Aldeyra Therapeutics(US:ALDX)2025-12-16 14:02Summary of Aldeyra Therapeutics Regulatory Update Conference Call Company Overview - Company: Aldeyra Therapeutics (NasdaqCM:ALDX) - Focus: Development of reproxalap for the treatment of dry eye disease Key Points Regulatory Update - PDUFA Extension: The FDA has extended the PDUFA target action date for the new drug application (NDA) of reproxalap, originally set for December 16, 2025, due to the request for additional clinical study reports (CSR) [2][8][10] - NDA Resubmission: The NDA for reproxalap was resubmitted on June 16, 2025, and accepted by the FDA as a complete Class II response on July 16, 2025 [6] - Field Trial Results: A field trial supportive of reproxalap did not meet its primary endpoint of reducing symptoms compared to the vehicle, which led to the FDA's request for the CSR to be included in the NDA [7][9] FDA Interactions - Communication with FDA: Aldeyra has had limited direct communication with the FDA's Office of Specialty Medicine, focusing primarily on the Division of Ophthalmology [5] - Labeling Discussions: A draft label was sent by the FDA to Aldeyra in early December, and Aldeyra has provided comments on it [9][32] - Next Steps: If no major deficiencies are identified during the extended review, labeling requests and potential post-marketing requirements will be communicated by February 16, 2026 [10] Commercialization and Agreements - AbbVie Option Agreement: AbbVie has 10 business days to exercise its option following the approval of the NDA, with no changes to the terms due to the extension [18][27] - Commercialization Timeline: The launch date for reproxalap will depend on FDA approval, with expectations that it could occur within one to two quarters post-approval [21] Additional Insights - FDA Guidance: There was a discussion regarding the standard practice of submitting all CSRs with an NDA, which was initially agreed upon to be limited to the chamber trial only [14][15] - Safety Data Requests: The request for safety data from the field trial is considered standard during NDA reviews [25] - Director Changes: The director of the Office of Specialty Medicine retired, which may have influenced the recent request for the CSR submission [13] Conclusion The call provided detailed insights into the regulatory status of reproxalap, the implications of the FDA's extension of the PDUFA date, and the company's ongoing interactions with the FDA. The potential for commercialization remains contingent on the outcome of the extended review process.