The FDA accepts Aldeyra Therapeutics' potential "first-in-class" dry eye disease therapy marketing application
Aldeyra Therapeutics announced today (November 19) that the U.S. FDA has accepted its resubmission of the New Drug Application (NDA) for the innovative ophthalmic drug reproxalap for the treatment of dry eye disease, with a PDUFA date of April 2, 2025. At the same time, Aldeyra also announced the expansion of its exclusive option agreement with AbbVie. Reproxalap is a potential "first-in-class" investigational small molecule aldehyde inhibitor. The levels of reactive aldehydes increase during ocular or systemic inflammation, leading to eye inflammation, reduced tear secretion, redness of the eyes, and changes in the lipid composition of tears, with many dry eye patients exhibiting elevated levels of reactive aldehydes
According to Zhitong Finance APP, Aldeyra Therapeutics (ALDX.US) announced today (November 19) that the U.S. FDA has accepted its resubmission of the New Drug Application (NDA) for the innovative eye drug reproxalap for the treatment of dry eye disease, with a PDUFA date of April 2, 2025. At the same time, Aldeyra also announced the expansion of its exclusive option agreement with AbbVie.
Reproxalap is a potential "first-in-class" investigational small molecule aldehyde inhibitor. The levels of active aldehydes increase during ocular or systemic inflammation, leading to eye inflammation, reduced tear secretion, redness of the eyes, and changes in the lipid composition of tears, with many dry eye patients exhibiting elevated levels of active aldehydes