Exhibit 99.1
Top-Line Results from thePhase 3 INVIGORATE-2 Trial in Allergic Conjunctivitis
DATA RELEASE June 15, 2023 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2023
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, including
statements regarding Aldeyra’s possible or assumed future results of operations, expenses and financing needs, business strategies and plans, statements regarding Aldeyra's future expectations, plans and prospects, including, without
limitation, statements regarding: Aldeyra's belief in the adequacy of the data it has submitted or plans to submit in the NDAs for reproxalap and ADX-2191; the potential timing for FDA review of such NDAs or the potential for FDA acceptance
of such NDAs; the potential for regulatory approval and commencement of commercialization of reproxalap and ADX-2191 and Aldeyra's goals as to timing; the potential profile and benefit of reproxalap in dry eye disease and allergic
conjunctivitis and its other product candidates in the indications for which they are developed; and other statements regarding the goals, opportunity and potential for reproxalap, anticipated clinical or regulatory milestones for ADX-2191,
ADX-246, ADX-248, and ADX-629 including expectations regarding the results of scheduled FDA meetings, clinical trial initiations and completions and submissions to the FDA; and other statements regarding the goals, opportunity and potential
for reproxalap, ADX-2191, ADX-246, ADX-248, ADX-629 and Aldeyra’s other product candidates, and for Aldeyra's business, research, development and regulatory plans or expectations, political, economic, legal, social and health risks, including
the COVID-19 pandemic and related public health measures and other responses to it, that may affect Aldeyra’s business or the global economy, the structure, timing and success of Aldeyra’s planned or pending clinical trials, expected
milestones, market sizing, pricing and reimbursement, competitive position, regulatory matters, industry environment and potential growth opportunities, among other things. The results of earlier preclinical or clinical trials may not be
predictive of future results. Forward-looking statements include all statements that are not historical facts and, in some cases, can be identified by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” "could," “can,”
“would,” “expect,” “believe,” “anticipate,” “project,” “on track,” “scheduled,” “target,” “design,” “estimate,” “predict,” “contemplates,” “likely,” “potential,” “continue,” “ongoing,” “aim,” “plan,” or the negative of these terms, and
similar expressions intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aldeyra’s actual results, performance or achievements to be
materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect Aldeyra’s current views with respect to future events and are based on assumptions and
subject to risks and uncertainties, including the development of, and clinical and regulatory plans or expectations for Aldeyra’s investigational new drugs (including reproxalap and ADX-2191), and systems-based approaches, later developments
with the FDA that may be inconsistent with Aldeyra’s expectations and beliefs, including the risk that the results from earlier clinical trials, portions of clinical trials, or pooled clinical data may not accurately predict results of
subsequent trials or the remainder of a clinical trial for the same or different indications, inconsistent expectations regarding FDA acceptance and review of the company’s filings and submitted data sets, and Aldeyra’s continuing or post-hoc
review and quality control analysis of clinical data. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements are described in Aldeyra’s most recent Annual Report on
Form 10-K and Quarterly Report on Form 10-Q, as well as Aldeyra’s subsequent filings with the Securities and Exchange Commission. All of Aldeyra's development plans and timelines may be subject to adjustment depending on funding, recruitment
rate, regulatory review, which regulatory review timeline may be flexible and subject to change based on the regulator's workload and other potential review issues, preclinical and clinical results, and other factors any of which could result
in changes to Aldeyra’s development plans and programs or delay the initiation, enrolment, completion, or reporting of clinical trials. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or
unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information in this presentation is provided only as of June 15,
2023, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
The Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis Achieved
All Primary and Secondary Endpoints Statistical significance was achieved for: The primary endpoint of reduction in ocular itching at all prespecified timepoints (P<0.0001) The key secondary endpoint of reduction in ocular redness
(P=0.004) All secondary endpoints (ocular tearing [P<0.0001] and total ocular severity score [P<0.0001]) †Ann Allergy Asthma Immunol, 108(3): 163-6, 2012. Topical ocular reproxalap is an investigational drug candidate that has been
studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials. The results are consistent with other allergic
conjunctivitis clinical trials of reproxalap: the Phase 3 INVIGORATE Trial, the Phase 3 ALLEVIATE Trial, and a Phase 2 allergen chamber trial. The observed activity of reproxalap in allergic conjunctivitis may also benefit patients with dry
eye disease, approximately half of whom suffer from ocular allergy.†
