RESEARCH TRIANGLE PARK, N.C., April 13, 2026 (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 completed patient enrollment in its BETTIS-1 Phase 2 clinical trial evaluating EC-104 fluocinolone acetonide (FA) extended release, a next-generation intravitreal corticosteroid implant designed to provide six months of durable drug release for the treatment of diabetic macular edema (DME).
“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. “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.”
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) in patients with DME who have demonstrated a suboptimal clinical response to intravitreal anti-vascular endothelial growth factor (VEGF) therapy and who have previously tolerated locally administered corticosteroids without clinically significant intraocular pressure (IOP) elevation. The primary endpoint is an assessment of safety, with secondary endpoints evaluating anatomical durability of treatment response through spectral domain-optical coherence tomography (SD-OCT) and change in best-corrected visual acuity, at the 24-week timepoint.
“Patients with DME continue to face substantial treatment burden, particularly those who do not respond adequately to anti-VEGF 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, LLC, Kansas City, Missouri, concurs, “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.”
About Diabetic Macular Edema (DME)
DME is a leading cause of vision loss among working-age adults in the United States.1 Many patients experience suboptimal outcomes with anti-VEGF monotherapy2 and subsequently benefit from intravitreal corticosteroid therapy. EC-104 is designed to address the unmet need for a durable, 6- to 8-month intravitreal corticosteroid option for patients with anti-VEGF-resistant DME.
About Eclipse Life Sciences, Inc.
Eclipse Life Sciences is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapies for ophthalmic diseases. In addition to EC-104, Eclipse is advancing EC-303, a novel intravitreal therapy for intermediate (drusen-stage) dry age-related macular degeneration (AMD), and EC-501, a six-month sustained-release anti-VEGF biologic for wet AMD, DME, and other retinal vascular diseases, along with a growing pipeline of additional investigational drug products.
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: EC-104 is an investigational drug product. Not approved by regulatory authorities.
For more information or press inquiries, please contact: info@eclipselifesciences.com
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.
