Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Investor Day (October 2017)
127 slides from Aldeyra Therapeutics's investor day presentation, Oct 10, 2017
Slide 1: 2017 Research and Development Day
2017 Research and Development Day October 10, 2017 Exhibit 99.1
Slide 2: Disclaimers and Forward-Looking Statements
Disclaimers and Forward-Looking Statements This presentation and various remarks which may be made during this presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended
Slide 3: Aldeyra Therapeutics 2017 Research and Development Day
Aldeyra Therapeutics 2017 Research and Development Day New Results from Phase 2 Clinical Trials in Allergic Conjunctivitis and Dry Eye Disease David Clark, MD, Chief Medical Officer, Aldeyra Unmet Medical Need in Allergic Conjunctivitis and Dry Eye Disease Tim Surgenor, RedSky Partners, LLC Clinical
Slide 4: Clinically Important Response Results from Phase 2b Clinical Trial in Allergic Conjunctivitis
Clinically Important Response Results from Phase 2b Clinical Trial in Allergic Conjunctivitis David Clark, MD Chief Medical Officer Aldeyra Therapeutics
Slide 5: Allergic Conjunctivitis Phase 2b Clinical Design
Allergic Conjunctivitis Phase 2b Clinical Design Groups Topical Ocular ADX-102 0.1%, ADX-102 0.5%, or Vehicle Randomization Double-Masked, Vehicle-Controlled 1:1:1 Enrollment 154 Patients with History of Allergic Conjunctivitis Model Single Dose Seasonal and Perennial Allergen Challenge Endpoint Pat
Slide 6: Histaminic and Aldehyde-Mediated Phases After Allergen Challenge
Histaminic and Aldehyde-Mediated Phases After Allergen Challenge Histaminic Phase Aldehyde-Mediated Phase (Cells, cytokines, and other aldehyde-stimulated factors) In Phase 2 clinical trials, ADX-102 shown to be effective for aldehyde-mediated allergy, for which no drug is approved, and which affect
Slide 7: Activity of Antihistamines Diminishes Rapidly as ADX-102 Activity Increases
The Activity of Antihistamines Diminishes Rapidly as ADX-102 Activity Increases Data from olopatadine Summary Basis of Approval, ADX-102 Phase 2b clinical trial.
Slide 8: ADX-102 Decreased Ocular Itch in Phase 2b Clinical Trial
ADX-102 Decreased Ocular Itch in Phase 2b Clinical Trial ADX-102 was statistically superior to control in reducing allergic ocular itch 10 to 60 minutes after allergen challenge, when the activity of antihistamines diminishes.
Slide 9: ADX-102 Decreased Area Under the Curve Ocular Itch Score
ADX-102 Decreased Area Under the Curve Ocular Itch Score in Phase 2b Clinical Trial Area under the curve indicated a durable effect of ADX-102 in reducing ocular itch score in a manner that is statistically superior to that of control 10 to 60 minutes after allergen challenge, when the activity of a
Slide 10: Probability of Clinically Important Response Statistically Higher in ADX-102-Treated Patients
Probability of Clinically Important Response Was Statistically Higher in ADX-102-Treated Patients One-point improvement in ocular itch score is US FDA regulatory precedent When a responder is defined as a patient that improves one point from peak baseline itch score, odds ratio analysis indicated th
Slide 11: Clinical Response Achieved Faster in ADX-102 Group vs. Vehicle
Clinical Response Achieved Faster in ADX-102 Group vs. the Vehicle Group 0.1% and 0.5% ADX-102 groups achieved statistically faster clinical response than vehicle (p=0.0006 and p=0.008, respectively). As an example, the graph to the right indicates that 94% of 0.1% ADX-102-treated patients responded
Slide 12: Allergic Conjunctivitis Phase 2b Key Conclusions
Allergic Conjunctivitis Phase 2b Key Conclusions ADX-102 was shown to be statistically superior to vehicle in durably reducing ocular itch score from 10 to 60 minutes after exposure to allergen, an efficacy profile that has not been demonstrated for antihistamines. Relative to control, the activity
