Clearside Biomedical Inc (NASDAQ: CLSD) rose in Monday trading the company disclosed positive topline results from its pivotal Phase 3 clinical trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis.
The company, based in Alpharetta, Georgia, announced Monday Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS™, which is the space located between the choroid and the outer protective layer of the eye known as the sclera.
Clearside enrolled 160 patients in this randomized, controlled, masked Phase 3 pivotal clinical trial. Of the 160 patients enrolled, 96 patients were randomized to the treatment arm to receive two 4.0 mg doses of suprachoroidal CLS-TA 12 weeks apart, and 64 patients were randomized to undergo sham procedures at the same 12-week interval.
Patients were evaluated every four weeks for a total of 24 weeks, and a total of 155 patients, or 97% of those enrolled, completed the full evaluation period of the trial.
An official connected with the study was quoted thus, "The PEACHTREE study was the first pivotal phase 3 clinical trial of a drug candidate for patients with uveitic macular edema in which a BCVA measure was the primary efficacy endpoint, potentially raising the bar for future trials in this population. Typically, uveitic macular edema may persist despite adequate control of uveitis itself, and it is challenging to treat and may persist despite multiple interventions."
Clearside shares approached noon Monday up $2.90, or 37.1%, to $10.72.