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Clearside enrolls first patient in CLS-TA phase 3 clinical trial

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Clearside Biomedical enrolled its first patient for the phase 3 clinical trial of CLS-TA to treat macular edema associated with noninfectious uveitis, according to a company press release.

The phase 3 Peachtree clinical trial to evaluate efficacy of 4 mg CLS-TA (triamcinolone acetonide) delivered via the suprachoroidal space is set to last 6 months. The trial is randomized, masked and sham-controlled with a clinical endpoint at 24 weeks of a 15-letter change in best corrected visual acuity from baseline. The company expects approximately 150 patients to enroll across 50 sites.

“The enrollment of our first patient and the advancement of CLS-TA into a pivotal trial for uveitis is a milestone for our organization and puts Clearside on a potential course to file our [new drug application] in 2017,” Clearside CEO and President Daniel H. White said in the release.

Clearside currently has more than 70 patients in five ongoing clinical efficacy trials using suprachoroidal space drug administration for treatment of retinal vein occlusion, diabetic macular edema and wet age-related macular degeneration.