Slide 1: Top-Line Results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in PVR
Top-Line Results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy October 6, 2022 NASDAQ: ALDX ©Aldeyra Therapeutics, Inc. 2022
Slide 2: Forward-looking statements
2 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’
Slide 3: The Phase 3 GUARD Trial of ADX-2191 in PVR Met the Primary Endpoint
3 The primary endpoint of reduction of retinal detachment over 6 months in ADX-2191-treated patients vs. historical control* was achieved (P=0.024). Numerical superiority of ADX-2191 over routine surgical care was demonstrated for multiple secondary and exploratory endpoints, none of which were stat
Slide 4: ADX-2191, an Investigational Vitreous-Compatible Formulation of Methotrexate, Represents a Platform Approach
ADX-2191, an Investigational Vitreous-Compatible Formulation of Methotrexate, Represents a Platform Approach for Rare Retinal Diseases 4 ADX-2191 (methotrexate injection, USP) is the first sterile, non-compounded formulation of methotrexate designed to meet the unique requirements of intravitreal ad
Slide 5: ADX-2191 Represents a Novel Potential Therapeutic Option For the Prevention of PVR
ADX-2191 Represents a Novel Potential Therapeutic Option For the Prevention of Proliferative Vitreoretinopathy 5 Source: Aldeyra internal estimates. Data on file. PVR = proliferative vitreoretinopathy. ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug
Slide 6: Preclinical and Clinical Results Support the Anti-Proliferative Activity of Methotrexate
Preclinical and Clinical Results Support the Anti-Proliferative Activity of Methotrexate for the Prevention of Proliferative Vitreoretinopathy 6 Sources: ADX-2191 PVR Phase 1b investigator sponsored clinical trial (n=10) results and additional in-practice use (n=16); Invest Ophthalmol Vis. Sci. 2017
Slide 7: Activity of Methotrexate for Prevention of PVR is Supported by Peer-Reviewed Publications
RETINAL CASES & BRIEF REPORTS – JANUARY 2022 AMERICAN SOCIETY OF RETINAL SPECIALISTS 2022 MEETING Management of Proliferative Vitreoretinopathy with Intravitreal Methotrexate using a Treat-and-Extend Protocol Walter S, et al The Activity of Methotrexate for the Prevention of Proliferative Vitreoreti
Slide 8: ADX-2191: Design of Part 1 of the Adaptive Phase 3 GUARD Trial in PVR
ADX-2191: Design of Part 1 of the Adaptive Phase 3 GUARD Trial in Proliferative Vitreoretinopathy 8 Primary ObjectiveEvaluate efficacy of intravitreal ADX-2191 injections for prevention of PVR-associated retinal detachment to estimate statistical power for Part 2 of GUARD DesignMulti-center Phase 3
Slide 9: The Primary Endpoint of Reduction of Retinal Detachment vs. Historical Control Was Achieved
9 ADX-2191 (n=68) Historical Control† (n=292) Patients with retinal detachment within 6 months of surgery 16 113 Odds ratio (95% CI) vs. historical control 0.49 (0.26, 0.89) P value vs. historical control* 0.024 †Ophthalmology 124(6):757-767, 2017; Archives of Ophthalmology 25(9):1161-7, 2007. *Fish
Slide 10: The Majority of Secondary and Exploratory Endpoints Were Numerically in Favor of ADX-2191
10 The Majority of Secondary and Exploratory Endpoints, While Not Statistically Powered, Were Numerically in Favor of ADX-2191 ADX-2191 (n=68) Routine Surgical Care (n=38) Letters of visual acuity (SD) 32.9 (19.7) 36.5 (25.0) Central macular subfield thickness (mM, SD) 382 (182) 484 (233) SD = stand
Slide 11: ADX-2191 Was Well Tolerated and No Safety Concerns Were Observed
11 ADX-2191 Was Well Tolerated and No Safety Concerns Were Observed †Annals of Hematology, 95(4), 593–601, 2016. ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. The most common adverse event associated with ADX-2191 administration was punc
Slide 12: ADX-2191 Was Numerically Favorable to Routine Surgical Care for Additional Key Safety Endpoints
12 ADX-2191 Was Numerically Favorable to Routine Surgical Care for Additional Key Safety Endpoints CI = confidence interval. P value derived from random effect meta-analysis. ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. All treatment-em
Slide 13: Upcoming Planned Clinical Milestones for ADX-2191
Upcoming Planned Clinical Milestones for ADX-2191* 13 *The timing of ongoing clinical trials depends, in part, on the availability of clinical research facilities and staffing, and the ability to recruit patients. Primary Vitreoretinal Lymphoma Pre-NDA meeting scheduled for Q4 2022 Proliferative Vit