Clearside Biomedical announced completion of patient enrollment in the phase 2 clinical trial (TYBEE) of CLS-TA, Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide for suprachoroidal administration (suprachoroidal CLS-TA), used together with intravitreally administered Eylea (aflibercept) for the treatment of diabetic macular edema (DME). Patient follow-up in the TYBEE trial is 6 months.
The TYBEE trial, a multicenter, randomized, masked, controlled phase 2 trial, has enrolled 71 patients who are naïve to pharmacologic treatment for DME. In this trial, 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. We have eclipsed over 300 patients who have been treated for sight threatening diseases with suprachoroidal CLS-TA,” Daniel H. White, Chief Executive Officer and President of Clearside, said in the news release. “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. Even with repeated monthly injections for 6 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.”
CLS-TA for suprachoroidal administration, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline for the treatments of unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina.