First patient dosed in phase 2 trial of EC-104 implant for diabetic macular edema
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Eclipse Life Sciences has enrolled and dosed the first patient in the BETTIS-1 phase 2 clinical trial investigating the EC-104 implant for the treatment of diabetic macular edema, according to a press release.
The randomized, controlled, double-masked trial will compare the extended release of 0.14 mg and 0.092 mg doses of EC-104 (fluocinolone acetonide) with Ozurdex (dexamethasone intravitreal implant, AbbVie) in patients with DME who had a previous suboptimal clinical response to intravitreal anti-VEGF therapy. Enrolled patients have also previously been treated with locally administered corticosteroids without a clinically significant rise in IOP.
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The primary endpoint of the trial is safety of EC-104, while the secondary endpoint is efficacy through week 24 as assessed by spectral domain OCT.
“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,” Scott Cousins, MD, CEO and vice president for research and development at Eclipse Life Sciences, said in the release. “With multiple clinical trial sites now active throughout the U.S., we look forward to continued enrollment in the BETTIS-1 trial as we advance the EC-104 clinical development program.”
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