Ocularis Presentation 0908[2]

April 11, 2023 ConfidentialConfidential

© 2008 Ocularis Pharma - Confidential March, 2008

Ocularis Pharma: Overview

• Developing Nyxol® Eye Drops to Treat Night Vision Complaints– Night Myopia– Post-IOL surgery– Post-LASIK surgery

• Retasking an approved drug for a new indication– Lower risk, lower cost, faster to market– $400+ million market potential (US)– Large ophthalmic companies now entering market

• Experienced management team and field-leading advisors


Management Group• Al Meyer, CEO

– Former EVP & CFO, PathoGenesis

• Charlie Hoffmann, Principal, Business Development– Investment banker Prudential Vector Healthcare, First Boston,

Goldman Sachs

• Jerry Horn, MD, Principal, Scientific & Medical– Ophthalmic surgeon specializing in LASIK– Inventor of Nyxol Eye Drops

• Bill Pitlick, PhD, Principal, Product Development – Chief Scientific Officer, Avera Pharma– Former VP, Clinical/Regulatory Affairs, PathoGenesis

• Keith Terry, Principal, Market Development– Director, Strategic Marketing, Immunology, Abbott Labs– Former Managing Director, International, PathoGenesis


Advisory Board

• Glen Bradley, Retired CEO, CIBA Vision

• Bill Gantz, Executive Chairman, Ovation Pharma– Founder & CEO, PathoGenesis– Former President & COO, Baxter

• Stephen Klyce, PhD, Professor, LSU– Expert on corneal aberrations and pupil size

• Marguerite McDonald, MD, OCLI– LASIK pioneer

• Peter Drake, PhD, Founder & EVP, Vector Securities_______________________________________________

• Art Ginsburg, PhD, Chairman, Vision Sciences Corp– Expert on contrast sensitivity


Night Vision Complaints (“NVCs”)

• NVCs include several conditions– Glare– Halos– Starbursts– Poor depth perception

• Significant unmet need, increasingly recognized– 20+% of patients complain to eye docs about NVCs– 6-7% have moderate/severe condition, i.e. night vision worse

than 20/45

• No medications indicated to treat NVCs today


Nyxol Eye Drops to Treat Night Vision Complaints

Typical Night Vision Disturbance Clear Night Vision


Cause of Night Vision Complaints

• Imperfections exist in periphery of cornea – “higher order aberrations”

• In dim light, pupil dilates more than needed

• Light enters through periphery and scatters

• Treatment thesis:

Limit pupil dilation to improve night vision


● Mechanism of Action– Alpha 1 antagonist– Inhibits iris dilator muscle– Limits pupil dilation

Nyxol Eye Drops: Manage Pupil Dilation

TypicalDilation

ManagedDilation


Nyxol Eye Drops: Manage Pupil Dilation Before After


• Phentolamine mesylate– Long used as intravenous hypotensive– Recently approved (5/08) as injection to reverse oral anesthesia– Reformulated as an eye drop to improve night vision

• Nyxol activity– Use as needed– One drop in each eye– Works in < 30 minutes, lasts 8 hours

• Nyxol safety– Topical use, no systemic effect observed– Very well tolerated in the eye, very comfortable– Some users experience redness, manage w/ OTC redness

reducer

Nyxol Eye Drops: Drug Profile


• Established Intellectual Property – Four U.S. patents issued for use to improve dim light vision

– Five patents pending

• Established Market Dimension– External market research – 3 Health Advances studies

– Internal market research – 4 Patient, M.D. and O.D. studies

– Conclusion: Nyxol is a $400+ million market in US

• Established Regulatory Pathway with FDA– Acknowledged serious unmet medical need

– Stated no systemic tox required

– Discussed pivotal study design

– Agreed on primary endpoint (contrast sensitivity)

Nyxol Eye Drops: Milestones Achieved


• Proved Treatment Thesis - NOVA Study– 100 patients with NVCs in 5 patient groups

