Clearside Biomedical (NASDAQ:CLSD) enrolled the first patient in the Phase 2 TYBEE clinical trial of CLS-TA for suprachoroidal administration used together with intravitreally administered EYLEA for the treatment of diabetic macular edema (DME).
In the trial, patients with DME will be randomized into either a combination arm of patients receiving suprachoroidal CLS-TA together with intravitreal Eylea or a control arm of patients receiving only intravitreal Eylea.
The primary outcome measure will be a comparison between the two study arms of change from baseline in best-corrected visual acuity at three months.
“We believe that eye complications associated with diabetes are caused by multiple pathways in this difficult to treat disease, and that we can improve the visual outcomes for newly diagnosed DME patients by administering suprachoroidal CLS-TA together with an intravitreal anti-VEGF inhibitor like Eylea,” Daniel White, president and CEO of Clearside, said in a statement.
“The enrollment of the first patient in the TYBEE trial represents an important step forward in Clearside’s DME clinical development program and we currently expect to report three-month preliminary data in the first half of 2018,” he added.
CLS-TA for suprachoroidal administration, used either alone or together with an intravitreal anti-VEGF agent, is part of Clearside’s pipeline for the treatments of unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina.