NicOx announced results from the phase 2b Mississippi trial which evaluated once-daily dosed NCX 4251 (fluticasone propionate ophthalmic suspension 0.1%) versus placebo in patients with acute exacerbations of blepharitis. The trial did not meet the primary or secondary efficacy endpoints, although potential efficacy was observed in other outcome assessments. The future development of NCX 4251 will be announced following a meeting with the U.S. FDA, expected to take place at the beginning of 2022.
Mississippi was a randomized, double-masked, placebo-controlled trial conducted in 224 patients with acute exacerbations of blepharitis at multiple sites in the U.S. Patients were treated with NCX 4251 or placebo over 14 days. The primary outcome measure was the proportion of patients achieving complete cure in all three hallmark signs and symptoms of blepharitis, eyelid redness, eyelid debris and eyelid discomfort, at Day 15, with two secondary outcome measures on signs and symptoms of dry eye.
NCX 4251 0.1% did show a numerical improvement over placebo in the primary outcome measure of complete cure in eyelid redness, eyelid debris and eyelid discomfort at Day 15. NCX 4251 also sh...
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