• Night myopia• Post-LASIK• High myopia• Contact lens• Cataract

– Employed consensual pupillary light reflex to make pupils smaller

– Measured night vision (LCVA) before and after– Study shows conclusively

Making pupils smaller improves night vision



• Completed 4 Phase 1/2 clinical trials– Investigator INDs– 101 subjects in total– Single dose, 4 concentrations, placebo controlled

• Demonstrated that Nyxol is a viable drug– Clinically & statistically significant improvement in night vision

• Contrast Sensitivity

• Low Contrast Visual Acuity

• Wavefront Aberrometry

• Subjective Questionnaire

– Well tolerated in the eye – very comfortable– No systemic effects



• In 12 months - Conduct multiple dose (14 day) Phase 2 study– Company IND– 40 subjects with severe night vision complaints– Full panel of objective and subjective evaluations

• In 18 months - Initiate Phase 3 clinical trial– Broad indication – moderate/severe NVCs– 2 pivotal studies– 500 patients in each– 6 month treatment– Follow 100 patients for full year

Nyxol Eye Drops: Development Plan Overview


Nyxsol Recent Milestone

• Received Term Sheet From Major Pharmaceutical Company For $28M


• Developed comprehensive formulation strategy: existing patents precede FDA approved use & formulation same drug for different medical application

• Plan:

• 1 Corporate IND (animal tox, formulation/stability) $500k

• 2 Definitive Phase II study: 60 pts, 14 days $500k

• 3 Manufacturing: Ready fill, blowfill seal, pf free $500k

• 4 Comprehensive NOVA, other marketing study $500k

• 5 Management, overhead, other $500k

• Result: $400 M market drug w Corp IND; Phase I, II completed. Valuation expected: $50M - $100M.

Nyxol Eye Drops: 2009 - 2010


Comparable Phase 3 Programs

Product Nyxol® Restasis® Alphagan P®

IndicationModerate to Severe NVC

Moderate to Severe Dry Eye

Open Angle Glaucoma

# of Patients 1,000 1,200 926

Duration 6 months 6 months 1 year


Ocularis Strategy: Next Steps• Attain value-creating milestones

– Conduct investigator IND studies• 7 day use study/focus group• Population study in normals/incidence & severity of NVCs• 28 day use study/focus group

– Obtain formulation license

– Obtain company IND• Conduct formulation/28 day stability study• Conduct 28 day topical animal tox study

– Complete multi-dose Phase 2 study

– Initiate pivotal Phase 3 study

• Partner, license or sell to major ophthalmic companyAlcon AMOAllergan Bausch & Lomb


Ocularis: Investment Summary

• Experienced, successful management group • Strong intellectual property protection

• Strong clinical evidence that Nyxol works

• Large unmet market

• No competitive drug product

• Clear execution planLow cost / Low risk / Fast to market

• Clear Exit Strategy


Ocularis PharmaAppendices

1. Recent Night Vision Market Developments

2. Night Vision Complaint Market

3. Results of Recent Phase II Trial

4. NOVA Study Results

5. Optometrist Survey Results

6. Recent Phentolamine Approval

7. Clinical Study: HOA Analysis


Ocularis Pharma

Appendix 1

Recent Night Vision Market Developments


Accidents at Night

• National Highway Traffic Safety Administration & National Safety Council say

– 90% of driver’s reaction depends on vision

– Fatality rate at night 3 times daytime rate

– Pedestrians 3 to 7 times more vulnerable at night than daytime

– 25% of travel occurs during darkness

– 49% of fatal crashes occur at night


Bausch & Lomb IntroducesNew Contact Lens

• B&L introduced PureVision® Contact Lenses in January, 2008

– Improves vision in low-light conditions

– 74,000 patient on-line study confirmed night vision and night driving were improved with PureVision CLs

– Aspheric design of PureVision CLs reduces spherical aberration and improves night vision


“Shedding Light on Driving in the Dark”

