Post hoc analysis finds NCX 4251 may be effective in some patients with dry eye
NCX 4251 may be effective at reducing dry eye disease symptoms in a specific subgroup of patients, according to a press release from Nicox.
NCX 4251(fluticasone propionate ophthalmic suspension 0.1%) failed to meet primary or secondary efficacy endpoints in the phase 2b Mississippi clinical trial, but it may have a path forward following a post hoc analysis of the study results.
In a subgroup of patients with baseline scores of 2 or greater on a scale of 0 to 4 for inferior cornea fluorescein staining, the post hoc analysis showed a statistically significant change from baseline in eye dryness scores as assessed on a visual analog scale with once-daily NCX 4251 compared with placebo, the release said. The change was significant at day 8 (P = .0085), day 11 (P = .0020) and day 15 (P < .0016).
“The positive impact of NCX 4251 on the multitude of symptoms associated with dry eye disease in a substantial subgroup of blepharitis patients in the trial provides a compelling rationale to explore a targeted approach to the future development of the program with the FDA,” Michele Garufi, chairman and CEO of Nicox, said in the release.
Nicox plans to discuss with the FDA a potential alternative development path for the drug in 2022.
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