Clearside Biomedical, Inc. – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Clearside Biomedical, Inc. for its New Drug Application (NDA 211950) for XIPERE (triamcinolone acetonide ophthalmic suspension) for suprachoroidal injection. The agency identified several critical deficiencies that prevent approval. Key issues include non-compliance with current Good Manufacturing Practice (CGMP) regulations (21 CFR 210 and 211) at a manufacturing facility, requiring satisfactory resolution of observations or the provision of compliant alternative facilities. Additionally, insufficient safety information was provided, necessitating clinical use data for the final SCS Microinjector Delivery System, to be evaluated by at least three physicians and 30 patients. The FDA also requires data from three new registration batches using the proposed commercial process, demonstrating robustness, quality, and stability, including three months of long-term and accelerated stability data for at least one batch. Finally, amendments to the application did not comply with 21 CFR 314.60(f) regarding patent certifications or statements; Clearside must provide a detailed list verifying compliance. Clearside must resubmit its application within one year, fully addressing all identified deficiencies to pursue approval.