• Study conducted by Kelton Research September, 2007

• Sponsored by– ACUVUE® Contact Lenses (Johnson & Johnson)– Road & Travel Magazine (women’s automotive and travel issues)

• Published by Johnson & Johnson Vision Care late 2007

• Sample– 515 nationally representative Americans– 18 years old and older– Vision corrected

• Rx Eyeglasses 83%• Rx Contact Lenses 25%• Reading Glasses 14%• LASIK 4%

– “Driving in the dark” - driving in low-light conditions• Early AM• Night


Driving in the Dark

• Percent of 150 million vision corrected Americans who– Have difficulty driving in the dark 32%

all or most of time

– Experience glare 48%

– See halos or starburst patterns 28%

– Have difficulty seeing signs or exits 26%

– Have difficulty judging distances 22%


How They Feel Behind the Wheel in the Dark

Men Women

• Uncomfortable 17% 27%– Not confident in the dark

• Unsafe 17% 25%– Could not see signs

• Anxious 16% 25%– Do not want to drive


Younger vs Older Drivers in the Dark

18-49 50+

• Difficulty driving in the dark 36% 22%

• Hard time seeing signs & exits 30% 17%


Market Summary• B&L product introduction proves there is a night vision

market

• J&J study proves the market is larger than our estimates– 1/3 have difficulty driving in the dark– More women than men experience night vision problems– More younger people than older people have night vision

problems

• J&J is poised to launch their new contact lens for night vision shortly

• Other companies are launching night vision products (contact lenses and spectacle lenses)– Wavetouch– Ophthonics– Essilor


Ocularis Pharma

Appendix 2

Night Vision Complaint Market


Night Vision Complaint Market:Summary Conclusions

• Total potential NVC market exceeds $420 million

• Nyxol can achieve sales of over $150 million

• Nyxol will be used to improve vision performance

• Optometrists will be the primary prescribers of Nyxol

• Nyxol will be marketed by a major ophthalmic company salesforce to 35,000 ODs and 18,000 MDs


Night Vision Complaint Market:Market Research and Analysis

• Ocularis has commissioned or conducted seven market research studies– Optometrists– Ophthalmologists– Patients

• Key conclusions– 20+% of patients visiting eye doctors complain about night vision– Moderate/Severe NVCs comprise about one third of these

patients (~6.5%)– Optometrists would prescribe an eye drop indicated for NVCs– Patients would buy and use eye drops at the forecast price point


NVC Patients Seen by ODs

• Avg patient visits per mo 250

• Night vision complaints 20%

• Treatable 65%

• Treatable NVC patients per month 32.5

• Months per year 12

• Treatable NVC patients per year 390

• ODs in US 35,000

• Annual Treatable NVC patients in US 13.7 mm

• Moderate to Severe NVC patients in US 4.5 mm


Nyxol Eye Drops: Target Prescribers• Primary – Optometrists (ODs), whose focus is

visual function of the eye:– Myopia– Astigmatism– Hyperopia– Presbyopia

• Secondary – Ophthalmologists (MDs), whose focus is diseases of the eye: – Glaucoma– Macular degeneration– Cataracts

• Rationale– ODs are more attuned to night vision complaints than MDs– ODs will embrace a new prescription opportunity


Night Vision Complaint Market

Moderate/Severe NVC Market Segments

Night Myopia (Non-Surgical) $327 mm

Post-Surgical $95 mmIOLs & LASIK

Total $422 mm


Night Vision Complaint Market:Night Myopia Market Potential

NightMyopia(000's)

Population 118,931

Incidence of Mod/Sev NVCs 6.6%Patients w/ Mod/Sev NVCs 7,849

Patients Treatable 65%

Patients Seeking Therapy 40%

Target Mod/Sev NVC Patients 2,041

Annual Rx Price (4 Rxs/Yr @ $40) $160

Mod/Sev NVC Market Potential $326,536

Penetration 40%

Nyxol Sales Projection $130,615


Night Vision Complaint Market:Summary Market Potential

NightMyopia IOL LASIK Total

Population 118,931 11,529 10,200 140,659

Incidence of Mod/Sev NVCs 6.6% 7.5% 6.4% 6.7%Patients w/ Mod/Sev NVCs 7,849 866 655 9,370

