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Clearside, FDA agree on path forward for uveitic macular edema treatment

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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.

CLS-TA is administered by injection into the suprachoroidal space. The primary endpoint of the safety and efficacy study will be the proportion of subjects with 15 or more letters of improvement in best corrected visual acuity on ETDRS chart at 24 weeks after injection with CLS-TA or sham, the release said. The company is finalizing plans to initiate this global study.