Aldeyra Therapeutics Reports Full-Year 2021 Financial Results and Recent Corporate Highlights

• Top-Line Data from Proof-of-Concept Clinical Trials of ADX-629 in Multiple Systemic Indications Expected by the End of March 2022
• Results from Phase 3 TRANQUILITY-2 Trial of Reproxalap in Dry Eye Disease Expected Mid-2022
• Results from Part 1 of Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy Expected in the Second Half of 2022
• Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Initiated in the First Quarter of 2022; Results Expected in the Second Half of 2022
• Cash and Cash Equivalents of $229.8 Million as of December 31, 2021; Projected Cash Runway Through 2023
• Management to Host Conference Call at 8:00 a.m. ET Today

LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, today reported recent corporate highlights and financial results for the year ended December 31, 2021.

“In addition to our planned completion of clinical development for reproxalap in dry eye disease, 2022 is expected to highlight data milestones for our systemic and retinal disease platforms,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer. “We are excited about the planned release this month of top-line data from our proof-of-concept clinical trials of ADX-629, a first-in-class RASP modulator, across a variety of systemic inflammatory diseases, and we look forward to reporting results of our recently initiated clinical trial of ADX-2191 in retinitis pigmentosa in the second half of this year.”

Recent Corporate Highlights

• Initiated Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa. Aldeyra initiated a Phase 2 clinical trial of ADX-2191 (intravitreal methotrexate 0.8%), an investigational new drug product, in retinitis pigmentosa, a rare, sight-threatening retinal disease with no approved therapy. The trial is being conducted at Duke University Medical Center.
• Reported Positive Results from Phase 2 Dry Eye Chamber Clinical Trial of Reproxalap Compared to Xiidra®. In a Phase 2 dry eye chamber clinical trial, ocular discomfort and ocular itching symptom scores were assessed following treatment with either reproxalap or Xiidra (lifitegrast ophthalmic solution 5%). Both ocular discomfort (p=0.002) and ocular itching (p=0.01) were statistically lower after treatment with reproxalap than with Xiidra.
• Reported Results from Phase 3 TRANQUILITY Trial of Reproxalap in Dry Eye Disease. Although the primary endpoint of ocular redness was not met in the TRANQUILITY Trial, statistical significance (p=0.0001) was achieved for the dry eye disease sign of Schirmer test, a secondary endpoint. The Schirmer test has been accepted by the U.S. Food and Drug Administration as an approvable objective sign that can be used to support a New Drug Application (NDA) for dry eye disease.
• Continued Enrollment in Phase 3 TRANQUILITY-2 Trial of Reproxalap. Patient enrollment continued in the Phase 3 TRANQUILITY-2 Trial of reproxalap in dry eye disease. The primary endpoint of the trial will be met if either Schirmer test or ocular redness achieves statistical significance in favor of reproxalap over vehicle.
• Completed Enrollment in Part 1 of Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy. Patient enrollment concluded in Part 1 of the Phase 3 GUARD Trial of ADX-2191 in patients with proliferative vitreoretinopathy, a rare, sight-threatening retinal disease with no approved therapy.
• Initiated Enrollment in Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis. Patient enrollment began in the Phase 3 INVIGORATE-2 Trial of reproxalap in allergic conjunctivitis. The protocol of INVIGORATE-2 is substantially identical to that of the Phase 3 INVIGORATE Trial, which, relative to vehicle, demonstrated statistically significant reductions in patient-reported ocular itching (p