Patients Treatable 65% 65% 65%

Patients Seeking Therapy 40% 60% 60%

Target NVC Patients 2,041 338 255 2,634 % of Population 1.7% 2.9% 2.5% 1.9%

Rx Frequency/Rx Price 4/$40 4/$40 4/$40

Mod/Sev NVC Market Potential $326,536 $54,013 $40,872 $421,422

Penetration 40% 40% 40% 40%

Nyxol Sales Projection $130,615 $21,605 $16,349 $168,569

Nyxol Market Potential 2015 (000's)

Post Surgical

NightMyopia IOL LASIK Total

Population 118,931 11,529 10,200 140,659

Incidence of Mod/Sev NVCs 6.6% 7.5% 6.4% 6.7%Patients w/ Mod/Sev NVCs 7,849 866 655 9,370

Patients Treatable 65% 65% 65%

Patients Seeking Therapy 40% 60% 60%

Target NVC Patients 2,041 338 255 2,634 % of Population 1.7% 2.9% 2.5% 1.9%

Rx Frequency/Rx Price 4/$40 4/$40 4/$40

Mod/Sev NVC Market Potential $326,536 $54,013 $40,872 $421,422

Penetration 40% 40% 40% 40%

Nyxol Sales Projection $130,615 $21,605 $16,349 $168,569

Nyxol Market Potential 2015 (000's)

Post Surgical


• Study parameters– 380 patients with no serious eye pathology– Photopic (normal light) corrected vision was 20/25 or better– “Night myopia” – defined as 20/45 or worse

• Findings– 16.6% incidence of “night myopia”– “Moderate to severe” NVCs about 6.6%

• Ocularis correlates “night myopia” with pupil diameter

Fejer Study - 1992: Incidence of “Night Myopia”

Incidence Est Avgof Night Scotopic

Age Myopia Pupil (mm)

16-25 32.7% 7.0

26-45 15.7% 6.0

46-65 5.5% 5.0

>65 3.1% 4.5

Total 16.6% ~6.0

Incidence Est Avgof Night Scotopic

Age Myopia Pupil (mm)

16-25 32.7% 7.0

26-45 15.7% 6.0

46-65 5.5% 5.0

>65 3.1% 4.5

Total 16.6% ~6.0


Night Vision ComplaintsResults of Initial Optometrist Survey

• Incidence of NVCs

– Patients complain about night vision• Unprompted 20%• Prompted >20%



• Nyxol™ Eye Drops to Treat NVCs– 70% of patients with NVCs would benefit– ODs would readily adopt a product that was safe and

effective– ODs would prescribe empirically to patients– ODs would be primary prescribers– Patients would be willing to pay $30/month or

$360/year for such a product



• Optometrists today are not prescribing drugs to treat NVCs– Alphagan P is rarely prescribed because

• Side effects• Declining efficacy• Confusion with pharmacist over using a glaucoma med for

night vision complaints– Do not prescribe pilocarpine for NVCs because of serious side

effects– Prescribe glasses, rewetting drops or tell patient to look away

from glare source, all with limited results


Why Would ODs Treat NVCs?

