Clearside Biomedical announced completion of enrollment of an exploratory clinical trial (HULK trial) of CLS-TA for suprachoroidal administration, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide, with or without intravitreal Eylea (aflibercept), for the treatment of diabetic macular edema (DME).
The HULK trial is an open-label, multicenter phase 1/2 study designed to assess the safety and efficacy of the administration of a suprachoroidal injection of CLS-TA along with an intravitreal injection of Eylea in patients with DME naïve to treatment, as well as that of a suprachoroidal injection of CLS-TA alone in patients with DME who have previously been treated with intravitreal anti-VEGF or intravitreal corticosteroid treatment and still require further treatment. Clearside currently expects to report preliminary results from the HULK trial in the second half of 2017.
"While the current standard of care in treating patients with DME is through the use of intravitreally delivered anti-VEGF agents, a significant unmet need remains in this large patient population. Approximately 40% of DME patients have an insufficient response to VEGF inhibitors. We believe that, by administering suprachoroidal CLS-TA with the potential to access the retina and choroid in high amount, concomitantly with intravitreal Eylea, there is the opportunity to more effectively treat DME when compared with current intravitreal anti-VEGF or corticosteroid therapies used alone,” Daniel H. White, Chief Executive Officer and President of Clearside, said in a company news release. “I would like to take this opportunity to thank the participating physicians and patients in the HULK trial, and to congratulate our team for working so diligently and effectively to complete study enrollment with the goal of addressing the needs of these patients. We are also in the process of final preparations to initiate a larger phase 2 trial in this blinding eye disease.”
Clearside currently expects to enroll the first patient in the planned multicenter, randomized, masked, controlled phase 2 trial (TYBEE trial) in mid-2017. TYBEE will evaluate suprachoroidal CLS-TA along with intravitreal Eylea, compared to intravitreal Eylea only, in patients with DME, over a 6-month evaluation period. The primary endpoint of the trial will be the change in best corrected visual acuity from baseline in the combination treatment arm compared to the intravitreal Eylea only arm.
Suprachoroidal CLS-TA, 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.