Vivavision’s Ophthalmic Solution Significantly Reduces IOP in Phase II Study

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

The study conducted was a Phase 2 clinical trial that followed a double-masked, randomized, vehicle-controlled, dose-response design. Its purpose was to assess the safety and effectiveness of VVN539 Ophthalmic Solution in reducing intraocular pressure (ocular hypotensive efficacy) in individuals diagnosed with primary open angle glaucoma (POAG) or ocular hypertension (OHT).

The primary objective of the study was to evaluate the effectiveness of two different concentrations of VVN539 Ophthalmic Solution (0.04% and 0.02%) in reducing intraocular pressure in patients with POAG or OHT. The secondary objective was to assess the safety of VVN539 Ophthalmic Solution, both in terms of ocular and systemic effects.

In this parallel, double-masked, vehicle, and dose-controlled first-in-human study, the application of VVN539 Ophthalmic Solution on the ocular surface resulted in a significant and clinically meaningful reduction in elevated IOP among individuals diagnosed with ocular hypertension (OHT) and primary open-angle glaucoma (POAG).

The 0.04% concentration of VVN539 Ophthalmic Solution demonstrated statistical superiority over the vehicle at all 9 diurnal time points over the 21-day duration of the study, with a reduction in IOP ranging from 5 to 6 mm Hg from the baseline measurement taken before medication. The 0.02% concentration of VVN539 Ophthalmic Solution also exhibited statistically significant reductions in IOP relative to the vehicle at most time points.

Additionally, in line with similar studies, the group administered the vehicle alone experienced a reduction in IOP ranging from 1 to 2 mm Hg. These Phase 2 study results suggest that VVN539 is well tolerated and safe for use in adult individuals with POAG or ocular hypertension.

In conclusion, VVN539 Ophthalmic Solution demonstrated both statistically and clinically significant ocular hypotensive effects and exhibited favorable tolerability in patients diagnosed with primary open-angle glaucoma and ocular hypertension. Subsequent clinical trials will aim to assess the therapeutic potential of the drug in comparison to a first-line hypotensive medication within a larger patient population.

About VVN539

VVN539 is an innovative, first-in-class small molecule designed for the treatment of glaucoma. It possesses a dual mechanism of action (MOA) and acts directly on the trabecular meshwork to enhance the outflow of aqueous humor, consequently leading to a reduction in intraocular pressure (IOP).

VVN539 has demonstrated remarkable efficacy in lowering IOP in preclinical animal models. With its unique attributes, this pioneering drug is anticipated to be a strong contender in the global glaucoma market.