• New, value added therapy for patients

– ODs get a new therapeutic tool to improve night vision– ODs get a continuing, regular revenue stream vs periodic

eyeglass/contact lens update every year or two– Example - dry eye therapy is taking off with Restasis

• ODs writing Rxs

• Simple diagnosis and treatment

• No capital investment required


• No drugs approved for treating NVCs

• Several existing drugs have pupil constricting side effects– Alphagan P– Pilocarpine

• For treating NVCs, these drugs have– Limited effectiveness– Unacceptable side effects

Nyxol Eye Drops: Competition


Ocularis Pharma

Appendix 3

Nyxol – Results of Recent Phase II Trial


• Single dose, Phase II study– 24 subjects (16 on drug, 8 on placebo)– Severe night vision complaints– Positive effect on LCVA with consensual pupillary light reflex

• Measurement– Primary endpoint - Contrast Sensitivity– High & low contrast visual acuity– Wavefront aberrometry– Subjective questionnaire– Pupil size

• Study goals– Demonstrate Nyxol Eye Drops work and are safe– Compare measurement techniques

Nyxol Eye Drops: OP-NYX-SNVLatest Study Completed – 10/08


• Co-Principal Investigators– Dr. Marguerite McDonald– Dr. Eric Donnenfeld

• Study Site - Ophthalmic Consultants of Long Island– 25 eye docs, 7 offices– Largest ophthalmic practice in New York– Full time clinical research staff

• Study status– 47 subjects screened, 24 enrolled– First subject enrolled 8/14/07– Last subject completed 10/30/07– Data analysis continuing– Study report available early 2008

Nyxol Eye Drops: OP-NYX-SNV


Study Demographics - 24 Total Subjects– Gender

• 7 Male• 17 Female

– Age• 14 45 & Under• 10 Over 45

– Type• 19 Night Myopes• 5 Post-surgical

– 3 LASIK

– 1 RK

– 1 IOL

Preliminary Analysis OP-NYX-SNV


• Female, 38 years old, night myopia (no surgery)

• Night vision problems– Glare– Halos– Depth perception

• Limits night driving

Nyxol Eye Drops: OP-NYX-SNVSubject 002 Demographics


OP-NYX-SNV: Subject 002Pre- and Post-Dose

OD OSPre-Dose Pupil Size (mm) 7.5 7.8

LCVA 20/53 20/53

Ability to See?

Post-Dose Pupil Size (mm) 5.2 5.1

LCVA 20/17 20/15

Change in Ability to See?

Lot of difficulty

Much better

OD OSPre-Dose Pupil Size (mm) 7.5 7.8

LCVA 20/53 20/53

Ability to See?

Post-Dose Pupil Size (mm) 5.2 5.1

LCVA 20/17 20/15

Change in Ability to See?

Lot of difficulty

Much better


Contrast Sensitivity Methodology


Contrast Sensitivity Subject 002 ODFACT Pre Dose FACT Post-Dose


Contrast Sensitivity Subject 002 OSFACT Pre Dose FACT Post Dose


• Subject 002 went from being functionally blind at night to being able to see well

• Substantial improvement in all measures– Contrast Sensitivity Well below normal to high normal

Exceeds FDA efficacy criteria

– LCVA 20/53 to 20/17 or better– Snellen acuity 1 line of improvement– Subjective “Lot of difficulty” to “much better”

