Eclipse Life Sciences, Inc. has kicked off a phase 2 clinical trial evaluating the use of a novel intravitreal (IV) corticosteroid implant for diabetic macular edema (DME) with the enrollment and dosing of its first patient.
I’m not familiar with this company …
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.
- Its focus: Developing novel IVT therapies for ophthalmic diseases, including:
- Posterior: uveitis; dry eye
- Anterior: intermediate dry age-related macular degeneration (AMD); wet AMD; diabetic retinopathy (DR); DME; other retinal vascular diseases
Now let’s zero in on this implant.
EC-104 fluocinolone acetonide (FA) extended release is an IV corticosteroid designed with an intended 6 months of durable drug release for treating DME.
Its potential: To improve vision among DME patients via a twice-yearly dosing schedule—with a specific purpose of targeting those with a suboptimal response to IVT anti-vascular endothelial growth factor (VEGF) medications, according to Ivan Suñer, MD, principal investigator of the phase 2 trial.
Talk about the trial.
Dubbed “BETTIS-1,” the prospective, randomized, subject- and evaluator-masked, multicenter phase 2 study (NCT06536491) is evaluating 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
- 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)
- Also: The company stated that this outcome measure is an assessment of “efficacy as reflected by the anatomic durability of treatment response by spectral domain-optical coherence tomography (SD-OCT).”
What are investigators hoping to achieve?
Reportedly, an estimated 20 patients per group (out of the three) with a positive therapeutic response in their study eyes are then “evaluable in the primary endpoint analysis to assess efficacy.”
Also: Participants who demonstrate a positive therapeutic response at Week 4 will then be “included in the primary and secondary endpoint analyses” to determine the efficacy of the EC-104 FA implant.
- Note: Patients who don’t achieve a positive therapeutic response will be labeled as “suboptimal responders” and not included in the primary/secondary endpoint analyses.
And where is the study being conducted?
According to Clinical Trials, one location is verified: Retina Associates of Florida, LLC, based in Tampa, Florida.
However, Scott Cousins, Eclipse Life Sciences CEO and president for Research and Development, noted that “multiple clinical trial sites (are) now active across the U.S.”
Lastly, when can we expect data?
The study is slated to conclude in December 2025 … so stay tuned.