Key Takeaways

  • BETTIS-1 met its primary safety endpoint, with no unexpected safety signals reported for EC-104

  • EC-104 demonstrated sustained visual and anatomical improvements through 24 weeks compared with Ozurdex

  • Eclipse Life Sciences anticipates initiating phase 3 development in 2027

Eclipse Life Sciences announced positive topline results from its phase 2 BETTIS-1 clinical trial evaluating EC-104, a biodegradable intravitreal fluocinolone acetonide implant, for the treatment of diabetic macular edema (DME).

The trial met its primary endpoint, demonstrating a favorable safety profile for both EC-104 formulations compared with Ozurdex (dexamethasone intravitreal implant). According to the company, secondary endpoints showed superior, clinically meaningful improvements in best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) central subfield thickness (CST) at 24 weeks compared with Ozurdex.

EC-104 is designed to provide approximately 6 months of sustained corticosteroid delivery. The BETTIS-1 study evaluated patients with a history of suboptimal response to anti-VEGF therapy, a population with limited treatment options.

Both EC-104 formulation groups demonstrated sustained reductions in CST through 24 weeks. The company also reported low rates of treatment-related adverse events, no unexpected safety signals, and acceptable intraocular pressure outcomes among patients with prior corticosteroid tolerance.

“These results position EC-104 as a highly competitive candidate in the DME landscape,” said Scott Cousins, MD, CEO and vice president of research and development at Eclipse Life Sciences. “The 6-month durability, consistent anatomical response, and strong safety profile reinforce EC-104’s potential to meaningfully reduce treatment burden.”

The company did not provide numerical efficacy results, adverse event rates, or statistical comparisons in its topline announcement.

Eclipse Life Sciences plans to engage regulatory authorities regarding phase 3 development and expects to initiate a pivotal clinical program in 2027. The company is also exploring strategic partnerships to support late-stage development and commercialization.

Full BETTIS-1 results are expected to be presented at an upcoming ophthalmology conference and submitted for peer-reviewed publication.