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Clearside submits NDA for uveitic macular edema treatment

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Clearside Biomedical has submitted a new drug application to the FDA for Xipere, its treatment for macular edema associated with uveitis, according to a press release.

Xipere, a proprietary suspension of triamcinolone acetonide, is designed to be administered to the back of the eye through a suprachoroidal injection.

Earlier this year the company released results of the phase 3 PEACHTREE trial, in which 47% of patients dosed with Xipere, formerly known as CLS-TA, gained at least 15 letters in best corrected visual acuity.

“Based on the data from PEACHTREE, our pivotal phase 3 clinical trial, we believe that Xipere has the potential to become a new paradigm in the treatment of uveitic macular edema,” Clearside President and CEO Daniel White said in the release.

If approved, the drug would be the first FDA-approved therapy for macular edema associated with uveitis.