Industry

Eclipse Life Sciences Completes Enrollment in Phase 2 BETTIS-1 Trial for EC-104 in DME

Eyewire+1d ago2 min read

Key Takeaways Eclipse Life Sciences has completed patient enrollment in its phase 2 BETTIS-1 trial evaluating EC-104, a 6-month sustained-release fluocinolone acetonide implant for DME The randomized, controlled study compares two EC-104 doses against Ozurdex in patients with suboptimal anti-VEGF response Topline data are expected in fall 2026 Eclipse Life Sciences announced it has completed patient enrollment in its BETTIS-1 phase 2 clinical trial evaluating EC-104 fluocinolone acetonide (FA) extended release for the treatment of diabetic macular edema (DME). EC-104 is a next-generation intravitreal corticosteroid implant designed to provide up to 6 months of sustained drug release. The company views the completion of enrollment as a key step forward in advancing the therapy through clinical development. “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, Chief Executive Officer and Vice President 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 US-based, randomized, controlled, double-masked phase 2 study comparing two doses of EC-104 (FA 0.14 mg and FA 0.092 mg) against Ozurdex (Abbvie; dexamethasone intravitreal implant 0.7 mg). The study is enrolling patients with DME who have shown a suboptimal response to intravitreal anti-vascular endothelial growth factor (VEGF) therapy and who have previously tolerated corticosteroids without clinically significant increases in IOP. The trial’s primary endpoint focuses on safety, while secondary endpoints include evaluation of anatomical durability using spectral domain-optical coherence tomography (SD-OCT) and changes in best-corrected visual acuity at 24 weeks. Eclipse Life Sciences continues to expand its ophthalmology pipeline beyond EC-104. The company is also developing EC-303, an investigational intravitreal therapy for intermediate (drusen-stage) dry age-related macular degeneration (AMD), and EC-501, a 6-month sustained-release anti-VEGF biologic for wet AMD, DME, and other retinal vascular diseases.

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AI Summary

Quick Take

Eclipse Life Sciences has completed patient enrollment for its Phase 2 BETTIS-1 trial evaluating EC-104, a 6-month sustained-release fluocinolone acetonide implant for diabetic macular edema (DME). The study compares two doses of the novel implant against the standard-of-care Ozurdex in patients who have shown a suboptimal response to traditional anti-VEGF therapy.

Why It Matters

While anti-VEGF injections are the gold standard for DME, a significant subset of patients fails to achieve total fluid resolution or experiences a heavy treatment burden. Corticosteroids are a potent alternative, but their utility is often limited by short durability or concerns regarding intraocular pressure (IOP) spikes. EC-104 aims to provide a reliable six-month treatment window, potentially offering a more sustainable long-term management strategy for 'suboptimal responders' who have already demonstrated steroid tolerance.

Key Findings

The trial is evaluating two distinct concentrations of the fluocinolone acetonide implant: 0.14 mg and 0.092 mg.
EC-104 is being compared directly against the 0.7 mg dexamethasone intravitreal implant (Ozurdex).
The primary endpoint of the BETTIS-1 trial is safety, specifically monitoring for adverse events associated with sustained-release steroids.
Secondary endpoints include anatomical durability measured by spectral domain-optical coherence tomography (SD-OCT) and changes in best-corrected visual acuity (BCVA).
The implant is engineered to provide a consistent drug release profile for up to 6 months.

Study Snapshot

Design

Randomized, controlled, double-masked Phase 2 study

Population

Patients with DME and suboptimal anti-VEGF response who have previously tolerated corticosteroids without significant IOP increases

Practice Implications

Retina specialists should watch for the 2026 data to see if EC-104 can reduce the injection burden for difficult DME cases. If safety profiles remain favorable in patients with known steroid tolerance, this could become a primary 'switch' therapy for patients who plateau on monthly anti-VEGF protocols.

Who's Affected

Retina SpecialistsOphthalmologistsPractice Owners

What's Next

Topline data from the BETTIS-1 trial is expected to be released in the fall of 2026. Eclipse is also progressing with its pipeline, including EC-303 for intermediate dry AMD and EC-501, a 6-month anti-VEGF biologic.

Evidence StrengthPreliminary

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