Ocularis Presentation 0908[2]

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Updated presentation on first drop for improvement of night vision.

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Ocularis Presentation 0908[2]

  1. 1. July 12, 2009 Confidential
  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. 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. 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. 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. 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. 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. 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. 9. Nyxol Eye Drops: Manage Pupil Dilation Before After © 2008 Ocularis Pharma - Confidential March, 2008 Page 9
  10. 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. 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. 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. 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. 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. 15. Nyxsol Recent Milestone • Received Term Sheet From Major Pharmaceutical Company For $28M © 2008 Ocularis Pharma - Confidential March, 2008 Page 15
  16. 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. 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. 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. 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. 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
  21. 21. Ocularis Pharma Appendix 1 Recent Night Vision Market Developments © 2008 Ocularis Pharma - Confidential March, 2008 Page 21
  22. 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. 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. 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. 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. 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. 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. 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
  29. 29. Ocularis Pharma Appendix 2 Night Vision Complaint Market © 2008 Ocularis Pharma - Confidential March, 2008 Page 29
  30. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  43. 43. Ocularis Pharma Appendix 3 Nyxol – Results of Recent Phase II Trial © 2008 Ocularis Pharma - Confidential March, 2008 Page 43
  44. 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. 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. 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. 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. 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
  49. 49. Contrast Sensitivity Methodology © 2008 Ocularis Pharma - Confidential March, 2008 Page 49
  50. 50. Contrast Sensitivity Subject 002 OD FACT Pre Dose FACT Post-Dose © 2008 Ocularis Pharma - Confidential March, 2008 Page 50
  51. 51. Contrast Sensitivity Subject 002 OS FACT Pre Dose FACT Post Dose © 2008 Ocularis Pharma - Confidential March, 2008 Page 51
  52. 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. 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
  54. 54. Contrast Sensitivity Active Subjects FACT Pre-Dose FACT Post-Dose © 2008 Ocularis Pharma - Confidential March, 2008 Page 54
  55. 55. Contrast Sensitivity Active Subjects 45 & Under FACT Pre Dose FACT Post Dose © 2008 Ocularis Pharma - Confidential March, 2008 Page 55
  56. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  66. 66. Ocularis Pharma Appendix 4 NOVA Study Results © 2008 Ocularis Pharma - Confidential March, 2008 Page 66
  67. 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. 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
  69. 69. NOVA Study Smaller Pupils Improve Night Vision © 2008 Ocularis Pharma - Confidential March, 2008 Page 69
  70. 70. NOVA Study Smaller Pupils Improve Visual Acuity © 2008 Ocularis Pharma - Confidential March, 2008 Page 70
  71. 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
  72. 72. Ocularis Pharma Appendix 5 Optometrist Survey Results © 2008 Ocularis Pharma - Confidential March, 2008 Page 72
  73. 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. 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. 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
  76. 76. Night Vision Complaints 30% 25% 20% 15% 10% 5% 0% Unprompted Prompted © 2008 Ocularis Pharma - Confidential March, 2008 Page 76
  77. 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. 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. 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. 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. 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. 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. 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
  84. 84. Ocularis Pharma Appendix 6 Recent Phentolamine Approval © 2008 Ocularis Pharma - Confidential March, 2008 Page 84
  85. 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. 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. 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
  88. 88. Ocularis Pharma Appendix 7 Clinical Study: HOA Analysis © 2008 Ocularis Pharma - Confidential March, 2008 Page 88
  89. 89. HOA Analysis Avg Change Pre- to Post- Drug © 2008 Ocularis Pharma - Confidential March, 2008 Page 89

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