NCX 4251 fails to meet primary, secondary endpoints in phase 2b blepharitis trial
NCX 4251 did not meet the primary or secondary efficacy endpoints in a phase 2b clinical trial investigating the ophthalmic suspension in patients with acute exacerbations of blepharitis, according to a press release from Nicox.
However, NCX 4251 (fluticasone propionate ophthalmic suspension 0.1%) did show a signal of potential efficacy over placebo in the primary outcome measure of complete cure at day 15, the release said.
The primary outcome measure of the Mississippi trial was the proportion of patients achieving a complete cure in three signs and symptoms of blepharitis, including eyelid redness, eyelid debris and eyelid discomfort. Secondary endpoints included measures of the signs and symptoms of dry eye disease.
The suspension showed a significant difference compared with placebo in the exploratory endpoint of the change from baseline in the composite score of the same signs and symptoms at day 8 (P = .03), day 11 (P = .01) and day 15 (P = .01). NCX 4251 was well tolerated over 14 days, and there were no serious adverse events.
“We are pleased to see that there is a signal of efficacy in the composite score of the signs and symptoms of blepharitis. We will continue to analyze the significant amount of data from the trial with the goal of discussing the future development plan in a meeting with the United States Food and Drug Administration early next year,” Michele Garufi, chairman and CEO of Nicox, said in the release.