FDA issues Complete Response Letter for Aldeyra's ADX-2191 NDA for PVRL

Aldeyra Therapeutics, Inc.

FDA cited lack of substantial evidence due to no adequate well-controlled studies in literature-based NDA.
No safety or manufacturing issues identified in the Complete Response Letter.
Aldeyra plans Expanded Access Program discussions with FDA due to methotrexate shortage and no approved PVRL therapy.
ADX-2191 also under development for proliferative vitreoretinopathy and retinitis pigmentosa.
Top-line Phase 2 results in retinitis pigmentosa expected to be announced June 2023.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.