Summary of Aldeyra Therapeutics Conference Call Company Overview - **Company**: Aldeyra Therapeutics (NasdaqCM:ALDX) - **Industry**: Biopharmaceuticals, specifically focusing on immunology and ocular diseases Key Points and Arguments 1. **Lead Asset and Upcoming Milestones**: Aldeyra is preparing for an FDA decision on its lead asset reproxalap for dry eye disease, with a PDUFA date set for December 16, 2025 [4][18][24] 2. **Resubmission of NDA**: The company resubmitted its New Drug Application (NDA) in June 2025 after addressing a Complete Response Letter (CRL) from the FDA, which required an additional trial due to a baseline imbalance [8][9][10] 3. **Clinical Trials and Data**: The recent NDA package included data from a symptom trial that showed no baseline imbalance, which is crucial for FDA approval. The trials assess both symptoms and signs of dry eye disease [12][14][16] 4. **Commercialization Strategy**: Aldeyra has an option agreement with AbbVie, which includes a $100 million opt-in fee after approval, and a revenue-sharing model of 60% to AbbVie and 40% to Aldeyra [20][21][23] 5. **Market Opportunity**: There are approximately 40 million people in the U.S. suffering from dry eye disease, with only 5%-10% currently treated. The market is expected to grow due to increased awareness and more available therapies [24][25] 6. **Allergic Conjunctivitis Program**: Reproxalap is also being developed for allergic conjunctivitis, which is a significant market opportunity. The company has conducted phase three trials showing improvements in redness and itching [25][27] 7. **RASP Pipeline**: Aldeyra is prioritizing next-generation RASP modulators ADX-248 and ADX-246, which are designed to target multiple proteins and have better pharmacokinetics compared to reproxalap [30][31] 8. **Preclinical Data**: The company is exploring the use of RASP modulators in neurological diseases such as Parkinson's and ALS, indicating a potential expansion into central nervous system disorders [34][35] 9. **Ocular Lymphoma and Retinitis Pigmentosa**: Aldeyra is working on a pivotal trial for ocular lymphoma using a new formulation of methotrexate and has shown promising results in retinitis pigmentosa, a rare disease with no current broad therapy [38][39][40] 10. **Dry AMD and Geographic Atrophy**: The company aims to assess the impact of its treatments on night vision in patients with dry AMD, focusing on patient-reported outcomes rather than just lesion size [41][42] Additional Important Information - **Regulatory Environment**: The FDA review process is described as quiet, with no significant delays anticipated due to recent government shutdowns [18] - **Commercial Preparation**: AbbVie is actively preparing for the potential launch of reproxalap, leveraging its experience in the dry eye market [23][24] - **Future Directions**: Aldeyra plans to diversify its pipeline across various indications and stages, with a focus on both ocular and neurological diseases [43][44]