Slide 13: Allergic Conjunctivitis Phase 3 Clinical Design
Allergic Conjunctivitis Phase 3 Clinical Design Groups Topical Ocular ADX-102 0.1%, ADX-102 0.5%, or Vehicle Randomization Double-Masked, Vehicle-Controlled 1:1:1 Enrollment 150 Patients with History of Allergic Conjunctivitis Model Single Dose Seasonal Allergen Challenge Endpoint Patient-Reported I
Slide 14: A Market-Based Analysis of Unmet Medical Need in Allergic Conjunctivitis and Dry Eye Disease
A Market-Based Analysis of Unmet Medical Need in Allergic Conjunctivitis and Dry Eye Disease Tim Surgenor 617-584-2638 tsurgenor@redskyco.com Cambridge Innovation Center One Broadway, 4th Floor Cambridge, MA 02142 The opinions expressed herein are those of RedSky Partners, LLC and do not necessarily
Slide 15: Overview
Overview ADX-102, if approved, has potential to be differentiated, branded entry in market for eye drop treatments ADX-102 appears to provide clinically significant improvement in phase 2 studies in multiple indications allergic conjunctivitis dry eye disease noninfectious anterior uveitis Positioni
Slide 16: US Eye Drop Market in 2016
US Eye Drop Market in 2016 Source: IMS
Slide 17: Emerging Value Proposition – ADX-102
Emerging Value Proposition – ADX-102 Noninfectious Anterior Uveitis Dry Eye Allergic Conjunctivitis Market Need ~150,000 US patients Treated with corticosteroids, which may lead to cataracts and glaucoma ~20 million patients Only two approved drugs Therapy generally considered to be inadequate ~20%
Slide 18: ADX-102 Opportunity in Allergic Conjunctivitis
ADX-102 Opportunity in Allergic Conjunctivitis Allergic conjunctivitis – inflammatory disease of conjunctiva resulting from allergen exposure Affects ~20% of US population with range of severity Mast-cell stabilizers or antihistamines provide short term relief –acute phase allergic reaction (up to 2
Slide 19: Survey Overview
Survey Overview Survey of 75 US Physicians Ophthalmology - 45 Optometry - 15 Allergy / Immunology - 15 Conducted in July 2017 on behalf of Aldeyra Active in treatment of allergic conjunctivitis Source: GLG market research
Slide 20: How do you currently treat your AC patients with topical products?
How do you currently treat your AC patients with topical products? Source: GLG market research
Slide 21: Percent of AC patients on topical antihistamines by category
For AC patients treated with topical ophthalmic antihistamines, what percent apply to each category below? Source: GLG market research
Slide 22: Cross-sectional study of allergic conjunctivitis consistent with survey results
Cross-sectional study of allergic conjunctivitis consistent with survey results 2015 Study in Italy 2687 Allergic conjunctivitis patients 43% used OTC 29% used topical antihistamines 41% used corticosteroids 60% used multiple medications Source: Allergic conjunctivitis: a cross-sectional study; A. L
Slide 23: Symptom relief categories after single antihistamine dose
What percentage of your AC patients on anti-histamines, after a single dose, fall into the following categories of symptom relief? Source: GLG market research
Slide 24: AC patients with mixed condition
What percentage of your AC patients have some type of mixed condition? Source: GLG market research
Slide 25: 2011 Study of allergic conjunctivitis and dry eye syndrome
2011 Study of allergic conjunctivitis patients and dry eye syndrome consistent with survey results M.M. Hom et al. / Ann Allergy Asthma Immunol 108 (2012) 163–166 Dry Eye Patients (Dryness) Allergic Conjunctivitis (Itch) 45% of Allergic Conjunctivitis Patients with Itch Symptoms Also Experience Dryn
Slide 26: Candidates for a safe non-steroidal anti-inflammatory product
If a safe, non-steroidal, anti-inflammatory product was available that provided a more sustained symptomatic response than antihistamines, what percent of your AC patients would be candidates for this therapy? Source: GLG market research
