Eclipse Life Sciences announced positive top-line results from its BETTIS-1 phase 2 clinical trial comparing EC-104 fluocinoloneacetonide extended release vs dexamethasone intravitreal implant (Ozurdex; AbbVie) for the treatment of diabetic macular edema (DME). EC-104 is a novel, completely biodegradable intravitreal corticosteroid implant engineered to deliver approximately 6 months of durable drug release, the company said in a press release.

According to the company, 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.

EC-104 demonstrated a favorable safety profile with low rates of treatment-related adverse events and no unexpected safety signals. Both EC-104 formulation groups showed sustained reductions in central subfield thickness through 24 weeks, consistent with the implant’s 6-month release profile. Subjects with a documented suboptimal response to prior anti-VEGF therapy exhibited clinically meaningful anatomical improvements, reinforcing EC-104’s potential role as an alternative treatment. Patients with prior corticosteroid tolerance maintained acceptable intraocular pressure outcomes in both formulation arms.

Eclipse Life Sciences said it plans to engage with regulatory authorities to discuss phase 3 development of EC-104 and expects to initiate a pivotal program in 2027. RP