RESEARCH TRIANGLE PARK, N.C., Oct. 15, 2026 (GLOBE NEWSWIRE) — Eclipse Life Sciences, Inc., a privately held clinical-stage biopharmaceutical company developing next-generation therapies for retinal diseases, today announced positive topline results from its BETTIS-1 Phase 2 clinical trial comparing EC-104 fluocinolone acetonide (FA) extended release versus Ozurdex® for the treatment of diabetic macular edema (DME). EC-104 is a novel, completely biodegradable intravitreal corticosteroid implant engineered to deliver approximately six months of durable drug release.
The BETTIS‑1 trial met its primary endpoint, demonstrating a favorable safety profile across both EC-104 formulations compared to Ozurdex®. Secondary endpoints showed superior clinically meaningful and durable improvement in both best corrected visual acuity and OCT central subfield thickness at 24 weeks, when compared to Ozurdex®. The superiority of EC-104 was demonstrated in a study population of subjects with a previous suboptimal response to anti-VEGF therapy, which represents a significant unmet need and commercial opportunity.
“These results position EC-104 as a highly competitive candidate in the DME landscape,” said Scott Cousins, MD, CEO and VP for Research and Development at Eclipse Life Sciences. “The six-month durability, consistent anatomical response, and strong safety profile reinforce EC-104’s potential to meaningfully reduce treatment burden. EC-104 continues to show promise as a differentiated corticosteroid option for patients who need longer lasting treatment. We believe these data support advancement into Phase 3 and create a compelling opportunity for strategic collaboration.”
Phase 2 BETTIS-1 Topline Findings
- Primary Endpoint Achieved: EC-104 demonstrated a favorable safety profile with low rates of treatment-related adverse events and no unexpected safety signals.
- Durable Anatomical Response: Both EC-104 formulation groups showed sustained reductions in central subfield thickness (CST) through 24 weeks, consistent with the implant’s six-month release profile.
- Clinical Benefit in Anti-VEGF-Resistant Subjects: Subjects with documented suboptimal response to prior anti-VEGF therapy exhibited clinically meaningful anatomical improvements, reinforcing EC-104’s potential role as an alternative treatment.
- Intraocular Pressure (IOP) Profile: Patients with prior corticosteroid tolerance maintained acceptable IOP outcomes in both formulation arms.
“These results highlight the potential of EC-104 to reduce treatment burden for patients who struggle with frequent injections and insufficient response to anti-VEGF therapies,” said Victor H. Gonzalez, MD, retina specialist and Founder, Gulf Coast Eye Institute in McAllen, Texas. “An authentic six-month sustained release intravitreal corticosteroid option will be a significant advancement for this population.”
Strategic Opportunity
With strong Phase 2 data and a well-defined path for late-stage clinical development, regulatory approval and commercialization, Eclipse Life Sciences is exploring partnership opportunities to accelerate Phase 3 initiation and global commercialization. EC-104’s profile positions it as a differentiated entrant in the multi-billion-dollar DME market where durability and efficacy drive adoption.
Next Steps
Eclipse Life Sciences plans to engage with regulatory authorities to discuss Phase 3 development of EC-104 and expects to initiate a pivotal program in 2027. Full BETTIS-1 data will be presented at an upcoming ophthalmology conference and will be submitted for publication in a peer-reviewed journal.
About Diabetic Macular Edema (DME)
DME is the leading cause of vision loss among working-age adults. Although standard of care is initiating treatment with anti-VEGF therapies, many patients experience suboptimal response and require alternative treatments. Intravitreal corticosteroids play a critical role in addressing neuroinflammatory pathways in DME.
About Eclipse Life Sciences, Inc.
Eclipse Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for ophthalmic diseases. In addition to EC-104, Eclipse is advancing EC-303 for intermediate dry age-related macular degeneration (AMD) and EC-501, a six-month anti-VEGF therapy candidate for wet AMD, DME, and macular edema following retinal vein occlusion (RVO).
Investigational product. Not approved by regulatory authorities.
For media inquiries: 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.
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