Clearside completes patient enrollment in Phase 2 DME trial
Clearside Biomedical (NASDAQ:CLSD) completed patient enrollment in the Phase 2 TYBEE clinical trial of suprachoroidal CLS-TA together with intravitreally administered Eylea for the treatment of diabetic macular edema (DME).
Patient follow-up in the TYBEE trial is six months. The trial enrolled 71 patients who are naïve to pharmacologic treatment for DME. Patients were randomized into either a combination arm to receive suprachoroidal CLS-TA together with intravitreal Eylea or a control arm to receive only intravitreal Eylea.
The primary outcome measure is a comparison of mean change from baseline in best-corrected visual acuity between the two study arms. An additional analysis will be a comparison between the number of injections required between the two groups.
“The completion of patient enrollment in the TYBEE trial represents an important milestone and step forward in our DME clinical development program,” president and CEO, Daniel White, said in a statement. More than 300 patients have been treated for sight threatening diseases with suprachoroidal CLS-TA.
“We believe that eye complications associated with diabetes are caused by multiple pathways and, despite the use of anti-VEGF drugs, there remains a significant unmet need,” he added.
Mr. White said that even with repeated monthly injections for six months, approximately 40% of DME patients have an insufficient response to treatment.
“We believe that we can improve the visual outcomes for newly diagnosed DME patients by administering suprachoroidal CLS-TA together with an intravitreal anti-VEGF inhibitor because both corticosteroids and anti-VEGF agents have been shown to be effective in the treatment of DME,” he added.