Slide 27: Conclusions – ADX-102 differentiated profile in allergic conjunctivitis
Conclusions – ADX-102 has potential for differentiated profile in allergic conjunctivitis treatment ADX-102 has a novel therapeutic profile In Phase 2 clinical trials, the largest reduction in itching occured after typical antihistamine peak activity This observation consistent with effect on aldehy
Slide 28: Additional Data on Aldehyde Biomarker Correlation with Clinical Efficacy from Phase 2a Dry Eye
Additional Data on Aldehyde Biomarker Correlation with Clinical Efficacy from Phase 2a Dry Eye Disease Clinical Trial David Clark, MD Chief Medical Officer Aldeyra Therapeutics
Slide 29: Dry Eye Disease Phase 2a Clinical Design
Dry Eye Disease Phase 2a Clinical Design Groups Topical Ocular ADX-102 Formulations: 0.1% ADX-102 0.5% ADX-102 0.5% (Lipid) ADX-102 Randomization 1:1:1 28-Day Four-Times-Daily Dosing Enrollment 51 Patients with Dry Eye Disease Primary Objective Dose Selection for Phase 2b Based on Tolerability and E
Slide 30: Statistically Significant Improvement in Multiple Dry Eye Signs and Symptoms
Statistically Significant Improvement in Multiple Dry Eye Disease Signs and Symptoms Endpoint (Pooled Data) Pre-Treatment Post-Treatment p value* Symptom Assessment in Dry Eye (SANDE) Score 61 52 p = 0.003 Ocular Discomfort Score 2.3 1.5 p = 0.00002 Overall 4-Symptom Score 2.6 2.0 p = 0.0004 Tear Vo
Slide 31: Symptom Improvement Over Time
Symptom Improvement Over Time Supportive of Drug Activity Pooled data from ADX-102 Phase 2a clinical trial.
Slide 32: Improvement Effect Sizes Robust and Statistically Significant
Improvement Effect Sizes Were Robust and Statistically Significant p values are subject to change based on quality control analysis; Effect size = Mean difference from Day 0 to Day 28 / Standard Deviation of Day 0. Data from ADX-102 Phase 2a clinical trial.
Slide 33: Dose Response in Phase 2a Dry Eye Disease Clinical Trial
Dose Response in Phase 2a Dry Eye Disease Clinical Trial
Slide 34: Tear Aldehyde Reduction Supportive of Aldehyde Sequestering Mechanism
Tear Aldehyde Reduction Supportive of ADX-102 Aldehyde Sequestering Mechanism p values are subject to change based on quality control analysis; Pre-Treatment = Day 0, Post-Treatment = Day 28; pooled data from Phase 2a clinical trial. Statistically significant aldehyde reduction occurred in conjuncti
Slide 35: Aldehyde Reduction Correlated with Sign Improvement Within Individual Patients
Aldehyde Reduction Correlated with Sign Improvement Within Individual Patients p values are subject to change based on quality control analysis; pooled data from Phase 2a clinical trial. Patients with the most reduction in aldehyde levels also exhibited greater corneal staining improvement, suggesti
Slide 36: Aldehyde Reduction Correlated with Sign Improvement Within Individual Patients
Aldehyde Reduction Correlated with Sign Improvement Within Individual Patients p value vs. baseline is subject to change based on quality control analysis; pooled data from Phase 2a clinical trial. Patients with the most reduction in aldehyde levels also exhibited greater tear osmolarity improvement
Slide 37: Dry Eye Disease Expected Phase 2b Clinical Design
Dry Eye Disease Expected Phase 2b Clinical Design* Groups 0.1% ADX-102, 0.25% ADX-102, and Control Randomization 1:1:1 Double-Masked Treatment Time 12 Weeks Enrollment 225 Patients with Dry Eye Disease Endpoints Standard Dry Eye Disease Signs and Symptoms *Pending additional non-clinical data and ot
Slide 38: Clinical and Regulatory Opportunities in Treatment of Dry Eye Disease
Clinical and Regulatory Opportunities in Treatment of Dry Eye Disease Gary D. Novack, Ph.D. October 2017 (C) 2017 PharmaLogic Development, Inc. The opinions expressed herein are those of Dr. Novack and do not necessarily reflect the views of Aldeyra.
