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Ocularis Presentation 0908[2]
- 2. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 2
- 3. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 3
- 4. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 4
- 5. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 5
- 6. Nyxol Eye Drops to Treat Night Vision Complaints
Typical Night Vision Disturbance Clear Night Vision
© 2008 Ocularis Pharma - Confidential March, 2008 Page 6
- 7. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 7
- 8. Nyxol Eye Drops: Manage Pupil Dilation
● Mechanism of Action
– Alpha 1 antagonist
– Inhibits iris dilator muscle
– Limits pupil dilation
Typical Managed
Dilation Dilation
© 2008 Ocularis Pharma - Confidential March, 2008 Page 8
- 9. Nyxol Eye Drops: Manage Pupil Dilation
Before After
© 2008 Ocularis Pharma - Confidential March, 2008 Page 9
- 10. Nyxol Eye Drops: Drug Profile
• 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 10
- 11. Nyxol Eye Drops: Milestones Achieved
• 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)
© 2008 Ocularis Pharma - Confidential March, 2008 Page 11
- 12. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 12
- 13. Nyxol Eye Drops: Milestones Achieved
• 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 13
- 14. Nyxol Eye Drops: Development Plan
Overview
• 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 14
- 15. Nyxsol Recent Milestone
• Received Term Sheet From Major
Pharmaceutical Company For $28M
© 2008 Ocularis Pharma - Confidential March, 2008 Page 15
- 16. Nyxol Eye Drops: 2009 - 2010
• 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.
© 2008 Ocularis Pharma - Confidential March, 2008 Page 16
- 17. Comparable Phase 3 Programs
Product Nyxol® Restasis® Alphagan P®
Moderate to
Moderate to Open Angle
Indication Severe Dry
Severe NVC Glaucoma
Eye
# of
Patients 1,000 1,200 926
Duration 6 months 6 months 1 year
© 2008 Ocularis Pharma - Confidential March, 2008 Page 17
- 18. 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 company
Alcon AMO
Allergan Bausch & Lomb
© 2008 Ocularis Pharma - Confidential March, 2008 Page 18
- 19. 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 plan
Low cost / Low risk / Fast to market
• Clear Exit Strategy
© 2008 Ocularis Pharma - Confidential March, 2008 Page 19
- 20. Ocularis Pharma
Appendices
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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 20
- 22. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 22
- 23. Bausch & Lomb Introduces
New 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 23
- 24. “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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 24
- 25. 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%
© 2008 Ocularis Pharma - Confidential March, 2008 Page 25
- 26. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 26
- 27. Younger vs Older Drivers in the Dark
18-49 50+
• Difficulty driving in the dark 36% 22%
• Hard time seeing signs & exits 30% 17%
© 2008 Ocularis Pharma - Confidential March, 2008 Page 27
- 28. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 28
- 30. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 30
- 31. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 31
- 32. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 32
- 33. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 33
- 34. Night Vision Complaint Market
Moderate/Severe NVC Market Segments
Night Myopia (Non-Surgical) $327 mm
Post-Surgical $95 mm
IOLs & LASIK
Total $422 mm
© 2008 Ocularis Pharma - Confidential March, 2008 Page 34
- 35. Night Vision Complaint Market:
Night Myopia Market Potential
Night
Myopia
(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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 35
- 36. Night Vision Complaint Market:
Summary Market Potential
Nyxol Market Potential 2015 (000's)
Night Post Surgical
Myopia 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 36
- 37. Fejer Study - 1992: Incidence of “Night Myopia”
• 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
Incidence Est Avg
of 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 37
- 38. Night Vision Complaints
Results of Initial Optometrist Survey
• Incidence of NVCs
– Patients complain about night vision
• Unprompted 20%
• Prompted >20%
© 2008 Ocularis Pharma - Confidential March, 2008 Page 38
- 39. Night Vision Complaints
Results of Initial Optometrist Survey
• 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 39
- 40. Night Vision Complaints
Results of Initial Optometrist Survey
• 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 40
- 41. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 41
- 42. Nyxol Eye Drops: Competition
• 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 42
- 44. Nyxol Eye Drops: OP-NYX-SNV
Latest Study Completed – 10/08
• 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 44
- 45. Nyxol Eye Drops: OP-NYX-SNV
• 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 45
- 46. Preliminary Analysis 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 46
- 47. Nyxol Eye Drops: OP-NYX-SNV
Subject 002 Demographics
• Female, 38 years old, night myopia (no surgery)