Nyxol Eye Drops: OP-NYX-SNV Subject 002


OP-NYX-SNV StudyContrast Sensitivity – Active Pre vs Post

0

1

2

3

4

5

6

7

1.5 3 6 12 18

Pre

Post

Spatial Frequency – Cycles/DegreeSpatial Frequency – Cycles/Degree

Pat

ch U

nit

sP

atch

Un

its

P < .05P < .05

P < .001P < .001

P < .05P < .05

P < .001P < .001

P < .001P < .001


Contrast Sensitivity Active Subjects FACT Pre-Dose FACT Post-Dose


Contrast Sensitivity Active Subjects45 & Under

FACT Pre Dose FACT Post Dose


Individual Subject AnalysisChange in FACT Patch Units

Contrast Sensitivity - Active

-3

-2

-1

0

1

2

3

4

5

6

7

8

1 2 3 4 5

Frequencies

Del

ta P

atch

es-P

re v

s P

ost

Contrast Sensitivity - Placebo

-3

-2

-1

0

1

2

3

4

5

6

7

8

1 2 3 4 5

Frequencies

Del

ta P

atch

es-P

re v

s P

ost


Mesopic Low Contrast Visual Acuity

0

2

4

6

8

10

12

Pre vs Post Active vs Placebo Pre vs Post <45

Ch

ang

e in

Let

ters

Rea

dC

han

ge

in L

ette

rs R

ead

p < .001p < .001

p < .05p < .05

p < .001p < .001


Wavefront Acuity Map RMS Error

0

0.25

0.5

0.75

1

1.25

1.5

Placebo Active

Pre

Post

P < .001P < .001 NS NS

RM

S E

rro

r U

nit

s µ

RM

S E

rro

r U

nit

s µ


Subjective Change in Night Vision

0%

20%

40%

60%

80%

100%

MuchBetter

Better Same Worse MuchWorse

Placebo

Active


Reduction in Pupil Diameter

0.00

0.25

0.50

0.75

1.00

1.25

1.50

Pre vs Post Active vs Placebo

Red

uct

ion

in P

up

il D

iam

mm

Red

uct

ion

in P

up

il D

iam

mm p < .0001 p < .0001

p<.0001 p<.0001


Redness

None

Trace

Slight

Moder-

Severe

NS

p<0.001

Placebo Active 0

25

50

75

100

Units0-100

Pre

Post


Intraocular Pressure

0

2

4

6

8

10

12

14

Placebo Active

Pre

Post

P < .001P < .001 NS NS

IOP

mm

Hg

IOP

mm

Hg


Systolic Blood Pressure

0

25

50

75

100

125

150

Placebo Active

Pre

PostBP

mm

Hg

BP

mm

Hg


Diastolic Blood Pressure

0

20

40

60

80

100

Placebo Active

Pre

Post

BP

mm

Hg

BP

mm

Hg


OP-NYX-SNV

• Study Summary– Nyxol Eye Drops improve night vision

• Clinically meaningful• Statistically significant

– Results consistent across all endpoints• Contrast Sensitivity• High & Low Contrast Visual Acuity• Wavefront• Subjective questionnaire• Pupil size

– Nyxol Eye Drops safe and well tolerated


Ocularis Pharma

Appendix 4

NOVA Study Results


Night Optics and Vision Assessment (NOVA) Study Design

• Non-therapeutic epidemiological study• 100 subjects (20 in each of 5 groups) with complaints of

night vision disturbances– Post refractive surgery– High myopia/astigmatism– Contact lens wearers– Glasses only at night– Cataracts

• Endpoints measured prior to and during illumination of the contralateral eye (consensual pupillary light reflex)– Pupil diameter– High and low contrast visual acuity– Subjective questionnaire


NOVA Study Result

• 4 of 5 groups show significant improvement with smaller pupils in dim light– Post refractive surgery– High myopia/astigmatism– Contact lens wearers– Glasses only at night (night myopia)

• Small fraction of cataract patients reported improvement


NOVA StudySmaller Pupils Improve Night Vision


NOVA StudySmaller Pupils Improve Visual Acuity


Population Study Design• Epidemiological study

• Objectives are to determine– Incidence of night vision disturbances in the normal population– Spectrum of severity of night vision disturbances– Benefit derived from making pupils smaller

• Endpoints measured prior to and during illumination of the contralateral eye (consensual pupillary light reflex)– Contrast sensitivity– High and low contrast visual acuity– Pupil size – Subjective questionnaire

• Study size, centers, timing - TBD


Ocularis Pharma

Appendix 5

Optometrist Survey Results


Optometrist Night Vision Survey

• 13 questions asked on optometrist experience with night vision complaints

• 35 optometrists in Milwaukee area surveyed• Conducted by Milwaukee Market Research• Completed March, 2008


