Nicox SA Announces Phase 2b Results
Nicox SA has recently released the results from their Mississippi Phase 2b clinical trials. This international ophthalmology company has dedicated themselves to the development of treatments to help maintain vision and improve ocular health.
One of their products in development is the once-daily dosed NCX 4251 – a fluticasone propionate ophthalmic suspension 0.1%. This product was trialed against placebos in patients with acute exacerbations of blepharitis.
Blepharitis is a condition leading to red, swollen, itchy eyelids which can lead to more serious conditions including conjunctivitis.
The primary measure of this Phase 2b trial looked at the proportion of patients achieving complete cure in all three hallmark signs and symptoms of blepharitis, eyelid redness, debris, and discomfort by day 15. Two separate secondary outcome measures were identified as signs and symptoms of dry eye.
The Results
The trial did not meet either primary or secondary efficacy endpoints. However, a signal of NCX 4251’s potential efficacy was seen in the trial. NCX 4251 at 0.1% showed a numerical improvement over a placebo outcome for the primary measure. It also showed a statistically significant difference against placebo surrounding the change from baseline in certain symptoms. They intend to further their data analysis to decide which key signs and symptoms should be the focus for future development.
It was also found safe and well tolerated over the 14 day treatment period, with no adverse or serious side events.
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