Clearside Biomedical (NASDAQ:CLSD) presented preliminary results from the exploratory HULK clinical trial of CLS-TA, its proprietary suspension formulation of the corticosteroid, triamcinolone acetonide, for suprachoroidal administration (suprachoroidal CLS-TA), with and without intravitreally injected EYLEA for the treatment of diabetic macular edema (DME).
The results were presented at the American Academy of Ophthalmology 2017 Annual Meeting in New Orleans.
The HULK trial findings presented by Dr. Wykoff at AAO 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 six months after initial treatment.
In the treatment naïve group, 40% of patients did not require retreatment over the entire six 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 intraocular pressure elevations.
In a statement, Dr. Wykoff said that 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.
"These initial results from the HULK study suggest encouraging efficacy with a trend toward durability, particularly in the combination treatment arm," he added.
Dr. Richard Beckman, CMO of Clearside, said that even with repeated monthly injections for six 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," he added.
Clearside is completing patient follow-up in its 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. The company expects to release preliminary data from the trial in the second quarter of 2018.