Oyster Point Pharma, Inc. · 8 ©2018 Oyster Point Pharma, Inc.: Confidential & Proprietary 4.0...

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