Eclipse Life Sciences completes enrollment in BETTIS-1 phase 2 clinical trial

Eclipse Life Sciences has completed patient enrollment in its BETTIS-1 phase 2 clinical trial (NCT06536491) evaluating EC-104 fluocinolone acetonide (FA) extended release for the treatment of diabetic macular edema (DME).

The company describes EC-104 as “a next-generation intravitreal corticosteroid implant designed to provide 6 months of durable drug release.”¹

The phase 2 trial is a randomized, subject- and evaluator-masked, multicenter study. The trial will compare the safety and efficacy of EC-104-6M high-dose (FA 0.14 mg) and EC-104-4M low-dose (FA 0.092 mg) to Ozurdex (dexamethasone intravitreal (IVT) implant, 0.7 mg). Patients enrolled have demonstrated a suboptimal clinical response to intravitreal anti-vascular endothelial growth factor (VEGF) therapy and have previously tolerated locally administered corticosteroids without clinically significant intraocular pressure (IOP) elevation.²

Approximately 75 patients are enrolled in the trial, with the goal of evaluating 20 patients per treatment group. Patients with a positive therapeutic response at week 4 will be included in the primary and secondary endpoint analyses to assess efficacy for "time to recurrent disease." Patients who do not achieve a positive response will be excluded from the primary and secondary endpoints but will remain in the study and be monitored through week 24.²

The primary endpoint of the trial is an assessment of safety, while secondary endpoints will look at the recurrence of DME over 24 weeks.

Scott Cousins, MD, CEO and VP for research and development at Eclipse Life Sciences, commented on the trial in a press release from the company, saying, “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.”

Besides EC-104, Eclipse Life Sciences is also working on EC-303, a new IVT drug for treating intermediate dry AMD, and EC-501, a new long-lasting anti-VEGF drug for treating wet AMD, DME, and other eye blood vessel diseases, along with several other experimental drugs in development.³

References:

1. Eclipse Life Sciences Completes Enrollment in Phase 2 Study Evaluating EC-104 for Diabetic Macular Edema (DME). Published April 13, 2026. Accessed April 13, 2026. https://www.globenewswire.com/news-release/2026/04/13/3272363/0/en/Eclipse-Life-Sciences-Completes-Enrollment-in-Phase-2-Study-Evaluating-EC-104-for-Diabetic-Macular-Edema-DME.html

2. EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema (BETTIS-1). NCT06536491. Accessed April 13, 2026. https://clinicaltrials.gov/study/NCT06536491?term=NCT06536491&rank=1&tab=researcher

3. Crago SM. Eclipse Life Sciences enrolls and doses first patient in BETTIS-1 Phase 2 clinical trial. Published August 17, 2024. Accessed April 13, 2026. https://www.ophthalmologytimes.com/view/eclipse-life-sciences-enrolls-and-doses-first-patient-in-bettis-1-phase-2-clinical-trial