Slide 39: Disclosures
Disclosures Dr. Novack consults for numerous pharmaceutical and medical device firms. (C) 2017 PharmaLogic Development, Inc.
Slide 40: (C) 2017 PharmaLogic Development, Inc.
(C) 2017 PharmaLogic Development, Inc.
Slide 41: (C) 2017 PharmaLogic Development, Inc.
(C) 2017 PharmaLogic Development, Inc.
Slide 42: Dry eye disease
Dry eye disease Dry eye disease KCS King Charles Spaniel Keratoconjunctivitis sicca Misnomer Implies aqueous deficiency – which is only part of dry eye (C) 2017 PharmaLogic Development, Inc.
Slide 43: Tear film
Willcox MDP et al TFOS DEWS II Tear Film Report. Ocul Surf 2017;15(3): 366-403. Tear film (C) 2017 PharmaLogic Development, Inc.
Slide 44: Source of Tears: Aqueous
Source of Tears: Aqueous (C) 2017 PharmaLogic Development, Inc.
Slide 45: Source of Tears: Mucin
Source of Tears: Mucin (C) 2017 PharmaLogic Development, Inc.
Slide 46: Source of Tears: Lipid
Source of Tears: Lipid (C) 2017 PharmaLogic Development, Inc.
Slide 47: DEWS II definition of dry eye
“Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.”
Slide 48: TFOS DEWS II Definition and Classification
(C) 2017 PharmaLogic Development, Inc. Craig, JP et al. TFOS DEWS II Definition and Classification Report. Ocul Surf 2017;15(3): 276-283.
Slide 49: Treatments
Treatments (C) 2017 PharmaLogic Development, Inc.
Slide 50: Treatment recommendations
(C) 2017 PharmaLogic Development, Inc. Treatment recommendations Diagrammatic representation of the process associated with the management of DED
Slide 51: Step 1 treatments for dry eye
Step 1 Education regarding the condition, its management, treatment and prognosis Modification of local environment Education regarding potential dietary modifications (including oral essential fatty acid supplementation) Identification and potential modification/elimination of offending systemic an
Slide 52: Step 2 prescription drugs to manage DED
Step 2 Prescription drugs to manage DED Topical antibiotic or antibiotic/steroid combination applied to the lid margins for anterior blepharitis (if present) Topical corticosteroid (limited-duration) Topical secretagogues Topical non-glucocorticoid immunomodulatory drugs (such as cyclosporine) Topic
Slide 53: Investigational Rx Phase 3
Investigational Rx Phase 3: Loteprednol etabonate nanoparticles (Kala) Tavilermide (Mimetogen / Allergan) Cyclosporine OTX-101 (Auven/SunPharma) Thymosin beta 4 – RegeneRx (C) 2017 PharmaLogic Development, Inc.
Slide 54: Investigational Rx Phase 2
Investigational Rx Phase 2: P-321 (Parion/Shire) Lubricin™ (Lubris/Novartis) Lacritin™ (Tear Solutions) ADX-102 (Aldeyra) (C) 2017 PharmaLogic Development, Inc.
