Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (December 2019)
16 slides from Aldeyra Therapeutics's technical presentation, Dec 3, 2019
Slide 1: The RENEW Trial in Dry Eye Disease: Part 1 Top-Line Results
The RENEW Trial in Dry Eye Disease: Part 1 Top-Line Results DATA RELEASE December 3, 2019 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2019 Exhibit 99.2
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: In Part 1 of RENEW, Reproxalap Demonstrated Early Onset and Broad Improvements in Symptoms
In Part 1 of RENEW, Reproxalap Demonstrated Early Onset and Broad Improvements in Symptoms The RENEW Trial is an ongoing adaptive, two-part, Phase 3 clinical trial. The primary objective of Part 1 was to confirm dosing regimen, endpoints, and sample size for RENEW-Part 2. The primary objective of RE
Slide 4: Dry Eye Disease is a Persistently Disturbing Condition that is Inadequately Treated
Up to 75% of patients with DED are not satisfied with current Rx options. Up to 75% Dry Eye Disease is a Persistently Disturbing Condition that is Inadequately Treated The dry eye disease patient population is underserved, and novel therapies are in demand. 34 million or more adults in the U.S. suff
Slide 5: The RENEW Trial in Dry Eye Disease
Primary Objective Confirm endpoints Confirm sample size Confirm dosing regimen The RENEW Trial in Dry Eye Disease RENEW-Part 1 Reproxalap 0.25% RENEW-Part 2 Reproxalap 0.25% RENEW: An Ongoing Adaptive Two-Part, Multi-Center, Randomized, Vehicle-Controlled, Double-Masked, Parallel-Group Phase 3 Clini
Slide 6: RENEW-Part 1 Clinical Trial Design
RENEW-Part 1 Clinical Trial Design RENEW-Part 1 primary objective: Evaluate efficacy of reproxalap ophthalmic solution (0.25%) vs. vehicle to confirm dosing regimen, endpoints, and sample size of RENEW-Part 2 RENEW-Part 1 inclusion/exclusion criteria: Moderate to severe dry eye disease RENEW co-prim
Slide 7: Demonstrated Rapid and Durable Improvement in Co-Primary Endpoint of Ocular Dryness Score
Reproxalap Demonstrated Rapid and Durable Improvement in Co-Primary Endpoint of Ocular Dryness Score in RENEW-Part 1 Ocular Dryness Score (VAS)† Baseline and Weeks 1 to 12 Ocular Dryness Score (VAS)† Change From Baseline Weeks 1 to 12 Co-Primary Symptom Endpoint for RENEW ** MMRM p = 0.0004 **p<0.01
Slide 8: Demonstrated Highly Statistically Significant Reductions in Ocular Dryness
Reproxalap Demonstrated Highly Statistically Significant Reductions in Ocular Dryness in RENEW-Part 1 Ocular Dryness Score (VAS) Treatment Difference (Reproxalap-Vehicle)* †Pending clinical data, regulatory discussions, payor negotiations, competition, potential legislative changes, and other factor
Slide 9: Demonstrated Broad Statistically Significant Symptom Improvement
Reproxalap Demonstrated Broad Statistically Significant Symptom Improvement in RENEW-Part 1 SANDE: Severity VAS: Ocular Dryness (Co-Primary) VAS: Eye Discomfort VAS: Photophobia VAS: Foreign Body Sensation VAS: Itching VAS: Pain VAS: Burning/Stinging OSDI (Total) SANDE: Frequency OD4S: Grittiness OD
Slide 10: Demonstrated Rapid Improvement in Co-Primary Endpoint of Fluorescein Staining Score
Reproxalap Demonstrated Rapid Improvement in Co-Primary Endpoint of Fluorescein Staining Score in RENEW-Part 1 Fluorescein Staining: Nasal Region† (0-4) Baseline and Weeks 1 to 12 Fluorescein Staining: Nasal Region† Change From Baseline Weeks 1 to 4 Co-Primary Sign Endpoint for RENEW MMRM p = 0.0313
Slide 11: Demonstrated Rapid and Broad Staining Improvements
Reproxalap Demonstrated Rapid and Broad Staining Improvements in RENEW-Part 1 Favors Reproxalap Fluorescein Staining Treatment Difference (Reproxalap-Vehicle) Over Weeks 1 to 4* Total Eye Sum Corneal Sum Nasal† Temporal Inferior Conjunctival Sum 0.0393 0.0157 0.0313 0.0223 0.0314 p-value NS 0-4 Ocul
Slide 12: Was Generally Well Tolerated and No Adverse Findings on Safety Assessments Were Observed
Reproxalap Was Generally Well Tolerated and No Adverse Findings on Safety Assessments Were Observed in RENEW-Part 1 No treatment-related serious adverse events were reported. The most common treatment-emergent event was mild transient instillation site irritation. The majority of reported adverse ev
Slide 13: In Part 1 of RENEW, Reproxalap Demonstrated Early Onset and Broad Improvements in Symptoms
In Part 1 of RENEW, Reproxalap Demonstrated Early Onset and Broad Improvements in Symptoms The RENEW Trial is an ongoing adaptive, two-part, Phase 3 clinical trial. The primary objective of Part 1 was to confirm dosing regimen, endpoints, and sample size for RENEW-Part 2. The primary objective of RE
Slide 14: RENEW-Part 2 Clinical Trial Design
RENEW-Part 2 Clinical Trial Design* RENEW-Part 2 primary objective: Evaluate efficacy of reproxalap ophthalmic solution (0.25%) vs. vehicle for the symptoms and signs of dry eye disease RENEW-Part 2 inclusion/exclusion criteria: Same as used for RENEW-Part 1 Moderate to severe dry eye disease RENEW
Slide 15: A New Paradigm for the Treatment of Ocular Diseases
A New Paradigm for the Treatment of Ocular Diseases: A Potential Single Treatment for Dry Eye Disease and Allergic Conjunctivitis* *Contingent on funding, regulatory review, clinical results and other factors Reproxalap 0.25% Rapid and consistent symptom and sign improvements in RENEW-Part 1 top-lin
Slide 16: Upcoming and Recently Achieved Reproxalap Topical Ocular Development Milestones
Positive reproxalap allergic conjunctivitis allergen chamber trial top-line results Positive reproxalap allergic conjunctivitis ALLEVIATE Phase 3 trial results Primary objective met in reproxalap dry eye disease RENEW Phase 3-Part 1 top-line results Upcoming and Recently Achieved Reproxalap Topical
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