Nicox has announced new data from a Phase III clinical trial investigating NCX 470 in patients with open-angle glaucoma or ocular hypertension.
NCX 470 is a novel nitric oxide-donating bimatoprost being developed for lowering intraocular pressure (IOP).
The France-based ophthalmology company presented several posters at the tenth World Glaucoma Congress (WGC) held on 28 June – 1 July in Rome, Italy.
The first poster showed adaptive design period results from the Phase III trial (NCT04445519) comparing NCX 470 to latanoprost, a prostaglandin analogue medicine marketed to treat increased ocular pressure.
The adaptive dose selection period tested two concentrations of NCX 470, 0.065% and 0.1% after Phase II trial results suggested that the highest dose might still be below the top of the dose-response curve. However, data analysis showed that the 0.1% concentration demonstrated a 1.73mmHg greater mean diurnal IOP reduction from baseline than latanoprost while the 0.065% concentration reached a 1.37 mmHg mean diurnal IOP reduction.
Nicox also presented data on outcome measures. NCX 470 met the primary efficacy endpoint on non-inferiority to latanoprost at all-specified time points measured in the trial. Also, a statistically greater proportion of subjects with 10mmHg or more IOP reduction in the treatment arm was reported compared to the control cohort. NCX 470 was safe and well tolerated.
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Further development of NCX 470
Nicox is currently conducting another Phase III trial investigating a 0.1% concentrate dose of NCX 470 in the same patient population. The double-masked trial (NCT04630808) compares NCX 470 to latanoprost 0.005%, with the primary endpoint measuring a mean change of IOP. As per a company presentation in April, Nicox expects to present topline results in 2025.
In the poster announcement, Nicox teased about the planned Phase IIIb trial that will further investigate IOP lowering and potential retinal benefits of NCX 470. The company aims to provide an update on its plans in mid-July.
Upcoming initiations are expected in H1 2023 and will include optical coherence tomography (OTC) and episcleral venous pressure (EVP) studies.
Glaucoma is a common eye condition where the optic nerve that connects the eye to the brain becomes damaged, causing irreversible blindness.
A GlobalData disease analysis estimates that in 2030 the prevalent population with glaucoma will reach 50.4 million in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, Japan).
The report also estimates that 2030 market sales will reach $2.79bn in the US, $368m in 5EU (France, Germany, Italy, Spain, UK), and $320m in Japan.