• Night vision problems
– Glare
– Halos
– Depth perception
• Limits night driving
© 2008 Ocularis Pharma - Confidential March, 2008 Page 47
- 48. OP-NYX-SNV: Subject 002
Pre- and Post-Dose
OD OS
Pre-Dose
Pupil Size (mm) 7.5 7.8
LCVA 20/53 20/53
Ability to See? Lot of difficulty
Post-Dose
Pupil Size (mm) 5.2 5.1
LCVA 20/17 20/15
Change in Ability to See? Much better
© 2008 Ocularis Pharma - Confidential March, 2008 Page 48
- 52. Nyxol Eye Drops: OP-NYX-SNV Subject 002
• 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”
© 2008 Ocularis Pharma - Confidential March, 2008 Page 52
- 53. OP-NYX-SNV Study
Contrast Sensitivity – Active Pre vs Post
P < .05 P < .05
7
6 P < .001
5
Patch Units
4 P < .001
Pre
3 P < .001 Post
2
1
0
1.5 3 6 12 18
Spatial Frequency – Cycles/Degree
© 2008 Ocularis Pharma - Confidential March, 2008 Page 53
- 55. Contrast Sensitivity Active Subjects
45 & Under
FACT Pre Dose FACT Post Dose
© 2008 Ocularis Pharma - Confidential March, 2008 Page 55
- 56. Individual Subject Analysis
Change in FACT Patch Units
Contrast Sensitivity - Active Contrast Sensitivity - Placebo
8 8
7 7
6 6
5 5
Delta Patches-Pre vs Post
Delta Patches-Pre vs Post
4 4
3 3
2 2
1 1
0 0
1 2 3 4 5 1 2 3 4 5
-1 -1
-2 -2
-3 -3
Frequencies Frequencies
© 2008 Ocularis Pharma - Confidential March, 2008 Page 56
- 57. Mesopic Low Contrast Visual Acuity
p < .001
12
p < .001
10
Change in Letters Read
8 p < .05
6
4
2
0
Pre vs Post Active vs Placebo Pre vs Post <45
© 2008 Ocularis Pharma - Confidential March, 2008 Page 57
- 58. Wavefront Acuity Map RMS Error
NS
P < .001
1.5
1.25
RMS Error Units µ
1
0.75 Pre
Post
0.5
0.25
0
Placebo Active
© 2008 Ocularis Pharma - Confidential March, 2008 Page 58
- 59. Subjective Change in Night Vision
100%
80%
60%
Placebo
40%
Active
20%
0%
Much Better Same Worse Much
Better Worse
© 2008 Ocularis Pharma - Confidential March, 2008 Page 59
- 60. Reduction in Pupil Diameter
1.50 p < .0001
p<.0001
Reduction in Pupil Diam mm
1.25
1.00
0.75
0.50
0.25
0.00
Pre vs Post Active vs Placebo
© 2008 Ocularis Pharma - Confidential March, 2008 Page 60
- 61. Redness
Severe 100
Moder- 75
NS p<0.001
Pre
Slight
Units 50 Post
0-100
25
Trace
None 0
Placebo Active
© 2008 Ocularis Pharma - Confidential March, 2008 Page 61
- 62. Intraocular Pressure
NS P < .001
14
12
10
IOP mm Hg
8
Pre
6 Post
4
2
0
Placebo Active
© 2008 Ocularis Pharma - Confidential March, 2008 Page 62
- 63. Systolic Blood Pressure
150
125
100
BP mm Hg
75 Pre
Post
50
25
0
Placebo Active
© 2008 Ocularis Pharma - Confidential March, 2008 Page 63
- 64. Diastolic Blood Pressure
100
80
BP mm Hg
60
Pre
40 Post
20
0
Placebo Active
© 2008 Ocularis Pharma - Confidential March, 2008 Page 64
- 65. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 65
- 67. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 67
- 68. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 68
- 71. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 71
- 73. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 73
- 74. Average Patients Seen Per Month
300
250
200
150
100
50
0
Survey National Average
© 2008 Ocularis Pharma - Confidential March, 2008 Page 74
- 75. Services Provided
3% 5%
4%
9%
Eyeglasses/Contacts
Allergy/Dry Eye
Glaucoma
Pre/Post Surgery
Other
79%
© 2008 Ocularis Pharma - Confidential March, 2008 Page 75
- 77. Symptoms Cited by Patients with NVCs
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Night Glare Halos Starbursts Sensitivity Depth Ghosting
Driving Perception
Difficulty
© 2008 Ocularis Pharma - Confidential March, 2008 Page 77
- 78. Potential Causes of NVCs
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Night Cataracts Dry Eye Post- Post-IOL Back of
Myopia LASIK the Eye
© 2008 Ocularis Pharma - Confidential March, 2008 Page 78
- 79. What Drugs Do ODs Prescribe
80%
70%
60%
50%
40%
30%
20%
10%
0%
Alphagan P Pilocarpine Artificial Tears None
© 2008 Ocularis Pharma - Confidential March, 2008 Page 79
- 80. What Devices Do ODs Prescribe
50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
Eyeglasses Tinted Anti Reflective Look Away
Glasses Coating
© 2008 Ocularis Pharma - Confidential March, 2008 Page 80
- 81. What Percent Would Benefit?
What Percent Would OD Prescribe?
40%
35%
30%
25%
20%
15%
10%
5%
0%
% Benefit % Prescribe
© 2008 Ocularis Pharma - Confidential March, 2008 Page 81
- 82. 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 Prescribers
1 Optometrist
2 Refractive Surgeon
3 Ophthalmologist
© 2008 Ocularis Pharma - Confidential March, 2008 Page 82
- 83. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 83
- 85. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 85
- 86. 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
© 2008 Ocularis Pharma - Confidential March, 2008 Page 86
- 87. Phentolamine Mesylate
Comparison of Dosage Forms & Systemic Safety
Nyxol® Eye Drops OraVerse® Injection Regitine® Injection
Indication Treatment of Reversal of Diagnosis of
night vision complaints dental anesthesia pheochromocytoma
Concentration 1.0% solution 0.0235% solution 0.5% solution
10 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%
Conclusion: Nyxol Eye Drops should have systemic safety
better than or equal to OraVerse
© 2008 Ocularis Pharma - Confidential March, 2008 Page 87