RESEARCH TRIANGLE PARK, N.C., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Eclipse Life Sciences, Inc., a privately held clinical-stage biopharmaceutical company focused on the development of novel therapies for ophthalmic diseases, today announced that it has enrolled and dosed its first patient in the BETTIS-1 Phase 2 clinical trial (NCT06536491) for EC-104 fluocinolone acetonide (FA) extended release, a novel intravitreal (IVT) corticosteroid implant with intended 6 months durable drug release for the treatment of diabetic macular edema (DME).
“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 U.S., we look forward to continued enrollment in the BETTIS-1 trial as we advance the EC-104 clinical development program,” said Scott Cousins, MD, CEO and VP for Research and Development for Eclipse Life Sciences.
The BETTIS-1 trial is a randomized, controlled, double-masked, Phase 2 clinical trial comparing two 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, while 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.
“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,” said Ivan Suñer, MD, principal investigator in the BETTIS-1 trial, from Retina Associates of Florida, Tampa, FL. “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.”
About DME
DME is the leading cause of vision loss among working-age individuals in the U.S.1 Up to 65% of DME patients demonstrate suboptimal response to IVT anti-VEGF monotherapy2 and would thus benefit from an IVT corticosteroid therapy. EC-104 is positioned to meet the clinical unmet need for a 6-8 month durable IVT corticosteroid therapy for anti-VEGF resistant DME.
About Eclipse Life Sciences
Eclipse Life Sciences is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies for ophthalmic diseases. In addition to EC-104, Eclipse is also developing EC-303, a novel IVT drug for the treatment of intermediate (drusen-stage) dry age-related macular degeneration (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.
References:
- Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015;2:17.
- Rennie C, Lotery A, Payne J., et al. Suboptimal outcomes and treatment burden of anti-vascular endothelial growth factor treatment for diabetic macular oedema in phakic patients. Eye. 2015;38: 215–223.
Disclaimer: Investigational product. Not approved by regulatory authorities.
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Forward-Looking Statements: This press release contains forward-looking statements. Actual results may differ materially from those expressed or implied by such statements. Factors that could cause actual results to differ include clinical trial outcomes, regulatory decisions, and market conditions.
