Eclipse Life Sciences, Inc. announced positive topline results from the phase 2 BETTIS-1 trial comparing EC-104 fluocinolone acetonide (FA) extended release versus OZURDEX for the treatment of diabetic macular edema (DME).
Give me a refresher on Eclipse Life Sciences.
The Research Triangle Park, North Carolina-based, privately-held, clinical-stage biopharmaceutical company was launched in 2021 as a startup stemming from the research commercialization arm of Duke University.
While EC-104 is the company’s lead asset, it currently has four other candidates in preclinical testing, including:
- EC-303 (IVT Mito XR): a novel mitochondria-targeted prodrug for dry age-related macular degeneration (AMD)
- EC-501 (IVT anti-VEGF XR): a 6-month ranibizumab biosimilar for wet AMD, DME, and macular edema following retinal vein occlusion (RVO)
- EC-401 (IVT CaM-I): a novel anti-inflammatory prodrug for wet AMD and DME
- EC-207 (Topical CaM-I): a novel eyedrop for dry eye disease (DED)
What do I need to know about EC-104?
EC-104 is a novel, completely biodegradable intravitreal (IVT) corticosteroid implant designed to deliver approximately 6 months of durable drug release for treating DME.
Its potential: to reduce treatment burden for patients who struggle with frequent injections and insufficient response to anti-VEGF therapies.
Understood. Moving on to the phase 2 study…
Dubbed “BETTIS-1,” this is a prospective, randomized, subject- and evaluator-masked, multicenter phase 2 study (NCT06536491)
Its purpose: to evaluate the safety and efficacy of the EC-104 FA implant in two doses compared to a marketed product IV injection (dexamethasone).
The details:
- Participants: estimated 75 (aged 18+)
- Criteria: diagnosis of diabetes mellitus (Type 1 or Type 2)
- history of DME prior to screening
- previous suboptimal response to anti-VEGF therapy
- previously treated with locally administered corticosteroids without a clinically significant increase in intraocular pressure (IOP)
- Criteria: diagnosis of diabetes mellitus (Type 1 or Type 2)
- The setup: patients randomized (1:1:1) to receive:
- EC-104 6M high-dose (FA 0.14 mg) implant
- EC-104 4M low-dose (FA 0.092 mg) implant
- OZURDEX (dexamethasone IVT implant, 0.7 mg)
- The study duration: 9 months
So what’s being measured?
Measured through Week 24, Clinical Trials noted the following:
- Primary outcome: ocular and systemic safety, as measured via adverse events (AEs)
- Secondary outcome: DME recurrence (measured in days)
And these topline findings?
The BETTIS‑1 trial met its primary endpoint, demonstrating a favorable safety profile across both EC-104 formulations compared to OZURDEX, with low rates of treatment-related AEs and no unexpected safety signals.
Moreover: At 24 weeks (and compared to OZURDEX), the secondary endpoints demonstrated superior clinically meaningful and durable improvement in both
- Best-corrected visual acuity (BCVA)
- Optical coherence tomography (OCT) central subfield thickness (CST).
In addition: patients with prior corticosteroid tolerance maintained acceptable IOP outcomes in both formulation arms.
Any comments from the company?
“The 6-month durability, consistent anatomical response, and strong safety profile reinforce EC-104’s potential to meaningfully reduce treatment burden” said Scott Cousins, MD, CEO, and VP for Research and Development at Eclipse Life Sciences.
He added: “EC-104 continues to show promise as a differentiated corticosteroid option for patients who need longer lasting treatment.”
When can I expect an update?
Eclipse Life Sciences plans to discuss phase 3 development of EC-104 with regulatory authorities, and is exploring partnership opportunities to accelerate phase 3 initiation and global commercialization to initiate a pivotal program in 2027.
Plus: Full BETTIS-1 data will be presented at an unspecified upcoming ophthalmology conference and submitted for publication in a peer-reviewed journal.