Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (June 2019)
10 slides from Aldeyra Therapeutics's technical presentation, Jun 25, 2019
Slide 1: The SOLACE Trial in Noninfectious Anterior Uveitis Top-Line Results
The SOLACE Trial in Noninfectious Anterior Uveitis Top-Line Results Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019 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: Top-Line SOLACE Trial Results Summary
No statistically significant difference was observed between the reproxalap group and the vehicle control group on the primary (time to cure) or secondary endpoints, due to high rates of disease resolution in vehicle-treated patients. For the primary and all time-to-event secondary endpoints, reprox
Slide 4: The SOLACE Trial Design
The SOLACE Trial Design Primary objective Evaluate efficacy of reproxalap ophthalmic solution (0.5%) on anterior chamber cell count (ACC) vs. vehicle Inclusion highlights Acute endogenous noninfectious anterior uveitis with onset of symptoms within the previous 2 weeks 6-50 ACC in the study eye Intr
Slide 5: Primary and Secondary Time to Event Endpoints – Overall Population
Primary and Secondary Time to Event Endpoints – Overall Population Endpoint Reproxalap Vehicle p value Time to Cure (Anterior Cell Grade 0) 15 days 21 days NS Time to Anterior Cell Grade 1-Point Improvement 7 days 8 days NS Time to Flare Grade 0 8 days 15 days NS Time to Flare Grade 1-Point Improvem
Slide 6: Immune-Modulating Activity Observed in SOLACE Consistent with Phase 2 Trial Results
ITT = Intention-To-Treat Source: SOLACE noninfectious anterior uveitis clinical trial results and Phase 2 noninfectious anterior uveitis clinical trial results Immune-Modulating Activity Observed in SOLACE Consistent with Phase 2 Trial Results, Which Were Statistically Noninferior to Corticosteroid
Slide 7: Primary and Secondary Time to Event Endpoints – Moderate Patients (Pre-Specified Subgroup)
Moderate patients defined as patients with anterior chamber cell count grade of 2+. Time to event represents 25th percentile Kaplan Meier estimates. Time to event p values represent log-rank tests. The combined p value is the fixed effect meta-analysis of log hazard ratios. Source: SOLACE noninfecti
Slide 8: Reproxalap Statistically Superior to Vehicle in Patients with Moderate Severity
Immune-Modulating Activity of Reproxalap was Statistically Superior to that of Vehicle in Patients with Moderate Severity (a Pre-Specified Subgroup) Proportion Cured (Grade 0 = no inflammatory cells observed) Week 4 Grade 0 Percent of Subjects Reproxalap 53% Vehicle 25% Mean Change from Baseline Day
Slide 9: Topical Ocular Reproxalap Was Generally Well Tolerated and No Safety Concerns Were Observed
Now administered to over 800 patients across nine completed clinical trials No observed safety or tolerability concerns, consistent with previous clinical trials Topical Ocular Reproxalap Was Generally Well Tolerated and No Safety Concerns Were Observed in SOLACE Source: SOLACE noninfectious anterio
Slide 10: Aldeyra intends to prioritize high-value Phase 3 ocular programs
Aldeyra intends to prioritize high-value Phase 3 ocular programs Ocular Program Status Allergic Conjunctivitis Positive ALLEVIATE Phase 3 clinical trial results, announced March 2019 Positive allergen chamber clinical trial results, announced June 2019 Subsequent Phase 3 trial expected to be confirm
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