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Clearside Expects US FDA to Reject Xipere NDA Until Stability Data Updated
Author: Joan McKenna
Clearside Biomedical reported Aug. 22 that it expects a complete response letter from the US FDA rejecting its new drug application (NDA) for Xipere due to concerns over a manufacturing change.
The Alpharetta, Georgia, company said it implemented an enhanced manufacturing process after data collection was completed for Xipere’s NDA submission.
Xipere (formerly CLS-TA) is a proprietary suspension of the corticosteroid triamcinolone acetonide intended for the treatment of macular edema associated with uveitis. It has an FDA target action date of Oct. 19, 2019.
Clearside said FDA officials have requested stability data using the new process to compare with that of the batches submitted in the NDA.
The company said it plans to provide the requested data when it resubmits its NDA in Q1-2020.