The study evaluated ocular hypotensive efficacy of VVN539 in subjects with primary open angle glaucoma or ocular hypertension. Credit: Dmitry Kalinovsky /Shutterstock.com.

Vivavision Biotech has reported that its Phase IIa first in human study of VVN539 Ophthalmic Solution in the US has met its primary study endpoints.

The vehicle-controlled, dose-response, double-masked, randomised study has evaluated VVN539’s safety and ocular hypotensive efficacy in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OHT).

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Assessing the ocular hypotensive efficacy of the solution in two concentrations including 0.04% and 0.02% in patients with POAG or OHT is the primary objective of the study.

The secondary objective was to assess the ocular and systemic safety of VVN539.

A statistical and clinically significant decrease in elevated intraocular pressure (IOP) was observed in subjects with OHT and POAG.

The 0.04% solution was found to be superior to its vehicle at all nine diurnal time points over the 21-day study period, while the 0.02% solution showed statistically significant decrease from unmedicated baseline relative to its vehicle at the majority of time points.

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The magnitude of the decrease from unmedicated baseline was observed to be 5–6mm Hg in the 0.04% treated group, while a 1–2mm Hg reduction in IOP was seen in the vehicle group.

VVN539 was also safe and well tolerated in adults with OH or POAG.

Further clinical studies will determine the therapeutic potential of VVN539 compared to a first-line hypotensive drug in a wider population.

VVN539 is a duo MOA small molecule that acts directly at trabecular meshwork and increases the aqueous humor outflow thereby reducing IOP.