Charles C. Wykoff, MD, PhD, presented preliminary results from an exploratory clinical trial (the HULK trial) of CLS-TA, Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide for suprachoroidal administration, with and without intravitreally injected Eylea (aflibercept) for the treatment of diabetic macular edema (DME).
In April 2017, Clearside completed patient enrollment in the HULK trial, an open-label, multicenter phase 1/2 clinical trial designed to assess the safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal Eylea in 10 patients with DME who are naïve to treatment. The trial is also assessing the safety and efficacy of suprachoroidal CLS-TA alone in 10 patients with DME who have previously been treated with intravitreal anti-VEGF agents or intravitreal corticosteroids and still require further treatment.
The HULK trial findings presented by Dr. Wykoff at AAO 2017 showed a visual benefit for patients receiving CLS-TA, with a greater benefit in treatment naïve eyes. Anatomic improvement was observed in all treated eyes, with more than two-thirds of those eyes achieving a greater than 50% reduction in excess central retinal thickness based on monthly measurements through 6 months after initial treatment. In the treatment naïve group, 40% of patients did not require retreatment over the entire 6 months, with an additional 20% requiring only one retreatment. Suprachoroidal CLS-TA, including in patients who received as many as five injections, was well tolerated, with a low incidence of ocular side effects, including IOP elevations.
“While the current standard of care most commonly used to treat patients with DME is use of intravitreal anti-VEGF agents, there is still a significant unmet need in this large patient population," Dr. Wykoff said. "These initial results from the HULK study suggest encouraging efficacy with a trend toward durability, particularly in the combination treatment arm.”
“We believe that eye complications associated with diabetes are caused by multiple pathways,” Dr. Richard Beckman, Chief Medical Officer of Clearside, said in a company news release. “As a result, even with repeated monthly injections for 6 months, approximately 40% of DME patients have an insufficient response to treatment with anti-VEGF agents alone. We believe that suprachoroidal CLS-TA, used together with an intravitreal anti-VEGF agent, has the potential to improve treatment outcomes and reduce the treatment burden for newly diagnosed DME patients, as both corticosteroids and anti-VEGF agents have been shown to be effective in the treatment of DME. To that end, we are completing patient follow-up in our TYBEE trial, a controlled, randomized, masked phase 2 clinical trial of CLS-TA used together with Eylea in patients who are naïve to treatment for their DME, and expect to release preliminary data from this trial in the second quarter of 2018.”
Suprachoroidal CLS-TA, 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.