Clearside Biomedical (NSDQ:CLSD) said today that the FDA ordered the company to provide stability data on its new manufacturing process for triamcinolone acetonide suspension, pushing the timeline on the agency’s decision into next year.
Alpharetta, Ga.-based Clearside’s Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis.
Clearside said the formulation of the TA suspension is unchanged, but the FDA wants data on its new manufacturing process to compare with data from the original NDA submission. The requested data doesn’t involve or affect its SCS microinjector platform, the company said.
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