Clearside Biomedical (NSDQ:CLSD) shares soared more than 50% in pre-market activity today after the company reported that its suprachoroidal eye drug succeeded in a pivotal Phase III trial of patients with macular edema associated with non-infectious uveitis.
The company’s drug, CLS-TA, is a proprietary suspension of a corticosteroid, triamcinolone acetonide, designed to be administered to the back of the eye via the suprachoroidal space.
The 160-patient trial randomized 96 people to receive two 4.0-mg doses of suprachoroidal CLS-TA at 12-week intervals and 64 people to receive sham procedures. Researchers evaluated the study participants every four weeks for a total of 24 weeks.
Clearside touted that 47% of patients who received suprachoroidal CLS-TA gained at least 15 letters in best corrected visual acuity between baseline and week 24, versus just 16% of patients in the control group.
The study also met its secondary endpoint, according to Clearside: patients who received the company’s eye drug had a mean reduction in central subfield thickness of 157 microns after 24 weeks compared to just 19 microns in the control group.
After 24 weeks, 11.5% of patients in the treatment group reported corticosteroid-related elevated intraocular pressure adverse events.
“These positive topline data from Peachtree are very encouraging for this population with macular edema as a complication due to their uveitis,” investigator Dr. Rahul Khurana said in prepared remarks. “The Peachtree study was the first pivotal Phase III 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. Also, while corticosteroids are the most common treatment for all complications of uveitis, including the associated macular edema, systematic controlled studies of this kind are rare.”
“Having nearly 50% of the Peachtree trial patients treated with suprachoroidal CLS-TA gain 15 or more letters in vision is highly compelling. It represents a huge step forward in advancing suprachoroidal administration of CLS-TA towards becoming a powerful new approach in potentially treating blinding eye diseases,” Clearside CEO & president Daniel White added.
“We currently expect to submit a new drug application for suprachoroidal CLS-TA in patients with macular edema associated with uveitis to the FDA in the fourth quarter of 2018, and we are also evaluating a number of options for submissions to regulatory agencies in additional territories outside of the United States,” the chief executive said.
CLSD shares were up 67.5% in premarket activity today, trading at $13.08 apiece.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.