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Aldeyra Therapeutics (ALDX) 2025 Conference Transcript

Summary of Aldeyra Therapeutics Conference Call Company Overview - Aldeyra Therapeutics is an immunology company focused on developing treatments for eye diseases, particularly dry eye disease and allergic conjunctivitis [6][7][8] Core Product: Reproxalap - Reproxalap is in development for dry eye disease and allergic conjunctivitis, targeting conditions that currently lack effective acute treatments [7][8] - The company is preparing to resubmit a New Drug Application (NDA) to the FDA for reproxalap after receiving a complete response letter in April 2023, which requested an additional trial [8][19][20] - The FDA's approval process for dry eye disease requires both symptom and sign assessments, focusing on redness and discomfort [11][12][18] Regulatory Developments - The first NDA submission was in 2022, but the FDA requested another trial due to a failed co-primary endpoint [20][22] - A successful chamber trial has been completed, which is expected to support the resubmission of the NDA [21][23] - The company is awaiting feedback from the FDA regarding the recent trial data and plans to resubmit the NDA soon [24][25][29] Market Opportunity - Approximately 40 million people in the U.S. suffer from dry eye disease, with a significant portion untreated due to the ineffectiveness of current therapies [43][44] - The unmet need is particularly pronounced for about 5 million patients who do not respond to artificial tears [44][46] - Reproxalap aims to differentiate itself by providing rapid relief, with the potential for symptom improvement in minutes rather than weeks [17][42] Allergic Conjunctivitis - Reproxalap is also being studied for allergic conjunctivitis, a condition affecting a significant portion of the population, with many patients not adequately responding to current treatments [49][50] - The company has conducted two phase three trials in a chamber setting to assess the drug's efficacy in this area [51] Pipeline Developments - Aldeyra is exploring other programs, including retinitis pigmentosa, where methotrexate is being tested as a potential treatment [53][56] - The company is also developing ADX-248, an oral RASP inhibitor for atopic dermatitis, currently in phase one clinical testing [59][60] - Updates on the alcoholic hepatitis program are expected, focusing on the role of acetaldehyde in the disease [62][63] Key Milestones - Investors are particularly focused on the timeline for NDA submission, acceptance, and approval, which are anticipated within the year, pending positive discussions with the FDA [64][65]