Slide 55: Treatments for Tear Insufficiency
Tear replacement Artificial tears (lubricants) Aqueous supplements; Lipid supplements Biological supplements Autologous serum Tear conservation Punctal occlusion Moisture chamber spectacles Tear stimulation Topical secretagogues; Oral secretagogues; Nasal neurostimulation Treatments for Tear Insuffi
Slide 56: Ocular Lubricants
Ocular Lubricants (C) 2017 PharmaLogic Development, Inc. Mainstay of therapy numerous topical formulations available Avoid preservatives in severe dry eye Very few RCT have compared the relative superiority of a particular OTC product to others for DED
Slide 57: Anti-Inflammatory Therapy
Anti-Inflammatory Therapy Topical glucocorticoids Non-glucocorticoid immunomodulators Cyclosporine Tacrolimus NSAIDs Biologics LFA-1 antagonist (Lifitegrast) Inflammatory modulation with systemic & topical antibiotics tetracyclines Macrolide treatments (C) 2017 PharmaLogic Development, Inc.
Slide 58: Surgical Approaches
Surgical Approaches Tarsorrhaphy Surgical treatment for conjunctivochalasis Essential blepharospasm treatment with botulinum neurotoxin Lid corrections Dermatochalasis Blepharoptosis (ptosis) Lower lid blepharoplasty Conjunctival surgery and amniotic membrane grafts Mechanical dacryoreservoirs Major
Slide 59: Local Environmental Considerations
Local Environmental Considerations Chronic topical medications Systemic medications Decreased blink rate Desiccating conditions and environmental pollutants Contact lens wear (C) 2017 PharmaLogic Development, Inc.
Slide 60: US FDA: OTC Ophthalmic monograph
US FDA: OTC Ophthalmic monograph (C) 2017 PharmaLogic Development, Inc.
Slide 61: Pharmacotherapy: Approvals
Chao W. Report of the Inaugural Meeting of the TFOS i(2) = initiating innovation Series: Targeting the Unmet Need for Dry Eye Treatment." Ocul Surf 2016;14(2): 264-316. Pharmacotherapy: Approvals (C) 2017 PharmaLogic Development, Inc.
Slide 62: Xiidra
Xiidra® (C) 2017 PharmaLogic Development, Inc.
Slide 63: Indications of Restasis and Xiidra
Indications Restasis® (cyclosporine): to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Xiidra® (lifitegrast): For the treatment of the signs and symptoms of dry eye disease (C) 2017 Pharm
Slide 64: FDA clinical efficacy requirements
FDA clinical efficacy requirements Two studies (per 1962 law) Efficacy: One sign, one symptom Statistically significantly different from vehicle (or maybe) Non-inferior to approved product Safety: 300-500 subjects, 100 chronic (C) 2017 PharmaLogic Development, Inc.
Slide 65: Intersection of Dry Eye Disease and Allergic Conjunctivitis
Intersection of Dry Eye Disease and Allergic Conjunctivitis John D Sheppard, MD, MMSc Professor of Ophthalmology, Microbiology & Molecular Biology Clinical Director, Thomas Lee Ocular Pharmacology Laboratory Ophthalmology Residency Research Director Medical Director, Lions Eye Bank of Eastern Virgin
Slide 66: Dry Eye Prevalence and Growth
SARcode Confidential 2 Dry Eye Prevalence and Growth Dry eye prevalence estimates range from 14% to 33% of the general population 70% Female; 30% Males Common in Post-Menopausal Women Dry eye prevalence will continue its strong growth: Aging population Increasing visual tasking (computers, VDTs) Wor
Slide 67: Level I Dry Eye: DEWS Report
SARcode Confidential 4 Level I Dry Eye: DEWS Report
Slide 68: Level II Dry Eye: DEWS Report
SARcode Confidential 5 Level II Dry Eye: DEWS Report
Slide 69: Dry Eye Rx Landscape: Restasis
