A phase 2 clinical trial of suprachoroidal CLS-TA with Eylea met its primary endpoint of mean improvement in best corrected visual acuity in patients with diabetic macular edema, Clearside Biomedical announced in a press release.
The multicenter, randomized, masked, controlled TYBEE trial included 71 patients randomly assigned to receive either quarterly treatments of suprachoroidal CLS-TA together with intravitreal Eylea (aflibercept, Regeneron) or four monthly treatments of Eylea with a sham suprachoroidal procedure, the release said.
At 6 months, patients in the combination arm gained an average of 12.3 ETDRS letters, while those in the control arm averaged a gain of 13.5 ETDRS letters. The difference was not statistically significant.
“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,” Daniel White, Clearside CEO and president, said in the release.
The trial also found a mean reduction of 208 µm in central subfield thickness of the retina from baseline in patients who received suprachoroidal CLS-TA compared with a mean reduction of 177 µm in the control arm.