Eclipse Life Sciences Completes Enrollment in Phase 2 Trial of EC-104 for Diabetic Macular Edema
核心洞察
Eclipse Life Sciences (搜索) has completed patient enrollment in its BETTIS-1 Phase 2 clinical trial evaluating EC-104, a next-generation intravitreal corticosteroid implant for diabetic macular edema (搜索) treatment.
The randomized, controlled study compares two doses of EC-104 fluocinolone acetonide to Ozurdex in patients with suboptimal anti-VEGF (搜索) therapy response.
EC-104 is designed to provide six months of durable drug release, addressing an unmet need for patients with anti-VEGF (搜索)-resistant diabetic macular edema (搜索).
Eclipse Life Sciences (搜索) has reached a significant milestone in its development of EC-104, completing patient enrollment in the BETTIS-1 Phase 2 clinical trial for diabetic macular edema (搜索) (DME (搜索)). The study evaluates EC-104 fluocinolone acetonide extended release, a next-generation intravitreal corticosteroid implant designed to provide six months of sustained drug delivery.
"Completing enrollment in the BETTIS-1 trial marks a significant milestone for Eclipse as we advance EC-104 through clinical development," said Scott Cousins, MD, CEO and VP for Research and Development at Eclipse Life Sciences (搜索). "We are grateful to the investigators, clinical trial site teams, and patients who have contributed to this important study. With all participants now enrolled, we look forward to the upcoming data readout this Fall 2026 and the opportunity to further understand the safety and therapeutic potential of EC-104."
Trial Design and Patient Population
The BETTIS-1 trial is a U.S.-based, randomized, controlled, double-masked Phase 2 study comparing two doses of EC-104 (FA 0.14 mg and FA 0.092 mg) to Ozurdex (dexamethasone intravitreal implant 0.7 mg). The study specifically targets patients with DME (搜索) who have demonstrated a suboptimal clinical response to intravitreal anti-vascular endothelial growth factor (搜索) (VEGF (搜索)) therapy and who have previously tolerated locally administered corticosteroids without clinically significant intraocular pressure (IOP) elevation.
The primary endpoint focuses on safety assessment, while secondary endpoints evaluate anatomical durability of treatment response through spectral domain-optical coherence tomography (SD-OCT) and changes in best-corrected visual acuity at the 24-week timepoint.
Addressing Unmet Medical Need
DME (搜索) represents a leading cause of vision loss among working-age adults in the United States. Many patients experience suboptimal outcomes with anti-VEGF (搜索) monotherapy and subsequently benefit from intravitreal corticosteroid therapy.
"Patients with DME (搜索) continue to face substantial treatment burden, particularly those who do not respond adequately to anti-VEGF (搜索) therapy. This remains a significant unmet need," said Victor H. Gonzalez, MD, retina specialist and founder of Gulf Coast Eye Institute, McAllen, Texas.
David S. Dyer, MD, retina specialist and founder of Retina Associates (搜索), LLC, Kansas City, Missouri, emphasized the potential clinical significance: "A corticosteroid implant capable of delivering a consistent six-month duration of effect represents an important advancement for this population since there is no comparable commercially available product. We look forward to the study results."
Drug Development Strategy
EC-104 is designed to address the unmet need for a durable, 6- to 8-month intravitreal corticosteroid option for patients with anti-VEGF (搜索)-resistant DME (搜索). The extended-release formulation aims to reduce treatment burden while maintaining therapeutic efficacy.
Eclipse Life Sciences (搜索) is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for ophthalmic diseases. Beyond EC-104, the company is advancing EC-303, a novel intravitreal therapy for intermediate (drusen-stage) dry age-related macular degeneration (搜索) (AMD (搜索)), and EC-501, a six-month sustained-release anti-VEGF (搜索) biologic for wet AMD, DME (搜索), and other retinal vascular diseases.
The completion of enrollment positions Eclipse for data readout in Fall 2026, which will provide crucial insights into the safety and therapeutic potential of this investigational treatment approach for patients with treatment-resistant diabetic macular edema (搜索).