Eclipse Life Sciences' EC-104 implant beats Ozurdex in Phase 2 DME trial
Eclipse Life Sciences has reported positive topline results from BETTIS-1, its Phase 2 trial pitting EC-104 against Ozurdex (dexamethasone intravitreal implant) in patients with diabetic macular edema. The North Carolina biotech said the trial met its primary endpoint on safety and demonstrated statistically superior outcomes on secondary measures of vision and retinal anatomy.
EC-104 is a biodegradable intravitreal implant loaded with fluocinolone acetonide and engineered for approximately six months of sustained drug release. The BETTIS-1 dataset is notable for its enrolled population: subjects with a documented suboptimal response to prior anti-VEGF therapy, a cohort that represents a genuine clinical gap where no approved corticosteroid implant currently holds a dominant position.
Trial findings
Both EC-104 formulation arms showed sustained reductions in central subfield thickness through 24 weeks, aligning with the implant's stated release kinetics. Best corrected visual acuity also improved compared with Ozurdex. The safety readout included an assessment of intraocular pressure, a longstanding concern with intravitreal corticosteroids; the company said patients with prior corticosteroid tolerance maintained acceptable IOP outcomes, though full data have not yet been published.
Scott Cousins, chief executive and VP for research and development at Eclipse Life Sciences, said the six-month durability and anatomical consistency "reinforce EC-104's potential to meaningfully reduce treatment burden" and described the data as supporting advancement into Phase 3 and a search for strategic partners.
Eclipse plans to engage regulators on a Phase 3 design and expects to initiate a pivotal programme in 2027. Full BETTIS-1 data will be presented at an upcoming ophthalmology conference and submitted for peer-reviewed publication.
Market context
The DME treatment landscape is dominated by anti-VEGF agents, including ranibizumab, aflibercept and the newer faricimab, all of which require frequent intravitreal injections. Ozurdex, marketed by AbbVie, and Alimera Sciences' Iluvien (also a fluocinolone acetonide implant, with a longer release duration of up to 36 months) occupy the corticosteroid niche. EC-104's positioning in the anti-VEGF non-responder population gives it a clinically distinct entry point rather than direct head-to-head competition with the VEGF standard of care.
The broader DME market is growing as diabetic retinopathy prevalence rises globally alongside rates of type 2 diabetes. Durability of effect is increasingly valued by both patients and retina specialists managing large, injection-heavy clinic schedules, and a genuine six-month biodegradable option could command meaningful adoption if Phase 3 replicates the BETTIS-1 signal.
Eclipse also carries two other ophthalmic pipeline assets: EC-303 for intermediate dry age-related macular degeneration and EC-501, an anti-VEGF candidate for wet AMD and macular oedema following retinal vein occlusion. The breadth of the pipeline strengthens the case for a partnership deal, though Eclipse remains privately held and has not disclosed its capital position or existing investor base. Potential partners and acquirers in the ophthalmology space have included Roche, Novartis and Apellis in recent years, and a well-packaged Phase 3-ready asset in retinal disease routinely attracts significant commercial interest.