Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (September 2017)
12 slides from Aldeyra Therapeutics's technical presentation, Sep 12, 2017
Slide 1: Dry Eye Disease Phase 2a Results
Dry Eye Disease Phase 2a Results September 12, 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: Dry Eye Disease Phase 2a Data Highlights
Dry Eye Disease Phase 2a Data Highlights Statistically significant and clinically relevant improvement in multiple dry eye disease signs and symptoms Rapid onset of activity within one week of dosing Improvement increased over time, and a modest dose-response was observed, supporting activity of ADX
Slide 4: 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 5: Statistically Significant Improvement in Multiple 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 6: Tear Aldehyde Reduction Supportive of ADX-102 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.
Slide 7: Symptom Improvement Over Time Supportive of Drug Activity
Symptom Improvement Over Time Supportive of Drug Activity
Slide 8: Improvement Effect Sizes Are Robust and Statistically Significant
Improvement Effect Sizes Are 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.
Slide 9: Dose Selection for Phase 2b Clinical Testing
Dose Selection for Phase 2b Clinical Testing No observed safety concerns Stinging consistent with other eye drops and prior ADX-102 clinical experience, generally resolving within minutes Tolerability of 0.1% ADX-102 consistent with standard of care, and was better than that of 0.5% ADX-102 formulat
Slide 10: 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, fundi
Slide 11: Results Strategic Implications
Dry Eye Disease Results Strategic Implications Aldeyra R&D Day October 10, 2017 A novel mechanism of action with confirmed clinically relevant activity suggests that ADX-102 offers a differentiated approach for treatment of dry dye disease patients, which accounted for approximately $1.8B in 2016 US
Slide 12: Expected 2018 Clinical Trial Milestones
Expected 2018 Clinical Trial Milestones* *Pending regulatory agency discussions, additional non-clinical data, funding, 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 An
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