Clearside Biomedical’s Phase 1/2 Open Label Clinical Trial of CLS-TA With and Without Eylea in Diabetic Macular Edema Presented at the American Academy of Ophthalmology 2017 Annual Meeting
DME is the most common cause of vision loss in people with diabetes mellitus. A consequence of diabetic retinopathy, DME is swelling of the retina caused by leaking blood vessels. DME affects up to 30% of people who have had diabetes for 20 years or more, and if untreated, approximately 20 to 30% of people who have it will experience moderate visual loss.
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.
Dr. Wykoff commented, “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.”
“We believe that eye complications associated with diabetes are caused by multiple pathways,” commented Dr.
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.
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Source: Clearside Biomedical, Inc.