Nicox releases positive post hoc results from NCX 4251 Phase IIb

Countering an earlier disappointing study, French ophthalmology specialist Nicox (Euronext Paris: COX) today announced positive post hoc results from its Mississippi Phase IIb clinical trial suggesting that once-daily dosed NCX 4251, fluticasone propionate ophthalmic suspension 0.1%, is effective in reducing dry eye symptoms in a subgroup of patients.

The new results show that, for a subgroup of patients scoring more highly for a key sign of dry eye, statistically-significant improvements in a number of dry eye symptoms and improvements in one sign (p=0.0524) were seen. The top-line results from the trial, which did not meet the primary or secondary efficacy endpoints, were reported on September 23, 2021.

The post hoc analyses identified a subgroup of patients (123 of 224 patients) with baseline scores ≥2.0 on a scale of 0 (none) to 4 (severe) for inferior cornea fluorescein staining, a key sign of dry eye disease. In this patient group, the analysis demonstrated a statistically significant difference against placebo for change from baseline in eye dryness scores as assessed on a Visual Analog Scale at Day 8 (p=0.0085), Day 11 (p=0.0020) and Day 15 (p<0.0016).

Statistically-significant differences against placebo were also observed in other symptoms of dry eye disease (photophobia, blurred vision, burning/stinging, foreign body sensation, ocular itching, pain) at all timepoints during treatment (Day 8, Day 11 and Day 15). In some symptoms the effects persisted up to two weeks after the end of treatment. At Day 15, the difference in reduction from baseline in inferior cornea fluorescein staining reached a p-value of 0.0524, which Nicox believes could reach statistical significance with a larger patient population.

FDA meeting scheduled