A phase 2 trial of EC-104, a fluocinolone acetonide intravitreal implant, hit its primary safety endpoint in diabetic macular edema (DME) patients who previously had a suboptimal response to anti-VEGF therapy. The BETTIS-1 trial also showed superior improvements in visual acuity and retinal thickness compared to the dexamethasone implant at 24 weeks, with a clean safety profile — paving the way for a phase 3 study.
A new intravitreal implant is turning heads in the diabetic macular edema space. Eclipse Life Sciences announced that EC-104 — a fluocinolone acetonide extended-release implant — met its primary safety endpoint in the phase 2 BETTIS-1 trial. The study compared two doses (0.14 mg and 0.092 mg) against Ozurdex (dexamethasone implant) in DME patients who had previously responded poorly to anti-VEGF injections.
Beyond safety, secondary endpoints told an encouraging story: EC-104 delivered superior, clinically meaningful improvements in best corrected visual acuity and central subfield thickness at 24 weeks, with sustained anatomical benefits throughout. Adverse event rates were low, no unexpected safety signals emerged, and IOP outcomes were acceptable in patients with prior corticosteroid tolerance.
Key Takeaways:
Why it matters: Many DME patients plateau on anti-VEGF therapy and need durable alternatives. A 6-month corticosteroid implant with a strong safety and efficacy profile could meaningfully reduce treatment burden for this hard-to-treat population.
