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Clearside, FDA agree on path forward for uveitic macular edema treatment
Clearside Biomedical and the FDA have agreed on the overall development plan for CLS-TA, triamcinolone acetonide injectable suspension, for treatment of macular edema associated with non-infectious uveitis, according to a company press release. “The Agency has accepted our proposed plan to conduct one randomized, double-masked, sham-controlled phase 3 clinical study along with appropriate literature supporting this indication as part of the requirements for a potential 505(b)(2) NDA submission,” Daniel H. White, president and CEO of Clearside, said in the release.