Average Patients Seen Per Month

0

50

100

150

200

250

300

Survey National Average


Services Provided

79%

9%

4%

3% 5%

Eyeglasses/Contacts

Allergy/Dry Eye

Glaucoma

Pre/Post Surgery

Other


Night Vision Complaints

0%

5%

10%

15%

20%

25%

30%

Unprompted Prompted


Symptoms Cited by Patients with NVCs

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

NightDriving

Difficulty

Glare Halos Starbursts Sensitivity DepthPerception

Ghosting


Potential Causes of NVCs

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

NightMyopia

Cataracts Dry Eye Post-LASIK

Post-IOL Back ofthe Eye


What Drugs Do ODs Prescribe

0%

10%

20%

30%

40%

50%

60%

70%

80%

Alphagan P Pilocarpine Artificial Tears None


What Devices Do ODs Prescribe

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Eyeglasses TintedGlasses

Anti ReflectiveCoating

Look Away


What Percent Would Benefit?What Percent Would OD Prescribe?

0%

5%

10%

15%

20%

25%

30%

35%

40%

% Benefit % Prescribe


Price and Prescriber

• Price– Our market model assumes $13 per month– Survey says patients would pay $24 per month for this product,

almost double our assumed price

• Likely Prescribers1 Optometrist

2 Refractive Surgeon

3 Ophthalmologist


Optometrist Survey Summary• 28% of patients would complain about night

vision, if asked• Treat NVCs with drugs

– 70+% Artificial tears– <25% Glaucoma meds with pupil reduction side effect

• Treat NVCs with devices– 45% Eyeglasses– 45% Antireflective coating– 26% Tinted glasses

• Who would benefit from Nyxol™ Eye Drops?– 35% of NVC sufferers

• Who would get Nyxol scrips?– 39% of NVC sufferers


Ocularis Pharma

Appendix 6

Recent Phentolamine Approval


Novalar Pharma & Phentolamine Mesylate

• Novalar Pharma– San Diego based, founded in 2000– Financed by Domain, NEA, SR One and Montreux– Focused on drugs for dentristry

• OraVerse® for Injection (phentolamine mesylate)– Approved for use by FDA May, 2008– Indicated for reversal of dental anesthesia– Labeled for adults and pediatrics (>6 years old)– Lifestyle drug, reduces time of numbness by 50%– 4 use patents, 1 formulation patent– Will launch in October, 2008 with own sales/marketing team– Injectable dosage form distinct from Nyxol® Eye Drops


Implications for Nyxol® Eye Drops Program

• Novalar’s success with OraVerse demonstrates phentolamine mesylate can be:– Formulated in solution with 3 year stability

– Manufactured (API and drug product) under cGMP

– Shown to be safe in animals and man• Approved for adults and children (6 and older)• FDA required tox and safety to be “squeaky clean” for

approval of this lifestyle drug

– Approved by FDA under modern regulations (last approved in 1952)

Conclusion: Results in a major reduction in risk, cost and time to

market for Nyxol Eye Drops development


Phentolamine MesylateComparison of Dosage Forms & Systemic Safety

Conclusion: Nyxol Eye Drops should have systemic safetybetter than or equal to OraVerse

Conclusion: Nyxol Eye Drops should have systemic safetybetter than or equal to OraVerse

Nyxol® Eye Drops OraVerse® Injection Regitine® Injection

Indication Treatment of Reversal of Diagnosis ofnight vision complaints dental anesthesia pheochromocytoma

Concentration 1.0% solution 0.0235% solution 0.5% solution10 mg/mL 0.235 mg/mL 5 mg/mL

Route of Admin Corneal surface Submucosal Intravenous

Delivered Dose 1.0 mg 0.4 mg 5.0 mg

Systemic Take Up % 10% (est) 100% 100%Systemic Dose 0.1 mg 0.4 mg 5.0 mg

Fraction of IV Dose % 2% 8% 100%


Ocularis Pharma

Appendix 7

Clinical Study: HOA Analysis


HOA AnalysisAvg Change Pre- to Post- Drug

Ocularis Presentation 0908[2]

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