N=45N=38
P=0.006
P<0.001
P<0.05 P<0.05
OC-01 ONSET - Statistically Significant Improvement in Symptoms of DEDM
ean
Chan
ge in
EDS
Sco
re (m
m)
• ITT-observed population
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-7.8
-13.7
-19.5
-8.3
-20
-18
-16
-14
-12
-10
-8
-6
-4
-2
0
OC-01 ONSET - Statistically Significant Improvement in Symptoms of DED
p <0.05
Mean Change from Baseline in Eye Dryness Score (EDS) - Week 4
n= 43 n= 47 n= 46 n= 40
Placebo
0.02%0.1%
0.2%Mea
n Ch
ange
in E
DS S
core
(mm
)
p =0.13
• ITT-observed populaSon
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OC-01 ONSET - Safety and Tolerability Profile
Preferred TermOC-01 (0.02%)
(N=47)OC-01 (0.1%)
(N=48)OC-01 (0.2%)
(N=44)Placebo(N=43)
Sneeze after any instillation 29 (62) 38 (79) 37 (84) 0Cough after any instillation 4 (9) 6 (13) 11 (25) 0Throat irritation after any instillation 0 7 (15) 9 (20) 0Instillation site irritation after any instillation 3 (6) 8 (17) 8 (18) 0
Pharynx dysaesthesia after any instillation 5 (11) 4 (8) 3 (7) 0
Adverse Events Potentially Related to OC-01 AdministrationEvents in >5% of subjects
• All events transient and self-limiting immediately following administration• All events mild in severity
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Multicenter, Randomized, Controlled, Double-masked Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease
OC-02 Phase 2b PEARL - Study Design
Diagnosed Dry Eye Disease
Schirmer’s Score ≤10 mmOSDI ≥23
N=165 Subjects
Placebo (Vehicle Control)
0.2% OC-02
Nasal Spray
1.0% OC-02
Nasal Spray
2.0% OC-02
Nasal Spray
N=42 ● Sign Endpoint: Schirmer’s Score
● Symptom Endpoint: Visual analog eye dryness score (EDS) exacerbated using controlled adverse environment (CAE) chamber
N=41
N=41
N=41
Randomized 1:1:1:1
100 µL
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OC-02 PEARL - Statistically Significant Improvement in Signs of DED
2.6
8.6
17.1
19.3
0
5
10
15
20
25
Placebo 0.20% 1.00% 2.00%
p<0.0001
n=42 n=41 n=41 n=41
p<0.0001
P=0.0018
Mean Change in Schirmer’s Score (N=165)M
ea
n C
ha
ng
e i
n S
ch
irm
er’s
Sco
re (
mm
)
• ITT-observed population
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-6.8
-10.2
-16.5
-19-20-18-16-14-12-10
-8-6-4-20
Placebo 0.20% 1.00% 2.00%
OC-02 PEARL - Statistically Significant Improvement in Symptoms of DED
n=41 n=37 n=41 n=38
Mean Change in Eye Dryness Score (EDS) (N=165)
P=0.0006P=0.0067
P=0.4640
Mea
n Ch
ange
in E
DS S
core
(mm
)
• ITT-observed populaSon
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Multicenter, Randomized, Controlled, Double-masked Clinical Trial to Evaluate the Efficacy of
OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease
OC-02 Phase 2b RAINIER - Study Design
Diagnosed
Dry Eye Disease
Schirmer’s Score ≤10 mmOSDI ≥23
N=53 Subjects
Placebo
(Vehicle Control)
2.0%
OC-02
Nasal Spray
N=19
Sign Endpoint: Schirmer’s Score at Week 4
N=34
Randomized 2:1
50 µL
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4.73.9
2.9
5.9
15.7
9.510.4 10.3
0
5
10
15
20
Day 1 Week 1 Week 2 Week 3 Week 4
OC-O2 RAINIER - Significant Improvement in Signs of DED
Mean Change in Schirmer’s Score
Placebo
OC-02 2.0%
n=34n=19 n=34n=19 n=34n=19 n=34n=18
p=0.08P=0.001P=<0.05
p<0.001
CAE* Chamber
Me
an
Ch
an
ge in
Sch
irm
er’
s Sc
ore
(m
m)
* Controlled Adverse Environment (CAE)• ITT-observed population
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-4.3
-9.6-10
-8
-6
-4
-2
0
OC-O2 RAINIER - Improvement in Symptoms of DED
Eye Dryness Score (EDS) - Week 3 Change from Baseline
Mea
n Ch
ange
in E
DS S
core
(mm
)
• Study not powered to assess symptoms• ITT-observed population
n=18 n=34
Placebo
OC-02 2.0%
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• Study not powered to assess symptoms• ITT-observed populaFon
OC-O2 RAINIER - Improvement in Symptoms of DED in CAE®
-5.4
-7.7
-5.9
-8.7
-11.4 -11.4-12
-10
-8
-6
-4
-2
05 minute 10 minute 15 minute
Eye Dryness Score (EDS) in 5-Minute Increments Post DoseWeek 3 in Controlled Adverse Environment (CAE®)
Mea
n Ch
ange
in E
DS S
core
(mm
)
n=33n=18 n=31n=18 n=30 n=18
Placebo
OC-02 2.0%
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OC-02 RAINIER - Safety and Tolerability Profile
Preferred TermOC-02 (2.0%)
(N=34)Placebo(N=19)
Sneeze after any instillation 22 (65%) 2 (11%)Cough after any instillation 10 (29%) 1 (5%)Throat irritation after any instillation 7 (21%) 0Instillation site irritation after any instillation 4 (12%) 0
Pharynx dysaesthesia after any instillation 3 (9%) 0Administration site dysaesthesia after any instillation 3 (9%) 0
Adverse Events Potentially Related to OC-02 AdministrationEvents in >5% of subjects
• All events transient and self-limiting immediately following administration• All events mild in severity
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Oyster Point is Developing a Disruptive Approach to DED Treatment to Address Significant Unmet Need
● Trigeminal-parasympathe?c pathway- Nico@nic agonists represent a novel mechanism of ac@on to treat DED
● Demonstrated success in mul@ple clinical trials with improvement in pre-specified signs and symptoms of DED in the same clinical trial
● High confidence in clinical/regulatory success
● Unique nasal delivery in an ocular surface sparing nasal spray with no ocular side effects to date
● Phase 3 development to begin in 2019 aMer discussion with regulatory authori@es
A Pharmaceutical Approach to Promote Tear Film Production Addresses the Fundamental Disease Process