Clearside posts positive top line Phase 2 data for CLS-TA with Eylea in DME
Clearside Biomedical (NASDAQ:CLSD) reported positive top line results from its Phase 2 TYBEE clinical trial, evaluating suprachoroidal CLS-TA used with intravitreally administered Eylea in patients with diabetic macular edema (DME) over a six-month evaluation period.
Patients treated with CLS-TA achieved comparable vision improvement with fewer treatments.
TYBEE enrolled 71 patients who were naïve to treatment for their DME. Patients were randomized 1:1 to receive either quarterly treatments of suprachoroidal CLS-TA together with Eylea (months 0 and 3) or four monthly treatments of Eylea plus a sham suprachoroidal procedure (months 0, 1, 2 and 3), with patients in either arm receiving intravitreal Eylea treatment at months 3 and 5, as needed.
The trial met its primary endpoint of mean change in best corrected visual acuity from baseline at week 24 (the data were tested for equivalence by comparing the 90% confidence intervals). Patients in the combination arm gained an average of 12.3 ETDRS letters, compared with 13.5 ETDRS letters in the Eylea alone control arm.
“We are pleased with the top line results of this Phase 2 trial, which signals the potential utility of suprachoroidal CLS-TA to improve on the existing standard of care in DME, another sight-threatening disease like RVO and uveitis,” Daniel White, CEO, said in a statement.
“Based on the TYBEE data, we believe suprachoroidal CLS-TA, when given together with an anti-VEGF agent, has potential to provide a more lasting response to treatment, thereby substantially lowering the treatment frequency and burden for DME patients,” he added.
Administration of suprachoroidal CLS-TA with Eylea also met a key secondary endpoint, with a mean reduction from baseline of 208 microns in central subfield thickness (CST) of the retina at six months, compared with a 177-micron mean reduction in the control arm. In addition, 93% of patients in the combination arm had a greater than 50% reduction in excess CST at six months, compared with 73% of patients in the control arm.
“These data add to the growing body of evidence that the combination approach with suprachoroidal CLS-TA has potential to provide a clinically meaningful improvement in vision with fewer treatments in DME,” said Glenn Noronha, CSO.
Based on the initial results from the trial, “we will begin evaluating a Phase 3 program to continue investigating the potential for Clearside’s proprietary treatment approach in patients with diabetic eye disease,” he added.