SARcode Confidential 6 Restasis ® (0.05% cyclosporine ophthalmic emulsion) Approved by FDA on 12/23/2002 Product Profile / Label: Indication for treatment of a sign only: increased tear production Onset of treatment effect: increased tear production observed after 6 months of treatment Effective in
Slide 70: Dry Eye Rx Landscape: Xiidra
SARcode Confidential 7 Dry Eye Rx Landscape: XiidraTM Xiidra ® (5% lifitegrast ophthalmic solution) Approved by FDA on July 11, 2016 Product Profile / Label: Indication for treatment of the signs and symptoms of dry eye disease Adverse effects in 5-25% of patients: Instillation site irritation, dysg
Slide 71: Dry Eye: A Fertile Landscape
SARcode Confidential 8 Large growing USA market with limited treatment options: Restasis® approved product in US (2016 sales ~$1.4 billion) Xiidra®approved product in the US (Aug-Dec 2016 ~ $54 million) Large growing International market with limited treatment options: Ciclosporin 0.1% emulsion (Mar
Slide 72: Dry Eye is an Inflammatory Condition
SARcode Confidential 10 Dry Eye is an Inflammatory Condition Well-supported in the Literature
Slide 73: Causes of Dry Eye
SARcode Confidential 11 Causes of Dry Eye Aqueous-Deficient Autoimmune disease (Sjögren’s Syndrome, RA, Lupus) Lipid-Deficient Meibomian gland dysfunction, Hormonal changes Mucin-Deficient Goblet cell loss Neural Loop-Associated Abnormal corneal sensitivity, Blink disorders Environmentally Induced o
Slide 74: Environmental Factors
SARcode Confidential 12 Environmental Factors
Slide 75: Corollary Factors
SARcode Confidential 13 Corollary Factors
Slide 76: Therapeutic Approaches Under Investigation
SARcode Confidential 14 Therapeutic Approaches Under Investigation Secretagogues Mucomimetics Hormonal Improved Polymers Anti-evaporatives Anti-Inflammatories Nutritional Supplements
Slide 77: Significant Need for New Therapies for Dry Eye Disease
SARcode Confidential 15 Significant Need for New Therapies for Dry Eye Disease Dry Eye Global Patient Population: 68 Million* Dry eye disease is one of the leading causes of patient visits to eye care professionals in the U.S. Standard of Care: OTC artificial tears Restasis® Off-label steroids Comme
Slide 78: Dry Eye Complications
SARcode Confidential 23 Dry Eye Complications Chronic Discomfort Foreign Body Sensation Visual Fluctuations Decreased Productivity Depression Contact Lens Intolerance Poor Surgical Predictability & Outcomes Infectious Keratitis
Slide 79: Severe Dry Eye with Filamentary Keratitis
SARcode Confidential 24 Severe Dry Eye with Filamentary Keratitis
Slide 80: SARcode
SARcode Confidential 25
Slide 81: SARcode
SARcode Confidential 26
Slide 82: Dry Eye & Rheumatoid Arthritis Peripheral Ulcerative Keratitis
SARcode Confidential 27 Dry Eye & Rheumatoid Arthritis Peripheral Ulcerative Keratitis
Slide 83: Herpetic Dendritic Keratitis
SARcode Confidential 28 Herpetic Dendritic Keratitis
Slide 84: SARcode
SARcode Confidential 29
Slide 85: SARcode
SARcode Confidential 30
Slide 86: SARcode
SARcode Confidential 31
Slide 87: Post Infectious Keratitis Corneal Scarring
SARcode Confidential 33 Post Infectious Keratitis Corneal Scarring
Slide 88: Slide 88
Slide 89: Tecnis Symfony IOL (AMO)
Tecnis Symfony IOL (AMO)
Slide 90: ReStor Multifocal Intraocular Lens (Alcon)
ReStor Multifocal Intraocular Lens (Alcon)
Slide 91: Crystalens Accomodating Intraocular Lens (Bausch & Lomb)
Crystalens Accomodating Intraocular Lens (Bausch & Lomb)
Slide 92: Dry Eye? Cataracts?
