Clearside Biomedical announces resubmission of new drug application for Xipere for treatment of macular oedema associated with uveitis

Clearside Biomedical

3 May 2021 - Clearside Biomedical announced today the resubmission of its new drug application to the U.S. FDA for Xipere (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of macular oedema associated with uveitis.

Clearside’s resubmission is a full and complete response to all of the items identified in the complete response letter received from the FDA on October 18, 2019. 

Clearside believes this application will be considered a Class 2 resubmission, with a targeted six-month review timeline under the Prescription Drug User Fee Act.

Read Clearside Biomedical press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier