Phase 2b trial to evaluate NCX 4251 for blepharitis
Nicox has initiated a phase 2b clinical trial to evaluate NCX 4251 vs. placebo in patients with acute exacerbations of blepharitis, according to a press release.
NCX 4251 (fluticasone propionate nanocrystal ophthalmic suspension) is applied to the eyelids to target the area of inflammation while minimizing intraocular exposure to fluticasone and the risk for developing increased IOP or cataract.
In the Mississippi trial, 200 patients will be randomly assigned to once-daily NCX 4251 0.1% or placebo at up to 10 U.S. sites. The primary endpoint is the proportion of patients that reach a “complete cure” in eyelid redness, debris and discomfort at 15 days. Secondary endpoints include relief from signs and symptoms of dry eye disease, the release said.
“As agreed previously with the U.S. Food and Drug Administration, should NCX 4251 meet the primary efficacy endpoint for blepharitis, the Mississippi trial could represent the first of two pivotal trials needed to support a new drug application for the treatment of blepharitis in the U.S.,” José Boyer, PhD, vice president and interim head of research and development at Nicox, said in the release.
The safety and tolerability of NCX 4251 was previously evaluated in the Danube phase 2 clinical trial. Nicox expects topline results for the Mississippi trial in the fourth quarter of 2021.