The first patients have been dosed in a phase 2 trial for EC-104 fluocinolone acetonide (FA) extended release, a new intravitreal corticosteroid implant designed to treat diabetic macular edema (DME) with a six-month drug release, biopharmaceutical company Eclipse Life Sciences recently announced. 

The randomized, controlled, double-masked BETTIS-1trial will compare two doses of EC-104 (FA 0.14 mg and FA 0.092 mg) to Ozurdex (dexamethasone intravitreal implant 0.7 mg, AbbVie) in patients with DME who have shown suboptimal response to intravitreal anti-VEGF therapy and who previously have been treated with corticosteroids without a clinically significant rise in intraocular pressure. The trial’s primary endpoint is safety, with secondary focus on treatment durability assessed via spectral domain-optical coherence tomography (SD-OCT) through week 24.

“Initiating this clinical trial for EC-104 represents an important milestone for Eclipse, as we advance a novel 6-month corticosteroid implant to improve outcomes and enhance quality of life for patients with DME,” said Scott Cousins, MD, CEO of Eclipse Life Sciences.