Clearside Biomedical announced positive topline results from its phase 2 clinical trial evaluating suprachoroidal CLS-TA used with intravitreally administered Eylea (aflibercept) in patients with diabetic macular edema (DME) over a 6-month evaluation period, according to a company news release.
TYBEE, a multicenter, randomized, masked, controlled phase 2 trial, enrolled 71 patients who were naïve to treatment for DME. Patients were randomized 1:1 to receive either quarterly treatments of suprachoroidal CLS-TA together with intravitreal Eylea (months 0 and 3) (the combination arm) or four monthly treatments of intravitreal Eylea plus a sham suprachoroidal procedure (months 0, 1, 2 and 3) (the control arm), with patients in either arm receiving intravitreal Eylea treatment at months 4 and 5 as needed.
The trial met its primary endpoint of mean improvement in best corrected visual acuity (BCVA) from baseline over 6 months as measured using the ETDRS scale. Patients in the combination arm gained an average of 12.3 ETDRS letters compared to 13.5 ETDRS letters in the Elyea alone control arm (P = 0.664).
“We are pleased with the topline 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, Clearside’s Chief Executive Officer and President, said in a company news release. “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.”
Additionally, administration of suprachoroidal CLS-TA together with intravitreal Eylea met a key secondary endpoint with a mean reduction from baseline of 208 microns in central subfield thickness (CST) of the retina at 6 months, compared to a 177 micron mean reduction in the control arm (P = 0.156). Further, 93% of patients in the combination arm had a greater than 50% reduction in excess CST at six months, compared to 73% of patients in the control arm.
Suprachoroidal CLS-TA used together with intravitreal Eylea was generally well tolerated, with no treatment-related serious adverse events reported in the TYBEE trial through the 24 week evaluation period. Elevated intraocular pressure adverse events were reported for 8.3% of patients in the combination arm, compared to 2.9% of patients in the control arm. Both the combination and control arms reported cataract adverse events, with approximately 5.6% of patients in the combination arm and 2.9% of patients in the control arm developing cataracts.
Clearside is continuing to analyze data from the TYBEE trial and detailed results will be shared at an upcoming medical meeting.
“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, PhD, Clearside’s Chief Scientific Officer. “Based on the initial results from this 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.”