BETTIS-1 Phase 2 trial enrolls and doses first patient with DME
EC-104 is a novel intravitreal (IVT) corticosteroid implant with intended 6 months durable drug release for the treatment of DME.
(Image credit: AdobeStock/NanSan)
Eclipse Life Sciences has enrolled and dosed its first patient in the BETTIS-1 Phase 2 clinical trial (NCT06536491) for EC-104 fluocinolone acetonide (FA) extended release. This candidate is a novel intravitreal (IVT) corticosteroid implant with intended 6 months durable drug release for the treatment of diabetic macular edema (DME).1
Scott Cousins, MD, CEO, and VP for Research and Development for Eclipse Life Sciences shared how this milestone marks the next stage in this trial program. In the press release,1 he said, “Initiating this clinical trial for EC-104 represents an important milestone for Eclipse, as we advance a novel 6-month corticosteroid implant to improve outcomes and enhance quality of life for patients with DME. With multiple clinical trial sites now active throughout the US, we look forward to continued enrollment in the BETTIS-1 trial as we advance the EC-104 clinical development program.”
The Phase 2 BETTIS-1 clinical trial is designed as a randomized, controlled, double-masked, trial comparing 2 doses (FA 0.14 mg and FA 0.092 mg) of EC-104 to Ozurdex, in patients with DME with prior suboptimal clinical response to IVT anti-vascular endothelial growth factor (VEGF) therapy and who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP). The primary endpoint for the BETTIS-1 trial is an assessment of safety of EC-104 in the study population. The secondary endpoint is an assessment of the efficacy as reflected by the anatomic durability of treatment response by spectral domain-optical coherence tomography (SD-OCT) through week 24.1
Ivan Suñer, MD, a principal investigator in the BETTIS-1 trial, from Retina Associates of Florida, Tampa, Florida, shared his thoughts on the potential of this treatment for patients with DME. He said, “A safe and effective IVT corticosteroid implant that provides a proven duration of effect for 6 months remains a significant clinical unmet need for patients with DME. EC-104 has the potential to offer the benefit of improved vision in convenient twice-a-year dosing, in particular for DME patients with a suboptimal response to IVT anti-VEGF medications.”1
In addition to EC-104, Eclipse Life Sciences is also developing EC-303, a novel IVT drug for the treatment of intermediate (drusen-stage) dry AMD and EC-501, a novel 6-month durable anti-VEGF drug for the treatment of wet AMD, DME, and other retinal vascular diseases, along with a pipeline of other investigational drugs in development.1
