Eclipse Life Sciences Starts Phase 2 Trial for New DME Steroid Implant

Eclipse Life Sciences, Inc., a clinical-stage biopharmaceutical company based in Research Triangle Park, N.C., has announced the enrollment and dosing of its first patient in the BETTIS-1 Phase 2 clinical trial. This trial is evaluating EC-104 fluocinolone acetonide (FA) extended release, a new intravitreal (IVT) corticosteroid implant designed to release medication over six months, for the treatment of diabetic macular edema (DME).

Scott Cousins, MD, the CEO and VP for Research and Development at Eclipse Life Sciences, highlighted the significance of this milestone. According to Dr. Cousins, the initiation of this trial marks a critical step forward for their novel 6-month corticosteroid implant aimed at improving patient outcomes and quality of life for those suffering from DME. Multiple clinical trial sites have already become active across the United States, and the company is eager to continue enrolling participants in the BETTIS-1 trial as part of the broader EC-104 clinical development program.

The BETTIS-1 trial is a randomized, controlled, double-masked Phase 2 study. It compares two different doses of EC-104 (0.14 mg and 0.092 mg) to Ozurdex® in patients with DME who have shown a suboptimal clinical response to IVT anti-vascular endothelial growth factor (VEGF) therapy, and who have previously been treated with locally administered corticosteroids without significant increases in intraocular pressure (IOP). The primary goal of the BETTIS-1 trial is to assess the safety of EC-104 in the target population, while the secondary objective is to evaluate its efficacy, specifically the anatomical durability of the treatment response measured by spectral domain-optical coherence tomography (SD-OCT) through week 24.

Dr. Ivan Suñer, the principal investigator for the BETTIS-1 trial and a specialist at Retina Associates of Florida, Tampa, emphasized the potential benefits of EC-104. He noted that a safe and effective IVT corticosteroid implant with a proven duration of effect for six months is a significant unmet clinical need for DME patients. EC-104 could offer improved vision with the convenience of twice-a-year dosing, particularly benefiting patients who have not responded well to IVT anti-VEGF treatments.

Diabetic macular edema (DME) is the primary cause of vision loss among working-age adults in the United States. Approximately 65% of DME patients do not respond adequately to IVT anti-VEGF monotherapy and could benefit from IVT corticosteroid therapy. EC-104 is designed to meet this clinical need, providing a durable 6-8 month IVT corticosteroid therapy option for patients resistant to anti-VEGF treatments.

Eclipse Life Sciences is dedicated to discovering and developing new therapies for ophthalmic diseases. Besides EC-104, the company is also advancing EC-303, an IVT drug for intermediate dry age-related macular degeneration (AMD), and EC-501, a 6-month durable anti-VEGF drug for treating wet AMD, DME, and other retinal vascular diseases. The company has a robust pipeline of investigational drugs in development, aimed at addressing various ophthalmic conditions.