Clearside Biomedical (NSDQ:CLSD) touted new analyses of data from the company’s Phase III pivotal trial of suprachoroidal CLS-TA in people with uveitic macular edema.
The company’s investigational treatment is a suspension of triamcinolone acetonide formulated to be delivered to the back of the eye via the suprachoroidal space.
Clearside reported that 40% of people taking its product, Xipere, experienced resolution of uveitis compared to 0% of people in the control arm. The company also noted that 68% of people with a baseline level of vitreous haze, 72% of people with anterior chamber cell inflammation and 74% of people with anterior chamber flare in the Xipere arm saw their inflammation resolve, compared to 23%, 17% and 20% respectively in the control arm.
“The Peachtree trial was the first pivotal Phase III clinical trial to demonstrate improvement in vision for patients with uveitic macular edema, and patients experiencing resolution of uveitis is an important outcome for uveitis specialists and for their patients,” principal investigator Dr. Rahul Khurana said in prepared remarks. “These additional data add to my confidence that Xipere holds promise for my patients with uveitic macular edema.”
Clearside also touted an analysis of the mean change in best-corrected visual acuity from baseline after 24 weeks from each location of uveitis: anterior, intermediate, posterior and panuveitis.
“Unlike current therapies, which have shown efficacy in certain locations of uveitis, such as anterior or posterior segment uveitis, patients treated with Xipere in the Peachtree trial achieved visual improvement across all anatomical locations of uveitis. This serves to further differentiate the impressive clinical profile of Xipere,” Khurana added.
Clearside is slated to submit a new drug application to the FDA for Xipere as a treatment for uveitic macular edema by the end of the year.
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