The Allergen Chamber:A Demanding Real-World Drug Assessment in Allergic
Conjunctivitis Slide source: Cliantha Research The allergen chamber Enables a controlled, environmental allergen exposure that mimics real-world exposure to airborne allergens Allows for detailed assessment of prophylaxis and treatment
with unparalleled standardization To our knowledge, no other late-stage investigational allergic conjunctivitis drug has been rigorously tested in an allergen chamber. Patients are exposed to moderate to high levels of ragweed pollen
continuously for approximately 3.5 hrs Drug or vehicle is administered prior to allergen exposure and at 90 minutes, when peak symptoms typically occur Patient-reported ocular itching and tearing scores, and investigator-assessed ocular
redness scores, are obtained approximately every 10 min 4
The Phase 3 INVIGORATE-2 Allergic Conjunctivitis Trial Design
Design Randomized, two-way crossover, vehicle-controlled, double-masked allergen chamber challenge design with 0.25% topical ocular reproxalap Chamber Exposure & Dosing Schedule 3.5 hours continuous allergen exposure First dose just
before chamber entry Second dose 90 minutes after entry (peak allergy symptoms) Inclusion/Exclusion Criteria History of moderate to severe allergic conjunctivitis to ragweed pollen Itching score of ≥2.5 and redness score ≥2 in baseline
chamber assessment ClinicalTrials.gov Identifier: NCT05234554 Primary Endpoint Statistical significance in patient-reported ocular itching (0-4 scale) at a majority of 11 timepoints between 110 and 210 minutes Key Secondary
Endpoint Change from baseline in investigator-assessed ocular redness (0-4 scale) over the duration of the allergen chamber Secondary Endpoints Patient-reported ocular tearing score (0-3 scale) Total ocular severity score (11-point
composite of itching, redness & tearing)
The INVIGORATE-2 Trial Achieved All Primary and Secondary Endpoints P values
derived from mixed effect model of repeated measures analysis. Topical ocular reproxalap is an investigational drug candidate that has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation
site irritation is the most commonly reported adverse event in clinical trials. Primary Endpoint:ACHIEVED Key Secondary Endpoint: ACHIEVED Both Secondary Endpoints: ACHIEVED NO Observed Safety or Tolerability Concerns Statistically
significant improvement vs. vehicle (P<0.0001) over all 11 prespecified timepoints of patient-reported ocular itching score from 110-210 minutes in the allergen chamber Statistically significant improvement vs. vehicle (P=0.004) on key
secondary endpoint of investigator-assessed ocular redness over the duration of the allergen chamber Statistically significant improvement vs. vehicle on secondary endpoints of patient-reported ocular tearing and total ocular severity score
achieved (P<0.0001 for both endpoints) over the duration of the allergen chamber 131 subjects enrolled, 130 of whom completed both treatments; no discontinuations due to adverse events
Reproxalap Achieved Primary Endpoint of Reduction inOcular Itching in the
INVIGORATE-2 Trial Primary endpoint of statistical significance for majority of timepoints achieved over prespecified time frame of 110-210 minutes after allergen chamber entry in change from baseline in patient-reported ocular itching All
timepoints within 110-210 minutes statistically significant in favor of reproxalap (P<0.0001 for each timepoint) Prophylactic and treatment effects of reproxalap demonstrated P values derived from mixed effect model of repeated
measures analysis. Topical ocular reproxalap is an investigational drug candidate that has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly
reported adverse event in clinical trials. KEY RESULTS
Reproxalap Achieved Key Secondary Endpoint of Reduction in Ocular Redness in the
INVIGORATE-2 Trial Key secondary endpoint of statistical significance in change from baseline in investigator-assessed ocular redness over the entire chamber achieved (P=0.004) Prophylactic and treatment effects of reproxalap
demonstrated KEY RESULTS P values derived from mixed effect model of repeated measures analysis. Topical ocular reproxalap is an investigational drug candidate that has been studied in more than 2,400 patients with no observed safety
concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.
Reproxalap Achieved Secondary Endpoint of Reduction inOcular Tearing in the
INVIGORATE-2 Trial Secondary endpoint of statistical significance in change from baseline in patient-reported ocular tearing score over the entire allergen chamber achieved (P<0.0001) Prophylactic and treatment effects of reproxalap
demonstrated KEY RESULTS P values derived from mixed effect model of repeated measures analysis. Topical ocular reproxalap is an investigational drug candidate that has been studied in more than 2,400 patients with no observed safety
concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.
Reproxalap Achieved Secondary Endpoint of Reduction inTotal Ocular Severity
Score in the INVIGORATE-2 Trial Secondary endpoint of statistical significance in total ocular severity score, a composite of patient-reported ocular itching and tearing scores and investigator-assessed ocular redness score over the entire
allergen chamber, achieved (P<0.0001) Prophylactic and treatment effects of reproxalap demonstrated KEY RESULTS P values derived from mixed effect model of repeated measures analysis. Topical ocular reproxalap is an investigational
drug candidate that has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.
