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FDA接受Aldeyra Therapeutics(ALDX.US)潜在“first-in-class”干眼症疗法上市申请

The FDA has accepted aldeyra therapeutics' (ALDX.US) application for market approval of a potential "first-in-class" therapy for dry eye disease.

Zhitong Finance ·  Nov 19 07:33

Aldeyra therapeutics (ALDX.US) announced that the USA FDA has accepted its resubmission for the new drug application (NDA) of the innovative ophthalmic drug reproxalap for the treatment of dry eye syndrome.

According to Zhitong Finance APP, Aldeyra therapeutics (ALDX.US) announced today (November 19) that the USA FDA has accepted its resubmission for the new drug application (NDA) of the innovative ophthalmic drug reproxalap for the treatment of dry eye syndrome, with a PDUFA date of April 2, 2025. Meanwhile, Aldeyra also announced the expansion of its exclusive option agreement with AbbVie.

Reproxalap is a potential "first-in-class" investigational small molecule reactive aldehyde species inhibitor. The levels of reactive aldehyde species increase during inflammatory conditions in the eye or systemically, causing eye inflammation, decreased tear production, redness of the eyes, and changes in the lipid composition of tears, and many dry eye patients have elevated levels of reactive aldehyde species.

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