FDA Issues Complete Response Letter for Reproxalap in Dry Eye Disease
Aldeyra Therapeutics’ new drug application for reproxalap was not approved due to insufficient clinical trial data demonstrating efficacy.
The FDA issued a complete response letter for reproxalap, citing inconsistencies in the clinical trial results and insufficient evidence of its effectiveness for dry eye disease.
Aldeyra Therapeutics will request a Type A meeting with the agency to discuss potential pathways forward, while no additional trials are currently required.
Alert Type | Complete Response Letter (FDA) |
Drug/Device Name | Reproxalap |
Indication | Dry eye disease |
Therapy Area(s) | Ophthalmology |
Geography | US (FDA) |
What Changed | The FDA issued a complete response letter for Aldeyra Therapeutics’ NDA for reproxalap, citing insufficient evidence of efficacy and inconsistencies in clinical trial results under the proposed conditions of use. |
Clinical Relevance | Reproxalap’s effectiveness remains unproven; further guidance from the FDA will be required before potential market access. |
Source Link | |
Date | 27-Feb-2026 |
Status | Draft |
Notes | FDA recommended exploring reasons for trial failures and identifying responsive populations; no new trials required. Aldeyra plans a Type A meeting within 30 days. Company cash position as of 31-Dec-2025: $70m, supporting operations into 2028. |
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