Reproxalap Was Generally Well Tolerated and No Safety Concerns Were Observed in
the INVIGORATE-2 Trial No observed safety or tolerability concerns No discontinuations due to adverse events Consistent with other topically administered drugs, most common treatment-emergent adverse events related to transient
instillation site irritation No observed clinically significant findings on safety assessments, including: visual acuity intraocular pressure slit lamp biomicroscopy dilated fundoscopy TOPICAL OCULAR REPROXALAP administered to more
than Topical ocular reproxalap is an investigational drug candidate that has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported
adverse event in clinical trials. 2,400 patients 21 clinical trials across
Reproxalap Demonstrated Consistent Improvement in Ocular Itching Symptoms Across
Late-Stage Allergic Conjunctivitis Clinical Trials Consistent statistically significant symptomatic activity of reproxalap over vehicle in patients with allergic conjunctivitis demonstrated across Phase 2 and Phase 3 allergen chamber
trials Large effect sizes suggest clinically meaningful difference between reproxalap and vehicle in reduction of patient-reported ocular itching KEY RESULTS Topical ocular reproxalap is an investigational drug that has been studied in
over 2,400 patients with no safety concerns reported; mild instillation site discomfort is the most commonly reported adverse event in clinical trials. Effect size is change from baseline divided by baseline standard deviation. CI =
confidence interval.
Reproxalap Demonstrated Consistent Reduction of Ocular Redness Across Two
Distinct Crossover Chamber Challenge Models of Ocular Surface Disease Consistent statistically significant activity of reproxalap over vehicle in reduction of ocular redness demonstrated across Phase 2 and Phase 3 chamber trials in allergic
conjunctivitis and dry eye disease Overall effect size exceeds clinically relevant threshold of 0.5 for ocular redness between reproxalap and vehicle KEY RESULTS Topical ocular reproxalap is an investigational drug that has been studied
in over 2,400 patients with no safety concerns reported; mild instillation site discomfort is the most commonly reported adverse event in clinical trials. Effect size is change from baseline divided by baseline standard deviation. CI =
confidence interval.
Allergic Conjunctivitis and Dry Eye Disease Are Interrelated Inflammatory Ocular
Surface Diseases Slide sources: *Concepts adapted from “The Whipsaw of Allergic Dry Eye” by Mark B. Abelson, MD and Lauren Lilyestrom in REVIEW of Ophthalmology; October 2008; and Ann Allergy Asthma Immunol, 108(3): 163-6,
2012. POLLUTANTS “The clear interaction of allergy, dry eye and environmental irritants makes untangling their etiology in prevalence studies difficult.”* Dry Eye Disease Allergic Conjunctivitis Allergic response can compromise tear
film Dry eye inflammation can enhance allergic response Dry, polluted environments exacerbate both conditions POLLENS Allergens Irritating Air PARCHED ENVIRONMENTS
Aldeyra Has Submitted What is Believed to be the Most Comprehensive Dry Eye
Disease NDA, which Includes Symptoms and Multiple Signs† †The NDA submission includes a combination of primary, secondary, multiplicity-adjusted, and nominal P-value endpoints. ‡Adequate and well-controlled Phase 2 or Phase 3 clinical trials
can be submitted as pivotal. NDA = New Drug Application, SEM = standard error of the mean. Topical ocular reproxalap is an investigational drug candidate that has been studied in more than 2,300 patients with no observed safety concerns; mild
and transient instillation site irritation is the most commonly reported adverse event in clinical trials. Phase 2 Dry Eye Chamber Trial ‡ Phase 3 RENEW–Part 1 Formulation Phase 2‡ P=0.03 Schirmer Test Phase 3 TRANQUILITY-2
Trial Ocular Redness Ocular Dryness Symptom Score ≥10 mm Schirmer Test Responder Analysis P=0.0001 Phase 3 TRANQUILITY-2 Trial P=0.0004 Dryness Symptom Score Change from Baseline ± SEM Dryness Symptom Score Change from Baseline ±
SEM Crossover Trial Crossover Trial Change from Baseline Change from Baseline Odds ratio 2.625 P value versus vehicle <0.0001 Raw Score Change from Baseline Odds ratio 1.551 P value versus
vehicle 0.0361 P=0.016 P=0.0005 P=0.0004
†Regulatory review timelines are flexible and subject to change based on the
regulator's workload and other potential review issues. ‡The timing of ongoing clinical trials depends, in part, on the availability of clinical research facilities and staffing, and the ability to recruit patients. *Investigator
sponsored. Primary Vitreoretinal LymphomaPDUFA date of June 21, 2023† Proliferative VitreoretinopathyType C meeting with FDA to discuss completion of clinical development planned for H2 2023 Retinitis PigmentosaPhase 2 clinical trial
top-line results expected in Q2 2023‡ Dry Eye Disease PDUFA date of November 23, 2023† Atopic Dermatitis (Part 1), Chronic Cough, Idiopathic Nephrotic Syndrome (Part 1), and Sjögren-Larsson Syndrome*Phase 2 clinical trial top-line
results expected in 2023‡ Moderate Alcohol-Associated HepatitisInitiation of Phase 2 clinical trial expected in H2 2023‡ Upcoming Planned Clinical Milestones ADX-2191 Reproxalap ADX-629