DRY EYFS? CATARACTS? VIRGINACYS pad pen’
Slide 93: Multiple Risk Factors
SARcode Confidential 38 Older Age Androgen Deficit: Female Sex, Prostate Cancer Rx Auto-Immune Disease: Sjogrens, RA, SLE Ocular Co-morbidity: Lids, MGD, Allergy, Surgery Cutaneous Disease: Rosacea, Eczema Poor Diet: Low Omega-3, High Fat Medications: Topical, Systemic Neurologic: Senescent Blink, N
Slide 94: HydroEye OSDI Results
SARcode Confidential 63 † p=0.004 n = 19/group 34 21 * p<0.05 † p=0.004 HydroEye® OSDI Results
Slide 95: HLA-DR (green) and CD11c (red)
64 SARcode Confidential 64 HLA-DR (green) and CD11c (red)
Slide 96: HLA-DR Impression Cytology Results
* p<0.001 SARcode Confidential Overall power of the study = 85%65 HLA-DR Impression Cytology Results
Slide 97: SARcode
SARcode Confidential 66
Slide 98: Focus on Dry Eye Prevalence
SARcode Confidential 69 Cataract Surgery Penetrating Keratoplasty Lasik Glaucoma Surgery Blepharoplasty 77% 60% 27% 8% 26% Trattler, ASCRS CME Supplement, 2013 Sheppard, WCC, 2015 Azuma, BMC Research Notes, 2014 Leung, Journal of Glaucoma, 2008 Prischmann, JAMA Facial Plastic Surgery, 2013 Focus on
Slide 99: Dry Eye Severity Levels and Treatment Options
Severity Level 1 2 3 4 Symptoms Mild to moderate Moderate to severe Severe Extremely severe Conjunctival Signs Mild to moderate Staining Staining Scarring Corneal Staining Mild punctate staining Marked punctate staining; central staining; filamentary keratitis Severe staining; corneal erosions Other
Slide 100: SARcode
75 SARcode Confidential 75
Slide 101: SARcode
SARcode Confidential 76
Slide 102: Calcific Band Keratopathy
SARcode Confidential 77 Calcific Band Keratopathy
Slide 103: No Magic Bullet: Dry Eye is a Highly Heterogeneous Disease
SARcode Confidential 135 No Magic Bullet: Dry Eye is a Highly Heterogeneous Disease
Slide 104: Slide 104
Slide 105: Blepharitis Dry Eye Allergy
SARcode Confidential 39 Blepharitis Dry Eye Allergy
Slide 106: Allergic Conjunctivitis
Allergic Conjunctivitis
Slide 107: Custom Allergens Specific to Your Area
CUSTOM ALLERGENS SPECIFIC TO YOUR AREA
Slide 108: Custom Allergens Specific to Your Area
SARcode Confidential 59 CUSTOM ALLERGENS SPECIFIC TO YOUR AREA
Slide 109: Custom Allergens Specific to Your Home
CUSTOM ALLERGENS SPECIFIC TO YOUR HOME
Slide 110: Rationale: Ocular Allergies affect about 20% of Americans
SARcode Confidential 136 Rationale Ocular Allergies affect about 20% of Americans.
Slide 111: Rationale: 50% have concomitant Dry Eye Syndrome
SARcode Confidential 137 Rationale 50% have concomitant Dry Eye Syndrome
Slide 112: Rationale: Americans have both eye disorders
SARcode Confidential 138 Rationale Over 30 million Americans have both eye disorders.
