Eclipse Life Sciences, Inc., a privately held clinical-stage biopharmaceutical company developing next-generation therapies for retinal diseases, 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.