Slide 113: Allergic Conjunctivitis and Dry Eye Syndrome
SARcode Confidential 139 Annals of Allergy, Asthma & Immunology March 2012; 108(3); 163-6. Milton Hom OD, Andrew Nguyen PhD, Leonard Bielory MD Most patients with “itchy eyes” consistent with AC also have dry eyes and redness. These results suggest that some symptomatic patients concomitantly have f
Slide 114: Ocular Allergy Treatments
SARcode Confidential 5 Ocular Allergy Treatments
Slide 115: Current Treatment Modalities
SARcode Confidential 140 Neutriceuticals Allergy nutraceutical helps patients without the deleterious effects associated with Antihistamines. This success led to the development of the eye drop formula. Topical Antihistamines The current treatment of choice for ocular allergies is topical antihistam
Slide 116: Ocular Allergy Complications
SARcode Confidential 141 Ocular Allergy Complications Chronic Discomfort Foreign Body Sensation Pruritis & Epiphora (Itching & Tearing) Decreased Productivity Depression Contact Lens Intolerance Poor Surgical Predictability & Outcomes Inflammatory Keratitis
Slide 117: Slide 117
Slide 118: Allergy Intersects with Dry Eye
SARcode Confidential 141 Allergy Intersects with Dry Eye Dry Eye Treatments (Restasis, Xiidra) are Ineffective for Ocular Allergy ADX-102 is Uniquely Positioned as a Unique MOA for safe long-term treatment of this growing patient cohort ADX-102 shows clinically relevant effects in the Phase IIb Alle
Slide 119: ADX-103 and a New Program in Retinal Disease
ADX-103 and a New Program in Retinal Disease Susan Macdonald, PhD Vice President, Research and Development Aldeyra Therapeutics
Slide 120: A Novel Aldehyde Trap and a New Development Program in Retinal Disease
A Novel Aldehyde Trap and a New Development Program in Retinal Disease ADX-103 Second-in-class aldehyde trap Shown to have mechanism of action as ADX-102, but different structure ADX-103 for retinal disease Like ADX-102, ADX-103 has shown activity in multiple pre-clinical models of ocular disease En
Slide 121: Uveitis: Aldehyde Traps Reduce Retinal Inflammation
Model: Ocular inflammation in rats induced by footpad injection of a bacterial endotoxin (LPS) Disease-related aldehydes: Malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE) Dosing: Single intravitreal dose; 25 µg/eye, one hour following LPS challenge Results: ADX-102 and ADX-103 reduced retinal infl
Slide 122: Macular Degeneration: Aldehyde Traps Reduce Formation of Toxic Retinal Metabolite A2E
Model: Knockout mice that do not express ABCA4, which transports toxic all-trans-retinal metabolite (A2E) to a location in the retina where it is converted to a non-toxic substance Disease-relevant aldehyde: Retinaldehdye Dosing: 10 mg/kg, intraperitoneally, once daily for 56 days Results: Both ADX-
Slide 123: Diabetic Macular Edema: ADX-103 Blocks Diabetic Retinal Degeneration
Model: Streptozotocin (STZ)-induced diabetes in rats. Retinal changes are monitored over time. Disease-relevant aldehydes: Glyoxal and methylglyoxal Dosing: Two single doses of ADX-103, intravitreally, over 29 days, after induction of diabetes Results: Histopathology of the retina 29 days after the
Slide 124: Clinical Trials Successes and Expected 2018 Clinical Milestones
Clinical Trials Successes and Expected 2018 Clinical Milestones David Clark, MD Chief Medical Officer Aldeyra Therapeutics
Slide 125: Five Positive Phase 2 Trials Completed
Five Positive Phase 2 Trials Completed Over 18 Months Allergic Conjunctivitis Phase 2a Uveitis Phase 2 SLS Phase 2 Allergic Conjunctivitis Phase 2b Dry Eye Syndrome Phase 2a
Slide 126: Meta-analysis of ADX-102 Strongly Supports Drug Activity
Meta-analysis of ADX-102 Strongly Supports Drug Activity p value is subject to change based on quality control analysis; between-group comparisons used where placebo control, otherwise within-group comparisons used; dry eye results based on ocular discomfort symptom score.
Slide 127: Expected 2018 Clinical Trial Milestones
Expected 2018 Clinical Trial Milestones* *Pending regulatory agency discussions, additional non-clinical data, and other factors, which may not be in Aldeyra’s control †Timing contingent on product candidate selection and additional non-clinical data Product Candidate Phase Noninfectious Anterior Uv